PretermNCT05430100
Reducing Pain During Orogastric Tube Placement in Preterm
A study testing The effect of usıng breast mılk pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns, The effect of usıng sucrose pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns and The effect of usıng pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns in people with Preterm and Pain, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effectiveness of 3 different methods (breast milk pacifier, sucrose pacifier and pacifier) in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants. Read more about this study
- Who is it for?
- Ages 30 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm, Pain, Nursing Caries
- What is being tested?
- The effect of usıng breast mılk pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns, The effect of usıng sucrose pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns and The effect of usıng pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Jul 2022to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A gestational age of 30-34 weeks ,
- Having his mother's milk
- Stable state of health
- The fact that the preterm baby has not previously had an orogastic tube inserted
- Having spontaneous breathing
- Being fed through the orogastric tube
Show all 9Show fewer
- Not taking opioids or non-opioid analgesics
- He did not receive a painful stimulus until 30 minutes before the intervention,
- Volunteer consent of the parents of the preterm neonate to participate in the study
Who cannot join
- Have any congenital abnormalities on the face or oral cavity,
- The need for a ventilator,
- Having a congenital and genetic anomaly,
- Use of analgesic / Narcotic analgesic drugs,
- The mother has any substance abuse,
- Receiving continuous sedative therapy,
- Congenital malformation that can cause asphyxia and affect breathing
- Preterm newborns with intracranial hemorrhage formed the exclusion criteria of the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara University
Ankara
University of Health Sciences Turkey
Ankara
About this study
Official title: The Effect of usıng Breast mılk pacıfıer, Sucrose pacıfıer and pacıfıer ın reducıng the paın That Occurs durıng orogastrıc Tube ınsertıon ın Preterm Newborns
The aim of this study is to determine the effectiveness of 3 different methods (breast milk pacifier, sucrose pacifier and pacifier) in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants. The study was planned as a randomized controlled experimental study.
Read the detailed description
Babies born before the 37th week of pregnancy are defined as preterm. Preterm newborns need Neonatal Intensive Care Unit (NICU) due to their immature characteristics. NICU includes many diagnostic and therapeutic procedures associated with pain. Babies are exposed to many painful procedures during their stay in the NICU. The International Association for the Study of Pain (IASP) defines pain as "an uncomfortable sensory and emotional experience that develops as a result of existing or potential tissue damage or is described by this damage".
It is known that pain begins to be felt by the fetus from the intrauterine second trimester. Especially, preterm newborns are more vulnerable to the effects of pain exposure due to their developing central and peripheral nervous systems and are more sensitive to pain due to low pain thresholds. Therefore, developing appropriate pain control strategies, especially for preterm newborns, is both a medical and ethical responsibility. In their study, Zhao et al. defined pain as a complex and multidimensional phenomenon experienced in the NICU for preterm newborns. In a study by Mooney-Leber et al. with 430 newborns, it was stated that approximately 80 painful procedures were performed without specific analgesia. Reducing the pain of term and preterm newborns experiencing pain with effective and safe methods is a fundamental right of all newborns.
The sucking reflex in preterm newborns is 28th in intrauterine life. it begins to develop after 32-34 weeks of gestation. during the gestational week, sucking and swallowing reflexes develop. Preterm newborns admitted to NICU are fed through the orogastric tube (OGT) until they can coordinate their sucking, swallowing, and breathing. A probe inserted through the mouth into the esophagus (esophagus) and from there into the stomach is called an orogastric tube. Measurement of OGT placement in preterm newborns; it is made in such a way that it comes from the baby's earlobe to the middle line of the mouth, and from there to the middle line between the Deciphoid protrusion and the umbilical cord. Taking the black markers on the probe as reference points, the length of the probe is adjusted accordingly, the tip should not be touched so that the tip of the probe is not contaminated. The process is stopped when the OGT reaches the point measured before the operation. The stomach contents are checked. OGT is detected at the edge of the mouth when it is sure of its location.
The placement and use of OGT is one of the most common nursing practices applied as a therapeutic and diagnostic method in NICU . It is used for enteral nutrition, drug administration, drainage of the contents of the stomach/small intestine or for decompression and gastric analysis in hospitalized infants. However, OGT placement is a painful, stressful and troublesome procedure for preterm newborns. In preterm newborns, OGT placement is performed frequently until the development of the sucking and swallowing reflex is completed. The fact that the pain is felt intensely, the application is frequent, causes more pain in preterm newborns. It has been stated that recurrent pain leads to decreased brain oxygenation, causing excitotoxic damage to the developing neurons of newborn babies, increasing anxiety, changing sensitivity to pain, stress-related diseases, hyperactivity, attention deficit and may have negative effects on the development of social abilities.
Atraumatic care, which is included in nursing approaches, is defined as therapeutic care or interventions that eliminate or minimize physical stress factors. In line with atraumatic nursing care, pain management is considered as a basic element of care. Newborn nurses closely testify to pain and stress. For the prevention of pain, it is important to provide individual and holistic nursing care. Accordingly, the knowledge of pharmacological and non-pharmacological methods in the management of pain by the nurse has a positive effect on the evaluation of pain in infants and pain management. The use of non-pharmacological methods that are easy to apply and low in cost by neonatal nurses is important for effective pain management. Non-pharmacological methods; sucking, sucrose or dextrose, breastfeeding (breast milk), kangaroo care (skin-to-skin contact), wrapping, massage, touching the face, positioning (fetal position), acupuncture and music therapy can be listed as non-nutritious or nutritious. When the literature is examined, it is stated that it is more effective to use more than one non-pharmacological method together in the use of non-pharmacological methods instead of their use alone . Given the frequency of OGT administration and the sensitivity of preterm infants, ensuring the management of pain during the OGT process will positively affect the development of the preterm baby. There are studies in the literature that different non-pharmacological methods used in OGT placement are effective in reducing pain in preterm newborns. In this study, a study planned in which the methods of using breast milk pacifiers, sucrose pacifiers, and pacifiers were compared together to reduce the pain caused by orogastric tube insertion in preterm newborns was not found in the literature.
The use of a pacifier (non-nutritious suction), one of the non-pharmacological methods included in the scope of the study, is used in routine practice to improve the ability to suck in preterm newborns. To stimulate sucking in non-nutritious sucking, a warning is given by touching the cheek, lips, tongue, gums, jaw and palate. The purpose of this method is to strengthen sucking by stimulating the oral motor functions of the preterm baby. In this way, coordination between sucking, swallowing and during respiration is supported. It is stated that sucrose, which will be used as another method, is effective in reducing pain in some studies, but there may be problems in terms of cost and access in routine applications. Breast milk is a miraculous food that meets all the needs of the newborn in terms of the components it contains, and it has the property of preventing the transmission of pain sensation by stimulating opioids with the nutrients it contains and blocking the pain fibers. It is evaluated that determining the effects on pain management by comparing the pacifier, breast milk pacifier and sucrose pacifier methods in reducing the pain that will occur during the OGT insertion procedure in preterm newborns, the outcomes will contribute to the literature by guiding the effective pain management during the OGT procedure in preterm newborns hospitalized in the NICU.
Hypotheses Of The Study:
In reducing the pain caused by OGT insertion in preterm infants, Hypothesis 0 (H0): There is no difference between breast mılk pacıfıers, sucrose pacıfıers and pacıfıers methods.
Hypothesis 1.1 (H1.1): The breast mılk pacıfıers method is more effective than the control group.
Hypothesis 1.2 (H1.2): The sucrose pacıfıers method is more effective than the control group.
Hypothesis 1.3 (h.1.3): The pacifier method is more effective than the control group.
Hypothesis 1.4 (H1.4): The breast milk pacifier method is more effective than the sucrose pacifier group.
Hypothesis 1.5 (H1.5): The breast milk pacifier method is more effective than the pacifier group.
Hypothesis 1.6 (H1.6): The sucrose pacıfıers method is more effective than breast milk pacifier group.
Hypothesis 1.7 (H1.7): The sucrose pacıfıers method is more effective than pacifier group.
Hypothesis 1.8 (H1.8): The pacifier method is more effective than the breast milk pacifier group.
Hypothesis 1.9 (H1.9): The pacifier method is more effective than the sucrose pacifier group.
Place And Tıme Of The Study:
The study was planned to be carried out after the necessary ethics committee permissions were obtained from the Human Research Ethics Committee of Ankara University Faculty of Medicine. July 2022- july 2023 will be conducted at Ankara University Neonatal Intensive Care Unit. There are 30 nurses in the Neonatal Intensive Care Unit and 4. It serves up to the step.
Unıverse And Sample Of The Study:
In the analysis of the research hypotheses, it is planned to perform analyzes of two and more than two group comparisons and the highest sample size calculated according to the statistical method to be performed is taken as the basis. In this study, "G. Using the "Power-3.1.9.2" program, the sample size was calculated to compare multiple 3 or more groups at a 95% confidence level. As a result of the analysis, α=0.05, the standardized effect size was taken as 0.460461 (high grade) using a similar study conducted in this field earlier, and the minimum sample volume was calculated as 56 with a theoretical strength of 0.80.
- Conditions
- Preterm, Pain, Nursing Caries
- Being tested
- The effect of usıng breast mılk pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns, The effect of usıng sucrose pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns, The effect of usıng pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns
- Keywords
- Pain, preterm, orogastric tube, Neonatal Intensive Care Unit
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effect of usıng breast mılk pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newbornsOther
Also called Sucrose Pacifiers Group, Pacifiers Group
5 Minutes before the OGT insertion, the camera recording will be started and the preterm newborn will be given a breast milk pacifier. After the breast milk pacifier in the OGT intervention group is placed in the mouth as a leak from the edge of the given baby's mouth, the baby's esophagus will be placed by advancing from there to the stomach with the swallowing reflex. It will be checked whether the OGT is in the right place. Registration will be stopped after the evaluation period is completed and the baby is provided with comfort. But the recording will continue so that there are no time restrictions for tracking the crying time of the baby who continues to cry during placement. In terms of the reliability of the research results, nothing should be given orally to a preterm newborn at least 30 minutes before the procedure.
The effect of usıng sucrose pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newbornsOther
Also called Breast Milk Pacifiers Group, Pacifiers Group
The camera recording will be started 5 minutes before the OGT insertion procedure and the newborn will be given a sucrose-sweetened pacifier. After the sucrose-sweetened pacifier in the OGT intervention group is placed in the mouth as a leak from the edge of the given baby's mouth, the baby's esophagus will be placed by advancing from there to the stomach with a swallowing reflex. It will be checked whether the OGT is in the right place. Registration will be stopped after the evaluation period is completed and the baby is provided with comfort. But the recording will be continued so that there are no time restrictions for tracking the crying time of the baby who continues to cry during placement. In terms of the reliability of the research results, nothing should be given orally to a preterm newborn at least 30 minutes before the procedure.
The effect of usıng pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newbornsOther
Also called Breast Milk Pacifiers Group, Sucrose Pacifiers Group
The camera recording will be started 5 minutes before the OGT insertion procedure and the newborn will be given a pacifier. After the pacifier in the OGT intervention group is placed in the mouth as a leak from the edge of the given baby's mouth, the baby's swallowing reflex will be placed by moving the esophagus from there to the stomach. It will be checked whether the OGT is in the right place. Registration will be stopped after the evaluation period is completed and the baby is provided with comfort. But the recording will be continued so that there are no time restrictions for tracking the crying time of the baby who continues to cry during placement.
| Study group | Role | What they receive |
|---|---|---|
| Breast Milk Pacifiers Group | Experimental | To determine the effectiveness of breast milk pacifier in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants. Receives: Other: The effect of usıng breast mılk pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns |
| Sucrose Pacifiers Group | Experimental | To determine the effectiveness of sucrose pacifier in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants. Receives: Other: The effect of usıng sucrose pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns |
| Pacifiers Group | Experimental | To determine the effectiveness of pacifier in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants. Receives: Other: The effect of usıng pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns |
| Control Group | No intervention | The camera recording will be started 5 minutes before the OGT insertion procedure and the routine OGT placement process will be performed. No pain-related procedures are performed during routine OGT in the NICU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Infant Pain Profile - PIPP
PIPP assesses pain with seven indicators. These are three behavioral (forehead wrinkles, enlargement of the eye wings and nose), two physiological (heart rate and oxygen saturation) and two contextual (gestational week and sleep/wake state) variables. The PIPP scale has 7 items to assess the baby's pain, such as gestational week, behavioral status, highest heart rate, lowest oxygen saturation value, forehead wrinkles, squint eyes, and enlarged nasal wings. Each item; It is scored from good to bad as 0, 1, 2, and 3. Premature Baby Pain Profile Scale is evaluated as mild pain between 0-6 points, moderate pain between 7-12 points and severe pain between 13-21 points.
Measured: 1 year
Secondary outcomes (4)
Heart Rate
The number of heartbeats per minute was obtained using an electrocardiographic bedside monitor and continuously recorded by custom computer software. An electrocardiographic bedside monitor was inserted into each of the infants.
Measured: 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure
Oxygen Saturation
Oxygen saturation (SpO2) was obtained using an electrocardiographic bedside monitor and continuously recorded by custom computer software. A separate an electrocardiographic bedside monitor was inserted into each of the infants.
Measured: 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure
Cerebral Oxygen Saturation (rScO2)
Cerebral Oxygen Saturation (rScO2) was obtained using an electrocardiographic bedside monitor and continuously recorded by custom computer software. A separate an electrocardiographic bedside monitor was inserted into each of the infants.
Measured: 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure
Measurement of incidence of adverse events
The safety of different interventions (Breast mılk pacıfıer, Sucrose pacıfıer and Pacıfıer) was assessed by the incidence of adverse events during the study period. The adverse events included: apnea, aspiration, cyanosis, tachycardia, bradycardia, tachypnea, dyspnea. The adverse events were monitored and recorded by specialist neonatal doctor who were blind to the purpose of the study. In case of a side effect, it was planned for the specialist neonatal doctor to stop the intervention immediately and to intervene.
Measured: 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start10 Jul 2022
- Primary completion1 Dec 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 4 groups will be involved in our research. These are; - Breast milk pacifiers group, - Sucrose pacifiers group, - Pacifiers group, - Control group. The numbers to be given to the groups will be determined by lot method. In the research, the assignment of the participants to the groups will be made using the "block randomization method". Randomization will be provided by the researcher using microsoft excel. By typing the numbers from 1 to 100 in cell A, adding the RAND() operation to cell B, the number will be generated in all rows from 1 to 100. Then, the sorting process will be performed on the numbers in cell B and a random list will be created in column A. After evaluating the inclusion criteria and obtaining consent from the participants, it will be determined which group the preterm newborn will be in.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Konukbay, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- DİLEK KONUKBAY, Principal investigator, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430100
- Sponsor's protocol ID
- SBU-KONUKBAY-002
- Status last verified
- Aug 2023
- First submitted
- 31 May 2022
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Campbell-Yeo M, Johnston CC, Benoit B, Disher T, Caddell K, Vincer M, Walker CD, Latimer M, Streiner DL, Inglis D. Sustained efficacy of kangaroo care for repeated painful procedures over neonatal intensive care unit hospitalization: a single-blind randomized controlled trial. Pain. 2019 Nov;160(11):2580-2588. doi: 10.1097/j.pain.0000000000001646.
PubMed 31356452Chawanpaiboon S, Vogel JP, Moller AB, Lumbiganon P, Petzold M, Hogan D, Landoulsi S, Jampathong N, Kongwattanakul K, Laopaiboon M, Lewis C, Rattanakanokchai S, Teng DN, Thinkhamrop J, Watananirun K, Zhang J, Zhou W, Gulmezoglu AM. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019 Jan;7(1):e37-e46. doi: 10.1016/S2214-109X(18)30451-0. Epub 2018 Oct 30.
PubMed 30389451Chen S, Zhang Q, Xie RH, Wen SW, Harrison D. What is the Best Pain Management During Gastric Tube Insertion for Infants Aged 0-12months: A Systematic Review. J Pediatr Nurs. 2017 May-Jun;34:78-83. doi: 10.1016/j.pedn.2016.12.015. Epub 2016 Dec 24.
PubMed 28024900Celik F, Sen S, Karayagiz Muslu G. Effects of Oral Stimulation and Supplemental Nursing System on the Transition Time to Full Breast of Mother and Sucking Success in Preterm Infants: A Randomized Controlled Trial. Clin Nurs Res. 2022 Jun;31(5):891-900. doi: 10.1177/10547738211058312. Epub 2021 Nov 16.
PubMed 34784787Fitri SYR, Lusmilasari L, Juffrie M, Bellieni CV. Modified Sensory Stimulation Using Breastmilk for Reducing Pain Intensity in Neonates in Indonesia: A Randomized Controlled Trial. J Pediatr Nurs. 2020 Jul-Aug;53:e199-e203. doi: 10.1016/j.pedn.2020.04.004. Epub 2020 May 10.
PubMed 32402558Ganguly A, Bhadesia PJ, Phatak AG, Nimbalkar AS, Nimbalkar SM. Pain profile of premature infants during routine procedures in neonatal intensive care: An observational study. J Family Med Prim Care. 2020 Mar 26;9(3):1517-1521. doi: 10.4103/jfmpc.jfmpc_1033_19. eCollection 2020 Mar.
PubMed 32509642Hoarau K, Payet ML, Zamidio L, Bonsante F, Iacobelli S. "Holding-Cuddling" and Sucrose for Pain Relief During Venepuncture in Newborn Infants: A Randomized, Controlled Trial (CASA). Front Pediatr. 2021 Jan 14;8:607900. doi: 10.3389/fped.2020.607900. eCollection 2020.
PubMed 33520895Kamity R, Kapavarapu PK, Chandel A. Feeding Problems and Long-Term Outcomes in Preterm Infants-A Systematic Approach to Evaluation and Management. Children (Basel). 2021 Dec 8;8(12):1158. doi: 10.3390/children8121158.
PubMed 34943354Li L, Wang L, Niu C, Liu C, Lv T, Ji F, Yu L, Yan W, Dou YL, Wang Y, Cao Y, Huang G, Hu X. Early skin contact combined with mother's breastfeeding to shorten the process of premature infants </= 30 weeks of gestation to achieve full oral feeding: the study protocol of a randomized controlled trial. Trials. 2021 Sep 17;22(1):637. doi: 10.1186/s13063-021-05605-x.
PubMed 34535164Lin T, Hu J, Zhang L, Qin X, Liu X, Lan Y, Chen K, You T. Promoting enteral tube feeding safety and performance in preterm infants: A systematic review. Int J Nurs Stud. 2022 Apr;128:104188. doi: 10.1016/j.ijnurstu.2022.104188. Epub 2022 Feb 4.
PubMed 35183863Mala O, Forster EM, Kain VJ. Neonatal Nurse and Midwife Competence Regarding Pain Management in Neonates: A Systematic Review. Adv Neonatal Care. 2022 Apr 1;22(2):E34-E42. doi: 10.1097/ANC.0000000000000911. Epub 2021 Jul 1.
PubMed 34224481McPherson C, Miller SP, El-Dib M, Massaro AN, Inder TE. The influence of pain, agitation, and their management on the immature brain. Pediatr Res. 2020 Aug;88(2):168-175. doi: 10.1038/s41390-019-0744-6. Epub 2020 Jan 2.
PubMed 31896130Mooney-Leber SM, Brummelte S. Neonatal pain and reduced maternal care: Early-life stressors interacting to impact brain and behavioral development. Neuroscience. 2017 Feb 7;342:21-36. doi: 10.1016/j.neuroscience.2016.05.001. Epub 2016 May 7.
PubMed 27167085Mooney-Leber SM, Brummelte S. Neonatal pain and reduced maternal care alter adult behavior and hypothalamic-pituitary-adrenal axis reactivity in a sex-specific manner. Dev Psychobiol. 2020 Jul;62(5):631-643. doi: 10.1002/dev.21941. Epub 2019 Dec 1.
PubMed 31788799Obeidat HM, Dwairej DA, Aloweidi AS. Pain in Preterm Infants: Different Perspectives. J Perinat Educ. 2021 Oct 1;30(4):185-195. doi: 10.1891/J-PE-D-20-00032.
PubMed 34908817
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of usıng Breast mılk pacıfıer, Sucrose pacıfıer and pacıfıer ın reducıng the paın That Occurs durıng orogastrıc Tube ınsertıon ın Preterm Newborns
- ClinicalTrials.gov ID
- NCT05430100
- Acronym / sponsor ID
- SBU-KONUKBAY-002
- Conditions
- Preterm, Pain, Nursing Caries
- Keywords
- Pain, preterm, orogastric tube, Neonatal Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the effectiveness of 3 different methods (breast milk pacifier, sucrose pacifier and pacifier) in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants. The study was planned as a randomized controlled experimental study.
Detailed description
Babies born before the 37th week of pregnancy are defined as preterm. Preterm newborns need Neonatal Intensive Care Unit (NICU) due to their immature characteristics. NICU includes many diagnostic and therapeutic procedures associated with pain. Babies are exposed to many painful procedures during their stay in the NICU. The International Association for the Study of Pain (IASP) defines pain as "an uncomfortable sensory and emotional experience that develops as a result of existing or potential tissue damage or is described by this damage".
It is known that pain begins to be felt by the fetus from the intrauterine second trimester. Especially, preterm newborns are more vulnerable to the effects of pain exposure due to their developing central and peripheral nervous systems and are more sensitive to pain due to low pain thresholds. Therefore, developing appropriate pain control strategies, especially for preterm newborns, is both a medical and ethical responsibility. In their study, Zhao et al. defined pain as a complex and multidimensional phenomenon experienced in the NICU for preterm newborns. In a study by Mooney-Leber et al. with 430 newborns, it was stated that approximately 80 painful procedures were performed without specific analgesia. Reducing the pain of term and preterm newborns experiencing pain with effective and safe methods is a fundamental right of all newborns.
The sucking reflex in preterm newborns is 28th in intrauterine life. it begins to develop after 32-34 weeks of gestation. during the gestational week, sucking and swallowing reflexes develop. Preterm newborns admitted to NICU are fed through the orogastric tube (OGT) until they can coordinate their sucking, swallowing, and breathing. A probe inserted through the mouth into the esophagus (esophagus) and from there into the stomach is called an orogastric tube. Measurement of OGT placement in preterm newborns; it is made in such a way that it comes from the baby's earlobe to the middle line of the mouth, and from there to the middle line between the Deciphoid protrusion and the umbilical cord. Taking the black markers on the probe as reference points, the length of the probe is adjusted accordingly, the tip should not be touched so that the tip of the probe is not contaminated. The process is stopped when the OGT reaches the point measured before the operation. The stomach contents are checked. OGT is detected at the edge of the mouth when it is sure of its location.
The placement and use of OGT is one of the most common nursing practices applied as a therapeutic and diagnostic method in NICU . It is used for enteral nutrition, drug administration, drainage of the contents of the stomach/small intestine or for decompression and gastric analysis in hospitalized infants. However, OGT placement is a painful, stressful and troublesome procedure for preterm newborns. In preterm newborns, OGT placement is performed frequently until the development of the sucking and swallowing reflex is completed. The fact that the pain is felt intensely, the application is frequent, causes more pain in preterm newborns. It has been stated that recurrent pain leads to decreased brain oxygenation, causing excitotoxic damage to the developing neurons of newborn babies, increasing anxiety, changing sensitivity to pain, stress-related diseases, hyperactivity, attention deficit and may have negative effects on the development of social abilities.
Atraumatic care, which is included in nursing approaches, is defined as therapeutic care or interventions that eliminate or minimize physical stress factors. In line with atraumatic nursing care, pain management is considered as a basic element of care. Newborn nurses closely testify to pain and stress. For the prevention of pain, it is important to provide individual and holistic nursing care. Accordingly, the knowledge of pharmacological and non-pharmacological methods in the management of pain by the nurse has a positive effect on the evaluation of pain in infants and pain management. The use of non-pharmacological methods that are easy to apply and low in cost by neonatal nurses is important for effective pain management. Non-pharmacological methods; sucking, sucrose or dextrose, breastfeeding (breast milk), kangaroo care (skin-to-skin contact), wrapping, massage, touching the face, positioning (fetal position), acupuncture and music therapy can be listed as non-nutritious or nutritious. When the literature is examined, it is stated that it is more effective to use more than one non-pharmacological method together in the use of non-pharmacological methods instead of their use alone . Given the frequency of OGT administration and the sensitivity of preterm infants, ensuring the management of pain during the OGT process will positively affect the development of the preterm baby. There are studies in the literature that different non-pharmacological methods used in OGT placement are effective in reducing pain in preterm newborns. In this study, a study planned in which the methods of using breast milk pacifiers, sucrose pacifiers, and pacifiers were compared together to reduce the pain caused by orogastric tube insertion in preterm newborns was not found in the literature.
The use of a pacifier (non-nutritious suction), one of the non-pharmacological methods included in the scope of the study, is used in routine practice to improve the ability to suck in preterm newborns. To stimulate sucking in non-nutritious sucking, a warning is given by touching the cheek, lips, tongue, gums, jaw and palate. The purpose of this method is to strengthen sucking by stimulating the oral motor functions of the preterm baby. In this way, coordination between sucking, swallowing and during respiration is supported. It is stated that sucrose, which will be used as another method, is effective in reducing pain in some studies, but there may be problems in terms of cost and access in routine applications. Breast milk is a miraculous food that meets all the needs of the newborn in terms of the components it contains, and it has the property of preventing the transmission of pain sensation by stimulating opioids with the nutrients it contains and blocking the pain fibers. It is evaluated that determining the effects on pain management by comparing the pacifier, breast milk pacifier and sucrose pacifier methods in reducing the pain that will occur during the OGT insertion procedure in preterm newborns, the outcomes will contribute to the literature by guiding the effective pain management during the OGT procedure in preterm newborns hospitalized in the NICU.
Hypotheses Of The Study:
In reducing the pain caused by OGT insertion in preterm infants, Hypothesis 0 (H0): There is no difference between breast mılk pacıfıers, sucrose pacıfıers and pacıfıers methods.
Hypothesis 1.1 (H1.1): The breast mılk pacıfıers method is more effective than the control group.
Hypothesis 1.2 (H1.2): The sucrose pacıfıers method is more effective than the control group.
Hypothesis 1.3 (h.1.3): The pacifier method is more effective than the control group.
Hypothesis 1.4 (H1.4): The breast milk pacifier method is more effective than the sucrose pacifier group.
Hypothesis 1.5 (H1.5): The breast milk pacifier method is more effective than the pacifier group.
Hypothesis 1.6 (H1.6): The sucrose pacıfıers method is more effective than breast milk pacifier group.
Hypothesis 1.7 (H1.7): The sucrose pacıfıers method is more effective than pacifier group.
Hypothesis 1.8 (H1.8): The pacifier method is more effective than the breast milk pacifier group.
Hypothesis 1.9 (H1.9): The pacifier method is more effective than the sucrose pacifier group.
Place And Tıme Of The Study:
The study was planned to be carried out after the necessary ethics committee permissions were obtained from the Human Research Ethics Committee of Ankara University Faculty of Medicine. July 2022- july 2023 will be conducted at Ankara University Neonatal Intensive Care Unit. There are 30 nurses in the Neonatal Intensive Care Unit and 4. It serves up to the step.
Unıverse And Sample Of The Study:
In the analysis of the research hypotheses, it is planned to perform analyzes of two and more than two group comparisons and the highest sample size calculated according to the statistical method to be performed is taken as the basis. In this study, "G. Using the "Power-3.1.9.2" program, the sample size was calculated to compare multiple 3 or more groups at a 95% confidence level. As a result of the analysis, α=0.05, the standardized effect size was taken as 0.460461 (high grade) using a similar study conducted in this field earlier, and the minimum sample volume was calculated as 56 with a theoretical strength of 0.80.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- A total of 4 groups will be involved in our research. These are; - Breast milk pacifiers group, - Sucrose pacifiers group, - Pacifiers group, - Control group. The numbers to be given to the groups will be determined by lot method. In the research, the assignment of the participants to the groups will be made using the "block randomization method". Randomization will be provided by the researcher using microsoft excel. By typing the numbers from 1 to 100 in cell A, adding the RAND() operation to cell B, the number will be generated in all rows from 1 to 100. Then, the sorting process will be performed on the numbers in cell B and a random list will be created in column A. After evaluating the inclusion criteria and obtaining consent from the participants, it will be determined which group the preterm newborn will be in.
| Arm | Type | Receives |
|---|---|---|
| Breast Milk Pacifiers Group | Experimental | Other: The effect of usıng breast mılk pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newbornsTo determine the effectiveness of breast milk pacifier in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants. |
| Sucrose Pacifiers Group | Experimental | Other: The effect of usıng sucrose pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newbornsTo determine the effectiveness of sucrose pacifier in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants. |
| Pacifiers Group | Experimental | Other: The effect of usıng pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newbornsTo determine the effectiveness of pacifier in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants. |
| Control Group | No intervention | –The camera recording will be started 5 minutes before the OGT insertion procedure and the routine OGT placement process will be performed. No pain-related procedures are performed during routine OGT in the NICU. |
Who may qualify
- Ages
- 30 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- A gestational age of 30-34 weeks ,
- Having his mother's milk
- Stable state of health
- The fact that the preterm baby has not previously had an orogastic tube inserted
- Having spontaneous breathing
Key exclusion criteria (8 listed)
- Have any congenital abnormalities on the face or oral cavity,
- The need for a ventilator,
- Having a congenital and genetic anomaly,
- Use of analgesic / Narcotic analgesic drugs,
- The mother has any substance abuse,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The effect of usıng breast mılk pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newbornsAlso: Sucrose Pacifiers Group, Pacifiers Group5 Minutes before the OGT insertion, the camera recording will be started and the preterm newborn will be given a breast milk pacifier. After the breast milk pacifier in the OGT intervention group is placed in the mouth as a leak from the edge of the given baby's mouth, the baby's esophagus will be placed by advancing from there to the stomach with the swallowing reflex. It will be checked whether the OGT is in the right place. Registration will be stopped after the evaluation period is completed and the baby is provided with comfort. But the recording will continue so that there are no time restrictions for tracking the crying time of the baby who continues to cry during placement. In terms of the reliability of the research results, nothing should be given orally to a preterm newborn at least 30 minutes before the procedure. | Other | Breast Milk Pacifiers Group |
| The effect of usıng sucrose pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newbornsAlso: Breast Milk Pacifiers Group, Pacifiers GroupThe camera recording will be started 5 minutes before the OGT insertion procedure and the newborn will be given a sucrose-sweetened pacifier. After the sucrose-sweetened pacifier in the OGT intervention group is placed in the mouth as a leak from the edge of the given baby's mouth, the baby's esophagus will be placed by advancing from there to the stomach with a swallowing reflex. It will be checked whether the OGT is in the right place. Registration will be stopped after the evaluation period is completed and the baby is provided with comfort. But the recording will be continued so that there are no time restrictions for tracking the crying time of the baby who continues to cry during placement. In terms of the reliability of the research results, nothing should be given orally to a preterm newborn at least 30 minutes before the procedure. | Other | Sucrose Pacifiers Group |
| The effect of usıng pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newbornsAlso: Breast Milk Pacifiers Group, Sucrose Pacifiers GroupThe camera recording will be started 5 minutes before the OGT insertion procedure and the newborn will be given a pacifier. After the pacifier in the OGT intervention group is placed in the mouth as a leak from the edge of the given baby's mouth, the baby's swallowing reflex will be placed by moving the esophagus from there to the stomach. It will be checked whether the OGT is in the right place. Registration will be stopped after the evaluation period is completed and the baby is provided with comfort. But the recording will be continued so that there are no time restrictions for tracking the crying time of the baby who continues to cry during placement. | Other | Pacifiers Group |
Primary outcome
Premature Infant Pain Profile - PIPP
Time frame: 1 year
PIPP assesses pain with seven indicators. These are three behavioral (forehead wrinkles, enlargement of the eye wings and nose), two physiological (heart rate and oxygen saturation) and two contextual (gestational week and sleep/wake state) variables. The PIPP scale has 7 items to assess the baby's pain, such as gestational week, behavioral status, highest heart rate, lowest oxygen saturation value, forehead wrinkles, squint eyes, and enlarged nasal wings. Each item; It is scored from good to bad as 0, 1, 2, and 3. Premature Baby Pain Profile Scale is evaluated as mild pain between 0-6 points, moderate pain between 7-12 points and severe pain between 13-21 points.
4 secondary outcomes
Heart Rate
Time frame: 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure
Oxygen Saturation
Time frame: 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure
Cerebral Oxygen Saturation (rScO2)
Time frame: 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure
Measurement of incidence of adverse events
Time frame: 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Background: PubMed 31356452Campbell-Yeo M, Johnston CC, Benoit B, Disher T, Caddell K, Vincer M, Walker CD, Latimer M, Streiner DL, Inglis D. Sustained efficacy of kangaroo care for repeated painful procedures over neonatal intensive care unit hospitalization: a single-blind randomized controlled trial. Pain. 2019 Nov;160(11):2580-2588. doi: 10.1097/j.pain.0000000000001646.
- Background: PubMed 30389451Chawanpaiboon S, Vogel JP, Moller AB, Lumbiganon P, Petzold M, Hogan D, Landoulsi S, Jampathong N, Kongwattanakul K, Laopaiboon M, Lewis C, Rattanakanokchai S, Teng DN, Thinkhamrop J, Watananirun K, Zhang J, Zhou W, Gulmezoglu AM. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019 Jan;7(1):e37-e46. doi: 10.1016/S2214-109X(18)30451-0. Epub 2018 Oct 30.
- Background: PubMed 28024900Chen S, Zhang Q, Xie RH, Wen SW, Harrison D. What is the Best Pain Management During Gastric Tube Insertion for Infants Aged 0-12months: A Systematic Review. J Pediatr Nurs. 2017 May-Jun;34:78-83. doi: 10.1016/j.pedn.2016.12.015. Epub 2016 Dec 24.
- Background: PubMed 34784787Celik F, Sen S, Karayagiz Muslu G. Effects of Oral Stimulation and Supplemental Nursing System on the Transition Time to Full Breast of Mother and Sucking Success in Preterm Infants: A Randomized Controlled Trial. Clin Nurs Res. 2022 Jun;31(5):891-900. doi: 10.1177/10547738211058312. Epub 2021 Nov 16.
- Background: PubMed 32402558Fitri SYR, Lusmilasari L, Juffrie M, Bellieni CV. Modified Sensory Stimulation Using Breastmilk for Reducing Pain Intensity in Neonates in Indonesia: A Randomized Controlled Trial. J Pediatr Nurs. 2020 Jul-Aug;53:e199-e203. doi: 10.1016/j.pedn.2020.04.004. Epub 2020 May 10.
- Background: PubMed 32509642Ganguly A, Bhadesia PJ, Phatak AG, Nimbalkar AS, Nimbalkar SM. Pain profile of premature infants during routine procedures in neonatal intensive care: An observational study. J Family Med Prim Care. 2020 Mar 26;9(3):1517-1521. doi: 10.4103/jfmpc.jfmpc_1033_19. eCollection 2020 Mar.
- Background: PubMed 33520895Hoarau K, Payet ML, Zamidio L, Bonsante F, Iacobelli S. "Holding-Cuddling" and Sucrose for Pain Relief During Venepuncture in Newborn Infants: A Randomized, Controlled Trial (CASA). Front Pediatr. 2021 Jan 14;8:607900. doi: 10.3389/fped.2020.607900. eCollection 2020.
- Background: PubMed 34943354Kamity R, Kapavarapu PK, Chandel A. Feeding Problems and Long-Term Outcomes in Preterm Infants-A Systematic Approach to Evaluation and Management. Children (Basel). 2021 Dec 8;8(12):1158. doi: 10.3390/children8121158.
- Background: PubMed 34535164Li L, Wang L, Niu C, Liu C, Lv T, Ji F, Yu L, Yan W, Dou YL, Wang Y, Cao Y, Huang G, Hu X. Early skin contact combined with mother's breastfeeding to shorten the process of premature infants </= 30 weeks of gestation to achieve full oral feeding: the study protocol of a randomized controlled trial. Trials. 2021 Sep 17;22(1):637. doi: 10.1186/s13063-021-05605-x.
- Background: PubMed 35183863Lin T, Hu J, Zhang L, Qin X, Liu X, Lan Y, Chen K, You T. Promoting enteral tube feeding safety and performance in preterm infants: A systematic review. Int J Nurs Stud. 2022 Apr;128:104188. doi: 10.1016/j.ijnurstu.2022.104188. Epub 2022 Feb 4.
- Background: PubMed 34224481Mala O, Forster EM, Kain VJ. Neonatal Nurse and Midwife Competence Regarding Pain Management in Neonates: A Systematic Review. Adv Neonatal Care. 2022 Apr 1;22(2):E34-E42. doi: 10.1097/ANC.0000000000000911. Epub 2021 Jul 1.
- Background: PubMed 31896130McPherson C, Miller SP, El-Dib M, Massaro AN, Inder TE. The influence of pain, agitation, and their management on the immature brain. Pediatr Res. 2020 Aug;88(2):168-175. doi: 10.1038/s41390-019-0744-6. Epub 2020 Jan 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DİLEK KONUKBAY principal investigator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The effect of usıng breast mılk pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns, The effect of usıng sucrose pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns and The effect of usıng pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns in people with Preterm and Pain, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature Infant Pain Profile - PIPP (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05430100, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.