PainPAINNCT05077345

The Effects of Different Procedures on Pain Levels at Preterm and Term Infants in Neonatal Intensive Care Unit

An observational study of Pain and Newborn, run by Sanko University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 day to 8 days
Conditions the study is for: Pain, Newborn, Preterm
How many people: 196 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Jan 2019to 30 Mar 2020
How long will I take part?: 1 Week
Phase: Observational
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 1 day to 8 days
All sexes
No healthy volunteers
Child

Study population: The study included 196 newborns who were hospitalized in SANKO University Hospital Level 3 NICU and exposed to different painful procedures during routine clinical practices under Neonatologist follow-up.

Who may be able to join

Preterm and term infants admitted to the NICU for the first time for various reasons with a hospital stay ranging from 1 to 8 days
Preterm and term infants who were cared for in an incubator without any pharmacological or non-pharmacological analgesic therapy, muscle relaxant, and sedation treatment in the last 24 hours before the procedure.

Who cannot join

Exposed to painful procedures more than 3 times in the same day
Infants who diagnosed with osteomyelitis, sepsis, pyejonic arthritis, congenital anomaly (Spina bifida, arthrogryposis multiplex congenita)
Infants with any known neurological diagnosis (Abnormal MRI finding, hydrocephalus, Chiari malformation, asphyxia, periventricular leukomolacia (PVL), acute bilirubin encephalopathy, hypoxic ischemic encephalopathy (HIE))
Infants who had any surgery

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Hatice Adıgüzel
Gaziantep, 27090

Other trials in Turkey (Türkiye)

About this study

Accurate assessment of pain in neonates in the neonatal intensive care unit (NICU) is vital because of the high prevalence of painful experiences, including both daily procedural pain and postoperative pain, in this population. It has been reported that newborns born between the gestational ages (GY) 25-42 and hospitalized in the NICU undergo an average of 14 painful procedures per day in the first 2 weeks of life. The aim of this study is determinin the effect of different procedures on the pain levels of newborns in the Neonatal Intensive Care Unit (NICU).

Read the detailed description

Accurate assessment of pain in neonates in the neonatal intensive care unit (NICU) is vital because of the high prevalence of painful experiences, including both daily procedural pain and postoperative pain, in this population. Exposure of these infants to many mandatory invasive procedures and poor pain management during this time may lead to different results in the short and long term. Every painful application in newborns causes behavioral and physiological instability. Repeated exposure to painful stimuli produces long-term changes in stress-sensitive brain systems such as the hypothalamic-adrenal system and the developing brain. Therefore, evaluation and prevention of pain in newborns is essential. In the NICU, many medical interventions are often performed on infants that are repetitive, painful, but diagnostically necessary. All environmental stress factors can cause physiological changes such as increased pulse, blood pressure, respiratory rate and a decrease in oxygen saturation in newborns. Increasing energy expenditure to overcome these changes may affect physiological functioning, slowing recovery and adversely affecting the organization of the central nervous system (CNS). Heel blood (TC), vascular access (DY), naso and orogastric (NG-OG) catheter insertion, arterial blood collection, tracheal intubation (TE), various rectal procedures, removal of adhesive tapes, umbilical catheter (UK) insertion and removal, Various procedures such as aspiration, chest physiotherapy applications, diaper changing, various hand contacts, and general body care may induce pain responses in newborns. While these responses are associated with low cognitive and motor scores in early childhood, they may result in changes in visual-perceptual ability and somatosensory sensitivity later on. There are many studies in the literature to increase and prove the accuracy of pain assessment tools. However, since the pain treatments used in these studies were also varied, the homogeneity of the evaluations was insufficient. Therefore, more systematic evaluation studies should be conducted on how to improve pain management in NICUs. Finding which of the painful stimuli affects infants more will also guide the use of treatment methods. The aim of this study is to investigate the effects of different procedures applied in the NICU on the pain levels of term and preterm infants.

Conditions: Pain, Newborn, Preterm, Term, Venipuncture
Keywords: Newborn, pain, Preterm, Term, NICU
Medical subject headings: Pain, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05077345
Study group	Role	What they receive
1/Venous blood sampling		The vessel was determined for cannulation and an anatomical tourniquet was applied. Skin antiseptic was prepared. The plastic wings of the winged angioket were held open. The skin over the vein to be accessed was stretched with the fingers of the free hand. The needle was inserted into the skin a few millimeters distal to the point to be inserted, and the blood was vascularized until the education. The cannula was advanced by retracting the stylet. The tourniquet was removed and the cannula was fixed.
2/Heel puncture		The skin was prepared with an antiseptic. The baby's heel was placed at an angle between the thumb and forefinger, with the other fingers grasping the ankle from behind. Pressure was applied to the back of the ankle with the other fingers by taking support against the thumb. The first drop of blood was wiped with sterile gauze by inserting the needle, and the next drops of blood were absorbed into the paper by touching the middle of the ring on the filter paper. An adhesive bandage was applied by applying pressure to the puncture site.
3:Orogastric Catheter insertion		The head of the bed was raised and the newborn was placed on his back. The midpoint distance from the tip of the nose to the ear, xiphoid and umbilicus was measured to determine the insertion length. With one hand, the infant's mouth was opened while his head was stabilized. With the other hand, the MV probe was advanced to the specified depth. The position of the OG probe was confirmed and fixed.
4:Umbilical Catheter insertion		The system was filled with liquid by connecting the tap to the UK. The faucet was turned off, sterile gauze was placed around the umbilical clamp and lifted out of the sterile area. The other assistant held the cord with a clamp and lifted it vertically up and away from the sterile field. The cord and its surroundings were prepared with an antiseptic solution and covered. The umbilicus was tied with a single knot and the cord was cut horizontally with a scalpel. Bleeding on the surface of the cord was wiped with sterile gauze. The cord stump was grasped with toothed forceps close to the vessel to be catheterized. The catheter was placed in the lumen of the vessel and advanced in the vessel. When the catheter exceeded 5 cm, it was aspirated to confirm the intraluminal position. The blood that came with an average of 0.5 ml bolus solution was cleaned and the catheter was fixed.
5:Tracheal Intubation		The head of the infant was positioned in the midline, slightly extended, with the chin up. The head was stabilized with the right hand by turning on the light of the laryngoscope. The blade of the laryngoscope was inserted by sliding the blade over the tongue until the tip of the blade rested on the Vallecula. The blade of the laryngoscope was slid up to open the mouth even more. The other assistant gently dipped it into the suprasternal notch. The concave edge of the tube was held with the right hand, and it was advanced approximately 2 cm, passing it between the vocal cords when the vocal cords and trachea were seen.

What is being measured

The primary outcome is the main question the study is designed to answer.

Neonatal Infant Pain Scale
pain measurement of infants. This scale measures five behavioral groupings (i.e. facial expressions, crying, movements of arms and legs, and awake condition), and one physiological parameter (i.e. breathing patterns) given against pain during invasive procedures in preterm and term infants. The total score is between "0" and "7". The lowest pain level is 0, and the highest pain level is 7. The validity and reliability of the scale were shown in studies that were conducted with premature and term newborns.
Measured: The pain scale was scored in the first 5 minutes following the clinical procedure.
O₂ saturation1
O₂ saturation of the newborn 5 minutes before the painful procedure.
Measured: O₂ saturation value of the newborn 5 minutes before the painful procedure from the pulse oximeter.
heart rate1
the heart rate of the newborn 5 minutes before the painful procedure
Measured: the heart rate of the newborn 5 minutes before the painful procedure from the monitor
heart rate2
the heart rate of the newborn during the painful procedure
Measured: the heart rate of the newborn at the time point of the painful procedure from the monitor
heart rate3
the heart rate of the newborn 5 minutes after the painful procedure
Measured: the heart rate of the newborn 5 minutes after the painful procedure from the monitor
O₂ saturation2
O₂ saturation of the newborn during the painful procedure.
Measured: O₂ saturation of the newborn at the time point of the painful procedure from the pulse oximeter.
O₂ saturation3
O₂ saturation of the newborn 5 minutes after the painful procedure.
Measured: O₂ saturation of the newborn 5 minutes after the painful procedure from the pulse oximeter.

Secondary outcomes (7)

The type and Number of painful procedures
The type and number of painful procedures will be recorded as Heel Puncture (HP), Venous Blood sampling (VB), naso and orogastric (NG-OG) catheter insertion, arterial blood collection, Tracheal Intubation (TI), several rectal procedures, the removal of adhesive tapes, insertion and removal of Umbilical Catheter (UC), and several other procedures such as aspiration, chest physiotherapy procedures,
Measured: The type and number of painful procedures during the first 8 days of life performed on newborns were also recorded.
age (day)
age of the infants will be recorded as day.
Measured: up to 7 days
length (centimeter/cm)
birth length of the infants
Measured: It will be recorded on the pain assesment day.
gender
gender of the infants will be recorde as f/m
Measured: up to 7 days
Diagnosis of the infants (the reason for hospitalization of the infants)
the reason for hospitalization of the infants will be recorded as Prematurity, Respiratuar Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Low birth weight (LBW), Extreme low birth weight (ELBW), Sepsis, Patent Ductus Arteriosus (PDA), Retinopathy of Prematurity (ROP), Small for gestational age (SGA), Premature Rupture of Membranes (PROM).
Measured: up to 7 days
the duration (day) of hospitalization of infants
the duration of hospitalization of all infants will be recorded as day.
Measured: up to 7 days
birth weight
birth weight will be recorded in kilograms(kg)
Measured: at birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 201930 Mar 2020

First posted14 Oct 2021
Study start15 Jan 2019
Primary completion25 Mar 2020
Study completion30 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PainStudies 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 196 participants (actual)
Target duration: 1 Week

IDs, dates and publications

ClinicalTrials.gov ID: NCT05077345
Sponsor's protocol ID: KSU
Acronym: PAIN
Status last verified: Mar 2022
First submitted: 16 Aug 2021
Last updated: 7 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Different Procedures on Pain Levels at Preterm and Term Infants in Neonatal Intensive Care Unit
ClinicalTrials.gov ID: NCT05077345
Acronym / sponsor ID: PAIN / KSU
Conditions: Pain, Newborn, Preterm, Term, Venipuncture
Keywords: Newborn, pain, Preterm, Term, NICU
Study type: Observational
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: Sanko UniversityUniversity, hospital or other
Collaborators: Kahramanmaras Sutcu Imam University
Study start: 15 Jan 2019 (actual)
Primary completion: 25 Mar 2020 (actual)
Study completion: 30 Mar 2020 (actual)
First posted: 14 Oct 2021 (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.

Accurate assessment of pain in neonates in the neonatal intensive care unit (NICU) is vital because of the high prevalence of painful experiences, including both daily procedural pain and postoperative pain, in this population. It has been reported that newborns born between the gestational ages (GY) 25-42 and hospitalized in the NICU undergo an average of 14 painful procedures per day in the first 2 weeks of life. The aim of this study is determinin the effect of different procedures on the pain levels of newborns in the Neonatal Intensive Care Unit (NICU).

Detailed description

Accurate assessment of pain in neonates in the neonatal intensive care unit (NICU) is vital because of the high prevalence of painful experiences, including both daily procedural pain and postoperative pain, in this population. Exposure of these infants to many mandatory invasive procedures and poor pain management during this time may lead to different results in the short and long term. Every painful application in newborns causes behavioral and physiological instability. Repeated exposure to painful stimuli produces long-term changes in stress-sensitive brain systems such as the hypothalamic-adrenal system and the developing brain. Therefore, evaluation and prevention of pain in newborns is essential. In the NICU, many medical interventions are often performed on infants that are repetitive, painful, but diagnostically necessary. All environmental stress factors can cause physiological changes such as increased pulse, blood pressure, respiratory rate and a decrease in oxygen saturation in newborns. Increasing energy expenditure to overcome these changes may affect physiological functioning, slowing recovery and adversely affecting the organization of the central nervous system (CNS). Heel blood (TC), vascular access (DY), naso and orogastric (NG-OG) catheter insertion, arterial blood collection, tracheal intubation (TE), various rectal procedures, removal of adhesive tapes, umbilical catheter (UK) insertion and removal, Various procedures such as aspiration, chest physiotherapy applications, diaper changing, various hand contacts, and general body care may induce pain responses in newborns. While these responses are associated with low cognitive and motor scores in early childhood, they may result in changes in visual-perceptual ability and somatosensory sensitivity later on. There are many studies in the literature to increase and prove the accuracy of pain assessment tools. However, since the pain treatments used in these studies were also varied, the homogeneity of the evaluations was insufficient. Therefore, more systematic evaluation studies should be conducted on how to improve pain management in NICUs. Finding which of the painful stimuli affects infants more will also guide the use of treatment methods. The aim of this study is to investigate the effects of different procedures applied in the NICU on the pain levels of term and preterm infants.

Study design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 1 Week
Number of arms: 5

Arm	Type	Receives
1/Venous blood sampling	–	–The vessel was determined for cannulation and an anatomical tourniquet was applied. Skin antiseptic was prepared. The plastic wings of the winged angioket were held open. The skin over the vein to be accessed was stretched with the fingers of the free hand. The needle was inserted into the skin a few millimeters distal to the point to be inserted, and the blood was vascularized until the education. The cannula was advanced by retracting the stylet. The tourniquet was removed and the cannula was fixed.
2/Heel puncture	–	–The skin was prepared with an antiseptic. The baby's heel was placed at an angle between the thumb and forefinger, with the other fingers grasping the ankle from behind. Pressure was applied to the back of the ankle with the other fingers by taking support against the thumb. The first drop of blood was wiped with sterile gauze by inserting the needle, and the next drops of blood were absorbed into the paper by touching the middle of the ring on the filter paper. An adhesive bandage was applied by applying pressure to the puncture site.
3:Orogastric Catheter insertion	–	–The head of the bed was raised and the newborn was placed on his back. The midpoint distance from the tip of the nose to the ear, xiphoid and umbilicus was measured to determine the insertion length. With one hand, the infant's mouth was opened while his head was stabilized. With the other hand, the MV probe was advanced to the specified depth. The position of the OG probe was confirmed and fixed.
4:Umbilical Catheter insertion	–	–The system was filled with liquid by connecting the tap to the UK. The faucet was turned off, sterile gauze was placed around the umbilical clamp and lifted out of the sterile area. The other assistant held the cord with a clamp and lifted it vertically up and away from the sterile field. The cord and its surroundings were prepared with an antiseptic solution and covered. The umbilicus was tied with a single knot and the cord was cut horizontally with a scalpel. Bleeding on the surface of the cord was wiped with sterile gauze. The cord stump was grasped with toothed forceps close to the vessel to be catheterized. The catheter was placed in the lumen of the vessel and advanced in the vessel. When the catheter exceeded 5 cm, it was aspirated to confirm the intraluminal position. The blood that came with an average of 0.5 ml bolus solution was cleaned and the catheter was fixed.
5:Tracheal Intubation	–	–The head of the infant was positioned in the midline, slightly extended, with the chin up. The head was stabilized with the right hand by turning on the light of the laryngoscope. The blade of the laryngoscope was inserted by sliding the blade over the tongue until the tip of the blade rested on the Vallecula. The blade of the laryngoscope was slid up to open the mouth even more. The other assistant gently dipped it into the suprasternal notch. The concave edge of the tube was held with the right hand, and it was advanced approximately 2 cm, passing it between the vocal cords when the vocal cords and trachea were seen.

Who may qualify

Ages: 1 day to 8 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: The study included 196 newborns who were hospitalized in SANKO University Hospital Level 3 NICU and exposed to different painful procedures during routine clinical practices under Neonatologist follow-up.

Key inclusion criteria (2 listed)

Preterm and term infants admitted to the NICU for the first time for various reasons with a hospital stay ranging from 1 to 8 days
Preterm and term infants who were cared for in an incubator without any pharmacological or non-pharmacological analgesic therapy, muscle relaxant, and sedation treatment in the last 24 hours before the procedure.

Key exclusion criteria (4 listed)

Exposed to painful procedures more than 3 times in the same day
Infants who diagnosed with osteomyelitis, sepsis, pyejonic arthritis, congenital anomaly (Spina bifida, arthrogryposis multiplex congenita)
Infants with any known neurological diagnosis (Abnormal MRI finding, hydrocephalus, Chiari malformation, asphyxia, periventricular leukomolacia (PVL), acute bilirubin encephalopathy, hypoxic ischemic encephalopathy (HIE))
Infants who had any surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Neonatal Infant Pain Scale
Time frame: The pain scale was scored in the first 5 minutes following the clinical procedure.
pain measurement of infants. This scale measures five behavioral groupings (i.e. facial expressions, crying, movements of arms and legs, and awake condition), and one physiological parameter (i.e. breathing patterns) given against pain during invasive procedures in preterm and term infants. The total score is between "0" and "7". The lowest pain level is 0, and the highest pain level is 7. The validity and reliability of the scale were shown in studies that were conducted with premature and term newborns.
O₂ saturation1
Time frame: O₂ saturation value of the newborn 5 minutes before the painful procedure from the pulse oximeter.
O₂ saturation of the newborn 5 minutes before the painful procedure.
heart rate1
Time frame: the heart rate of the newborn 5 minutes before the painful procedure from the monitor
the heart rate of the newborn 5 minutes before the painful procedure
heart rate2
Time frame: the heart rate of the newborn at the time point of the painful procedure from the monitor
the heart rate of the newborn during the painful procedure
heart rate3
Time frame: the heart rate of the newborn 5 minutes after the painful procedure from the monitor
the heart rate of the newborn 5 minutes after the painful procedure
O₂ saturation2
Time frame: O₂ saturation of the newborn at the time point of the painful procedure from the pulse oximeter.
O₂ saturation of the newborn during the painful procedure.
O₂ saturation3
Time frame: O₂ saturation of the newborn 5 minutes after the painful procedure from the pulse oximeter.
O₂ saturation of the newborn 5 minutes after the painful procedure.

7 secondary outcomes

The type and Number of painful procedures
Time frame: The type and number of painful procedures during the first 8 days of life performed on newborns were also recorded.
age (day)
Time frame: up to 7 days
length (centimeter/cm)
Time frame: It will be recorded on the pain assesment day.
gender
Time frame: up to 7 days
Diagnosis of the infants (the reason for hospitalization of the infants)
Time frame: up to 7 days
the duration (day) of hospitalization of infants
Time frame: up to 7 days
birth weight
Time frame: at birth

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 7 Apr 2022.
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.

hatice Adiguzel, PhD principal investigator

Kahramanmaras Sutcu Imam University

mehmet Egilmez, PT study chair

Sanko University

Nevin Ergun, Proffessor study chair

Sanko University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pain and Newborn, run by Sanko University at 1 site 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 2 inclusion and 4 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 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Neonatal Infant Pain Scale (time frame: The pain scale was scored in the first 5 minutes following the clinical procedure.). The study lists 7 primary outcomes in all. 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 NCT05077345.

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 7 Apr 2022.