PainNCT04156529
The Effect of Feeding Positions During Tube Feeding on Stress, Pain Level and Feeding Tolerance of Preterm Infants
A study testing ESU position and ESRL position in people with Pain and Stress, run by Sibel Serap Ceylan at 1 site in Turkey (Türkiye).
Trial summary
Premature infants have a need for an orogastric or nasogastric feeding tube because of the immaturity of coordination between suck-swallow and breathing. Tube feeding could cause feeding intolerance and stress. One of the recommendations to prevent feeding intolerance is giving suitable position during tube feeding. Read more about this study
- Who is it for?
- Ages 30 to 34 weeks
- Conditions the study is for
- Pain, Stress, Enteral Feeding Intolerance
- What is being tested?
- ESU position and ESRL position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2019to 28 Aug 2019
- 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
- No healthy volunteers
- Child
Who may be able to join
- 30-34 weeks gestational age,
- stable vital signs,
- no oral feeding skills,
- feeding by orogastric tube,
- had parental consent
Who cannot join
- respiratory distress,
- congenital anomalies,
- necrotizing enterocolitis history,
- neurological and cardiological problems,
- receiving analgesic, sedative, or muscle relaxant medication that may affect pain and stress
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Two Different Feeding Positions During Tube Feeding on Stress, Pain Level and Feeding Tolerance of Preterm Infants
Premature infants have a need for an orogastric or nasogastric feeding tube because of the immaturity of coordination between suck-swallow and breathing. Tube feeding could cause feeding intolerance and stress. One of the recommendations to prevent feeding intolerance is giving suitable position during tube feeding. Also, feeding intolerance is related to stress. The aim of this study was to investigate the effect of semi-elevated supine (ESU) and semi-elevated right lateral (ESRL) positions on the stress, pain levels and feeding tolerance of premature infants during the tube feeding (TF). This was a clinical trial with a crossover design in which subjects randomly received a sequence of either ESU position or ESRL position, during the TF.
Read the detailed description
Purpose: The aim of this study was to investigate the effect of semi-elevated supine (ESU) and semi-elevated right lateral (ESRL) positions on the stress, pain levels and feeding tolerance of premature infants during the tube feeding (TF).
Method: This was a clinical trial with a crossover design in which subjects randomly received a sequence of either ESU position or ESRL position, during the TF. The sample size calculation was based on the crossover design. It assumed criteria that included the expectation of minimal differences in the average pain and stress score, 1.0; a difference of 2.0 in the standard deviation between ESU and ESRL positions; power, 0.80 and p < .05. The sample size was calculated to be 34 participants. The inclusion criteria for participants were 30-34 weeks gestational age, stable vital signs, no oral feeding skills, feeding by orogastric tube, and had parental consent. Exclusion criteria were respiratory distress, congenital anomalies, necrotizing enterocolitis history, neurological and cardiological problems, receiving analgesic, sedative, or muscle relaxant medication that may affect pain and stress. The position to be given to the participants during TF first was determined by randomization. The sequence of feeding position was randomized by computer. Sixteen of the infants started TF with ESU position, whereas the other 18 started with ESRL position.
The study data were collected with "Descriptive Properties Form of Premature Newborn", Premature Newborn Follow-up Form", "Newborn Stress Scale", "ALPS-Neo Newborn Pain and Stress Assessment Scale".
For each participant, two feeding positions were applied at consecutive feeding time. Feeding tolerance was assessed by abdominal circumference measurements and checking gastric residuals. The abdominal circumference of the participants was measured with a tape measure before and after TF. Vital signs and oxygen saturation levels were measured before, during and after TF. The stress and pain levels of the participants were evaluated independently by the researchers before, during and after TF. Significance level p <0.05 was used for all statistical analyses. Ethics committee approval, written permission from institutions and families were obtained for conducting the study.
- Conditions
- Pain, Stress, Enteral Feeding Intolerance
- Being tested
- ESU position, ESRL position
- Keywords
- body position, enteral feeding intolerance, nursing care, pain, stress
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESU positionBehavioural
Semi-elevated supine (ESU) position was given during tube feeding
ESRL positionBehavioural
Semi-elevated right lateral (ESRL) position was given during tube feeding
| Study group | Role | What they receive |
|---|---|---|
| ESU position | Experimental | Firstly, the semi-elevated supine position was given to participants during tube feeding Receives: Behavioral: ESU position; Behavioral: ESRL position |
| ESRL position | Experimental | Firstly, the semi-elevated right lateral position was given to participants during tube feeding Receives: Behavioral: ESU position; Behavioral: ESRL position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal pain
ALPS-Neo Newborn Pain and Stress Assessment Scale was used. The ALPS-Neo is a five-item scale including facial expression, breathing pattern, tone of extremities, hand and foot activity, and level of activity. The lowest and the highest scores obtainable from the scale are 0 and 10, respectively. As the score increases, stress and pain increase.
Measured: Four month
Neonatal stress
Newborn Stress Scale was used. The scale includes eight items: face expression, color, respiration, activity level, consolation, muscle tone, extremities, and posture. Each item is scored on the scale 0-2. The minimum score is 0 and the maximum score is 16. As the score increases, the stress level of the infant increases.
Measured: Four month
Feeding intolerance
Abdominal circumference measurements and checking gastric residuals. The abdominal circumference of the participants was measured with a tape measure before and after TF.
Measured: Four month
Secondary outcomes (3)
Heart Rate
A pulse oximetry probe was attached to the foot to measure heart rate. The number of heartbeats per minute was observed from the pulse oximetry monitor.
Measured: Four month
Oxygen Saturation
Oxygen saturation (SpO2) was obtained using a pulse oximetry device. Pulse oximetry measures peripheral arterial oxygen saturation (%) as a surrogate marker for tissue oxygenation.
Measured: Four month
Respiratory Rate
The respiratory rate is the number of breaths a person takes per minute. Respiratory rate was measured by observation.
Measured: Four month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start6 May 2019
- Primary completion15 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sibel Serap Ceylan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sibel Serap Ceylan, Pamukkale University
- Investigators
- Sibel Serap Ceylan, Study director, Pamukkale Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156529
- Sponsor's protocol ID
- PamukkaleUniversity
- Status last verified
- Nov 2019
- First submitted
- 11 Oct 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khatony A, Abdi A, Karimi B, Aghaei A, Brojeni HS. The effects of position on gastric residual volume of premature infants in NICU. Ital J Pediatr. 2019 Jan 8;45(1):6. doi: 10.1186/s13052-018-0591-9.
PubMed 30621733Dsilna A, Christensson K, Gustafsson AS, Lagercrantz H, Alfredsson L. Behavioral stress is affected by the mode of tube feeding in very low birth weight infants. Clin J Pain. 2008 Jun;24(5):447-55. doi: 10.1097/AJP.0b013e3181633fd6.
PubMed 18496310
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Feeding Positions During Tube Feeding on Stress, Pain Level and Feeding Tolerance of Preterm Infants
- ClinicalTrials.gov ID
- NCT04156529
- Acronym / sponsor ID
- PamukkaleUniversity
- Conditions
- Pain, Stress, Enteral Feeding Intolerance
- Keywords
- body position, enteral feeding intolerance, nursing care, pain, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sibel Serap CeylanUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 7 Nov 2019 (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.
Premature infants have a need for an orogastric or nasogastric feeding tube because of the immaturity of coordination between suck-swallow and breathing. Tube feeding could cause feeding intolerance and stress. One of the recommendations to prevent feeding intolerance is giving suitable position during tube feeding. Also, feeding intolerance is related to stress. The aim of this study was to investigate the effect of semi-elevated supine (ESU) and semi-elevated right lateral (ESRL) positions on the stress, pain levels and feeding tolerance of premature infants during the tube feeding (TF). This was a clinical trial with a crossover design in which subjects randomly received a sequence of either ESU position or ESRL position, during the TF.
Detailed description
Purpose: The aim of this study was to investigate the effect of semi-elevated supine (ESU) and semi-elevated right lateral (ESRL) positions on the stress, pain levels and feeding tolerance of premature infants during the tube feeding (TF).
Method: This was a clinical trial with a crossover design in which subjects randomly received a sequence of either ESU position or ESRL position, during the TF. The sample size calculation was based on the crossover design. It assumed criteria that included the expectation of minimal differences in the average pain and stress score, 1.0; a difference of 2.0 in the standard deviation between ESU and ESRL positions; power, 0.80 and p < .05. The sample size was calculated to be 34 participants. The inclusion criteria for participants were 30-34 weeks gestational age, stable vital signs, no oral feeding skills, feeding by orogastric tube, and had parental consent. Exclusion criteria were respiratory distress, congenital anomalies, necrotizing enterocolitis history, neurological and cardiological problems, receiving analgesic, sedative, or muscle relaxant medication that may affect pain and stress. The position to be given to the participants during TF first was determined by randomization. The sequence of feeding position was randomized by computer. Sixteen of the infants started TF with ESU position, whereas the other 18 started with ESRL position.
The study data were collected with "Descriptive Properties Form of Premature Newborn", Premature Newborn Follow-up Form", "Newborn Stress Scale", "ALPS-Neo Newborn Pain and Stress Assessment Scale".
For each participant, two feeding positions were applied at consecutive feeding time. Feeding tolerance was assessed by abdominal circumference measurements and checking gastric residuals. The abdominal circumference of the participants was measured with a tape measure before and after TF. Vital signs and oxygen saturation levels were measured before, during and after TF. The stress and pain levels of the participants were evaluated independently by the researchers before, during and after TF. Significance level p <0.05 was used for all statistical analyses. Ethics committee approval, written permission from institutions and families were obtained for conducting the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESU position | Experimental | Behavioral: ESU position, Behavioral: ESRL positionFirstly, the semi-elevated supine position was given to participants during tube feeding |
| ESRL position | Experimental | Behavioral: ESU position, Behavioral: ESRL positionFirstly, the semi-elevated right lateral position was given to participants during tube feeding |
Who may qualify
- Ages
- 30 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 30-34 weeks gestational age,
- stable vital signs,
- no oral feeding skills,
- feeding by orogastric tube,
- had parental consent
Key exclusion criteria (5 listed)
- respiratory distress,
- congenital anomalies,
- necrotizing enterocolitis history,
- neurological and cardiological problems,
- receiving analgesic, sedative, or muscle relaxant medication that may affect pain and stress
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 |
|---|---|---|
| ESU positionSemi-elevated supine (ESU) position was given during tube feeding | Behavioural | ESRL position, ESU position |
| ESRL positionSemi-elevated right lateral (ESRL) position was given during tube feeding | Behavioural | ESRL position, ESU position |
Primary outcome
Neonatal pain
Time frame: Four month
ALPS-Neo Newborn Pain and Stress Assessment Scale was used. The ALPS-Neo is a five-item scale including facial expression, breathing pattern, tone of extremities, hand and foot activity, and level of activity. The lowest and the highest scores obtainable from the scale are 0 and 10, respectively. As the score increases, stress and pain increase.
Neonatal stress
Time frame: Four month
Newborn Stress Scale was used. The scale includes eight items: face expression, color, respiration, activity level, consolation, muscle tone, extremities, and posture. Each item is scored on the scale 0-2. The minimum score is 0 and the maximum score is 16. As the score increases, the stress level of the infant increases.
Feeding intolerance
Time frame: Four month
Abdominal circumference measurements and checking gastric residuals. The abdominal circumference of the participants was measured with a tape measure before and after TF.
3 secondary outcomes
Heart Rate
Time frame: Four month
Oxygen Saturation
Time frame: Four month
Respiratory Rate
Time frame: Four month
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 8 Nov 2019.
- Results publication: PubMed 30621733Khatony A, Abdi A, Karimi B, Aghaei A, Brojeni HS. The effects of position on gastric residual volume of premature infants in NICU. Ital J Pediatr. 2019 Jan 8;45(1):6. doi: 10.1186/s13052-018-0591-9.
- Results publication: PubMed 18496310Dsilna A, Christensson K, Gustafsson AS, Lagercrantz H, Alfredsson L. Behavioral stress is affected by the mode of tube feeding in very low birth weight infants. Clin J Pain. 2008 Jun;24(5):447-55. doi: 10.1097/AJP.0b013e3181633fd6.
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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.
Sibel Serap Ceylan study director
Pamukkale Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESU position and ESRL position in people with Pain and Stress, run by Sibel Serap Ceylan 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 5 inclusion and 5 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 8 Nov 2019. 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 pain (time frame: Four month). The study lists 3 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 NCT04156529, which also lists 2 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 8 Nov 2019.