PretermNCT05434364
Comparison Three Methods on Endotracheal Aspiration in Preterm Infants
A study testing Facilitated Tucking, Swaddling and Prone Position in people with Preterm and Pain, Acute, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Stress and pain control are vital for newborns, especially preterm babies. While painful procedures cause physiological changes in the short term, they negatively affect brain development in the long term. Read more about this study
- Who is it for?
- Ages 28 to 35 weeks
- Conditions the study is for
- Preterm, Pain, Acute, Physiological Stress
- What is being tested?
- Facilitated Tucking, Swaddling and Prone Position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2024to 3 Sep 2024
- 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 28 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Having 28-35 weeks of gestation,
- Follow-up as intubated in SIMV mode on mechanical ventilator,
- Follow-up on a ventilator between 1-10 days,
- Having a body weight of ≥1000 g,
- Those who have not taken any opioid or sedative medication until 4 hours before the procedure will be included.
Who cannot join
- Presence of congenital anomaly,
- Chest tube inserted
- Intracranial bleeding,
- Presence of condition/anomaly that will prevent prone tilting,
- Those with a history of epileptic seizures will be excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, Gaziantep, 27310
About this study
Official title: Comparison the Effects of Facilitated Tucking, Swaddling and Prone Position Applied During Endotracheal Aspiration on Pain, Comfort and Physiological Parameters in Preterm Infants
Stress and pain control are vital for newborns, especially preterm babies. While painful procedures cause physiological changes in the short term, they negatively affect brain development in the long term. Non-pharmacological interventions with proven efficacy include: fetal position, sucrose, breastfeeding, breast milk, maternal presence, non-nutritive sucking, swaddling (wrapping) and skin-to-skin contact, as well as developmentally supportive positioning. Evaluating the effectiveness of nursing practices to be performed on babies, scientifically proving the most beneficial application that will both alleviate pain and increase their comfort in painful procedures such as aspiration and being more beneficial to babies are among the most basic benefits. Thanks to these applications, it is predicted that your baby will experience less pain and provide more comfort. Therefore, this study aim to comparison the effects of facilitated tucking, swaddling and prone position applied during endotracheal aspiration on pain, comfort and physiological parameters in preterm infants.
Read the detailed description
The universe of the research; between July-September 2022, patients who are intubated on a mechanical ventilator at 32-36 weeks of gestation (middle preterm group) in Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital Neonatal Intensive Care Unit will consist of. In order to determine the sample size of the study, power analysis was performed using the G*Power (V3.1.9.7) program. According to Cohen's effect size coefficients; Assuming that the effect size (f = 0.4) of the evaluations to be made between four independent groups will be large/large, Taplak and Bayat (2021) found the effect size as 0.932 as a result of the Power analysis based on the PIPP-R results. In this study, it was determined that there should be at least 15 people in all groups (Fetal position, Swaddling, Prone position and control group) according to the new calculation made with 0.932 effect size, 5% alpha (two-sided) and 99% power. Considering that there may be losses during the study, each group will form a sample of 100 infants, 25 infants each. Random assignment of babies to groups will be carried out by the researcher through a computer program (https://www.randomizer.org)/. After determining the groups of premature babies randomly, one group will be given fetal position, one group swaddling position and one group prone position before, during and after endotracheal aspiration. Pain scores (PIPP-R), comfort scores (Comfort Scale) and physiological parameters (Heart peak beat, oxygen saturation value measured by pulse oximetry) 3 minutes before, during and after these nursing practices in the 1st and 3rd minutes after the procedure.
- Conditions
- Preterm, Pain, Acute, Physiological Stress, Nursing Care, Comfort
- Being tested
- Facilitated Tucking, Swaddling, Prone Position
- Medical subject headings
- Premature Birth, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated TuckingOther
giving facilitated tucking before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
SwaddlingOther
swaddling before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
Prone PositionOther
giving prone position before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
| Study group | Role | What they receive |
|---|---|---|
| Facilitated Tucking | Experimental | giving facilitated tucking before, during and after the procedure Receives: Other: Facilitated Tucking |
| Swaddling | Experimental | giving swaddling before, during and after the procedure Receives: Other: Swaddling |
| Prone position | Experimental | giving prone position before, during and after the procedure Receives: Other: Prone Position |
| control | No intervention | Rutin care in the neonatal intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Premature infant pain profile-revised (PIPP-R) (min=0 max=21, the higher the score, the more severe the pain)
Measured: 6 minutes
Comfort score
Newborn Comfort Behavior Scale (min=6 max=30, High scores signify that the infant is not comfortable)
Measured: 6 minutes
physiological parameter (Heart rate)
Measured: 6 minutes
physiological parameter (oxygen saturation)
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start3 Feb 2024
- Primary completion3 Jul 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Kilis 7 Aralik University
- Responsible party
- Principal investigator, SERAP ÖZDEMİR, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434364
- Sponsor's protocol ID
- IstanbulS
- Status last verified
- Sep 2024
- First submitted
- 21 Jun 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Taplak AS, Bayat M. Psychometric Testing of the Turkish Version of the Premature Infant Pain Profile Revised-PIPP-R. J Pediatr Nurs. 2019 Sep-Oct;48:e49-e55. doi: 10.1016/j.pedn.2019.06.007. Epub 2019 Jun 19.
PubMed 31229348Hartley KA, Miller CS, Gephart SM. Facilitated tucking to reduce pain in neonates: evidence for best practice. Adv Neonatal Care. 2015 Jun;15(3):201-8. doi: 10.1097/ANC.0000000000000193.
PubMed 26002861Lopez O, Subramanian P, Rahmat N, Theam LC, Chinna K, Rosli R. The effect of facilitated tucking on procedural pain control among premature babies. J Clin Nurs. 2015 Jan;24(1-2):183-91. doi: 10.1111/jocn.12657. Epub 2014 Jul 24.
PubMed 25060423
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Effects of Facilitated Tucking, Swaddling and Prone Position Applied During Endotracheal Aspiration on Pain, Comfort and Physiological Parameters in Preterm Infants
- ClinicalTrials.gov ID
- NCT05434364
- Acronym / sponsor ID
- IstanbulS
- Conditions
- Preterm, Pain, Acute, Physiological Stress, Nursing Care, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Kilis 7 Aralik University
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 28 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.
Stress and pain control are vital for newborns, especially preterm babies. While painful procedures cause physiological changes in the short term, they negatively affect brain development in the long term. Non-pharmacological interventions with proven efficacy include: fetal position, sucrose, breastfeeding, breast milk, maternal presence, non-nutritive sucking, swaddling (wrapping) and skin-to-skin contact, as well as developmentally supportive positioning. Evaluating the effectiveness of nursing practices to be performed on babies, scientifically proving the most beneficial application that will both alleviate pain and increase their comfort in painful procedures such as aspiration and being more beneficial to babies are among the most basic benefits. Thanks to these applications, it is predicted that your baby will experience less pain and provide more comfort. Therefore, this study aim to comparison the effects of facilitated tucking, swaddling and prone position applied during endotracheal aspiration on pain, comfort and physiological parameters in preterm infants.
Detailed description
The universe of the research; between July-September 2022, patients who are intubated on a mechanical ventilator at 32-36 weeks of gestation (middle preterm group) in Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital Neonatal Intensive Care Unit will consist of. In order to determine the sample size of the study, power analysis was performed using the G*Power (V3.1.9.7) program. According to Cohen's effect size coefficients; Assuming that the effect size (f = 0.4) of the evaluations to be made between four independent groups will be large/large, Taplak and Bayat (2021) found the effect size as 0.932 as a result of the Power analysis based on the PIPP-R results. In this study, it was determined that there should be at least 15 people in all groups (Fetal position, Swaddling, Prone position and control group) according to the new calculation made with 0.932 effect size, 5% alpha (two-sided) and 99% power. Considering that there may be losses during the study, each group will form a sample of 100 infants, 25 infants each. Random assignment of babies to groups will be carried out by the researcher through a computer program (https://www.randomizer.org)/. After determining the groups of premature babies randomly, one group will be given fetal position, one group swaddling position and one group prone position before, during and after endotracheal aspiration. Pain scores (PIPP-R), comfort scores (Comfort Scale) and physiological parameters (Heart peak beat, oxygen saturation value measured by pulse oximetry) 3 minutes before, during and after these nursing practices in the 1st and 3rd minutes after the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Facilitated Tucking | Experimental | Other: Facilitated Tuckinggiving facilitated tucking before, during and after the procedure |
| Swaddling | Experimental | Other: Swaddlinggiving swaddling before, during and after the procedure |
| Prone position | Experimental | Other: Prone Positiongiving prone position before, during and after the procedure |
| control | No intervention | –Rutin care in the neonatal intensive care unit |
Who may qualify
- Ages
- 28 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Having 28-35 weeks of gestation,
- Follow-up as intubated in SIMV mode on mechanical ventilator,
- Follow-up on a ventilator between 1-10 days,
- Having a body weight of ≥1000 g,
- Those who have not taken any opioid or sedative medication until 4 hours before the procedure will be included.
Key exclusion criteria (5 listed)
- Presence of congenital anomaly,
- Chest tube inserted
- Intracranial bleeding,
- Presence of condition/anomaly that will prevent prone tilting,
- Those with a history of epileptic seizures will be excluded.
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 |
|---|---|---|
| Facilitated Tuckinggiving facilitated tucking before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure | Other | Facilitated Tucking |
| Swaddlingswaddling before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure | Other | Swaddling |
| Prone Positiongiving prone position before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure | Other | Prone position |
Primary outcome
Pain scores
Time frame: 6 minutes
Premature infant pain profile-revised (PIPP-R) (min=0 max=21, the higher the score, the more severe the pain)
Comfort score
Time frame: 6 minutes
Newborn Comfort Behavior Scale (min=6 max=30, High scores signify that the infant is not comfortable)
physiological parameter (Heart rate)
Time frame: 6 minutes
physiological parameter (oxygen saturation)
Time frame: 6 minutes
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 15 Oct 2024.
- Results publication: PubMed 31229348Taplak AS, Bayat M. Psychometric Testing of the Turkish Version of the Premature Infant Pain Profile Revised-PIPP-R. J Pediatr Nurs. 2019 Sep-Oct;48:e49-e55. doi: 10.1016/j.pedn.2019.06.007. Epub 2019 Jun 19.
- Results publication: PubMed 26002861Hartley KA, Miller CS, Gephart SM. Facilitated tucking to reduce pain in neonates: evidence for best practice. Adv Neonatal Care. 2015 Jun;15(3):201-8. doi: 10.1097/ANC.0000000000000193.
- Results publication: PubMed 25060423Lopez O, Subramanian P, Rahmat N, Theam LC, Chinna K, Rosli R. The effect of facilitated tucking on procedural pain control among premature babies. J Clin Nurs. 2015 Jan;24(1-2):183-91. doi: 10.1111/jocn.12657. Epub 2014 Jul 24.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated Tucking, Swaddling and Prone Position in people with Preterm and Pain, Acute, run by Istanbul University - Cerrahpasa 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 15 Oct 2024. 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?
Pain scores (time frame: 6 minutes). The study lists 4 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 NCT05434364, which also lists 3 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 15 Oct 2024.