Comparison Three Methods on Endotracheal Aspiration in Preterm Infants

Pain, Acute Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05434364
• Other study ID #: IstanbulS
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 3, 2024
• Est. completion date: August 3, 2024

Study information

• Verified date: March 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Serap Ozdemir, PhD
• Phone: +905375438610
• Email: serap8685[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 3, 2024
• Est. primary completion date: May 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 35 Weeks

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Acute Pain
• Comfort
• Nursing Care
• Pain, Acute
• Physiological Stress
• Premature Birth
• Preterm

Intervention

Other:
• Facilitated Tucking
giving facilitated tucking before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
• Swaddling
swaddling before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
• Prone Position
giving prone position before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

References & Publications (3)

Hartley 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. — View Citation

Lopez 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores	Premature infant pain profile-revised (PIPP-R) (min=0 max=21, the higher the score, the more severe the pain)	6 minutes
Primary	Comfort score	Newborn Comfort Behavior Scale (min=6 max=30, High scores signify that the infant is not comfortable)	6 minutes
Primary	physiological parameter (Heart rate)		6 minutes
Primary	physiological parameter (oxygen saturation)		6 minutes