Comparison Three Methods on Endotracheal Aspiration in Preterm Infants

Not Applicable

Completed

• Conditions: Pain, Acute; Comfort; Preterm; Physiological Stress; Nursing Care
• Interventions: Other: Swaddling; Other: Facilitated Tucking; Other: Prone Position

• Registration Number: NCT05434364
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief 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.

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 Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-28
• Study Start: 2024-02-03
• Primary Completion: 2024-07-03
• Status Verified: 2024-09
• Study Completion: 2024-09-03
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Swaddling	Swaddling	giving swaddling before, during and after the procedure
Facilitated Tucking	Facilitated Tucking	giving facilitated tucking before, during and after the procedure
Prone position	Prone Position	giving prone position before, during and after the procedure

Primary Outcome Measures

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

Trial Locations

Locations (1)

Gaziantep University; 🇹🇷 Gaziantep, Turkey