Clinical trial NCT05434364: Comparison Three Methods on Endotracheal Aspiration in Preterm Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Pain, Acute
Physiological Stress
Nursing Care
Comfort
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Kilis 7 Aralik University
First posted: 2022-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 28
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain scores
timeFrame: 6 minutes
measure: Comfort score
timeFrame: 6 minutes
measure: physiological parameter (Heart rate)
timeFrame: 6 minutes
measure: physiological parameter (oxygen saturation)
timeFrame: 6 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University
Study officials:
References:
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.
citation: 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.
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.