NCT05095285

Pain and Comfort During Endotracheal Suction in Premature Neonates

Completed NA Last updated 27 October 2021

What this trial tests

NA trial testing Swaddling in Premature in 48 participants. Completed in 1 October 2020.

Timeline

1 July 2019

Primary endpoint
1 October 2020

1 October 2020

Quick facts

Lead sponsor	Istanbul Aydın University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	48
Start date	1 July 2019
Primary completion	1 October 2020
Estimated completion	1 October 2020
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Swaddling
• Oropharyngeal colostrum

Conditions studied

• Premature — all drugs for Premature →

Sponsor

Istanbul Aydın University

Who can join

Adults 1 Day to 5 Days, any sex, with Premature. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Most of the preterm babies in neonatal units are followed up with invasive mechanical ventilation support. For this reason, endotracheal suction is needed repeatedly in preterm babies in order to open the airway obstruction caused by secretions and to maintain the airway patency. Endotracheal aspiration, which is one of the invasive procedures in which pain is felt most in newborns, is performed by nurses.

Endotracheal suction, which causes pain and discomfort in intensive care units, negatively affects the comfort of patients. Studies emphasize that comfort is an indicator of pain and stress, and the comfort scale is also used in pain and distress assessments.

Effective pain management and the development of pain-related care standards to reduce pain in preterm newborn infants improve clinical and neurodevelopmental outcomes. For this reason, it is necessary to reduce the pain that has an effect on the development of preterm babies.

In pediatric nursing, studies on non-pharmacological methods have increased in recent years in order to increase the comfort of infants and reduce pain and stress, especially during painful and stressful procedures in infants followed in neonatal intensive care units. When the literature is examined, there are few studies measuring the effectiveness of non-pharmacological methods used in reducing pain due to endotracheal suction. There are differences in the effectiveness of the methods applied in the existing studies. Therefore, more observation, research and scientific studies by neonatal nurses are needed to reduce the pain associated with endotracheal suction in preterm newborns.

In this study, swaddling and oropharyngeal colostrum, which are two non-pharmacological methods, will be applied during endotracheal suction to preterm newborns receiving invasive mechanical ventilation support. This experimental study was planned to determine the effect of these two non-pharmacological methods on procedural pain and comfort and to contribute to evidence-based nursing practices.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.