NCT04678570

Pain Perception Associated With Orogastric Tube Insertion in Preterm Infants

The Effect of White Noise and Swaddling Methods in Reducing the Pain Caused by Orogastric Tube Insertion in Preterm Infants: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Afyonkarahisar Health Sciences University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is a randomized controlled experimental study designed to examine the effect of white noise and swaddling methods in reducing the pain caused by orogastric tube insertion in preterm infants. This study is planned to be conducted with 4 groups, consisting of 3 experimental groups and 1 control group. White noise, swaddling method, and white noise + swaddling methods will be the interventions during the study together with the standard care and procedures for the experimental groups, while the control group will only have standard care and procedures during the study.

Detailed description

This is a randomized controlled experimental study designed to examine the effect of white noise and swaddling methods in reducing the pain caused by orogastric tube insertion in preterm infants. The study will be conducted between 01/01/2021-15/06/2021 in Usak Öztan Hospital Neonatal Intensive Care Unit. The sample of the study is planned to have 132 participants with 33 of them in each of the 4 groups. This study is planned to be conducted with 4 groups, consisting of 3 experimental groups and 1 control group. White noise, swaddling method, and white noise + swaddling methods will be the interventions during the study together with the standard care and procedures for the experimental groups, while the control group will only have standard care and procedures during the study. The interventions that will be used in this study are emphasized in the literature as nonpharmacological methods in reducing and preventing pain. In Usak Öztan Hospital Neonatal Intensive Care Unit, where the study is planned to be conducted, a pre-application will be performed with 10 preterm infants to evaluate the effect of white noise, swaddling, white noise, and swaddling methods on pain perception in preterm infants with an orogastric tube inserted. As the video recordings will be used for the evaluation of the pain, the best area for the video recorder to be placed will be decided during this stage. Insertion of the orogastric tube will be done by the same nurse, who will be briefed about the study concept and will be blinded to the control and the intervention groups, to manage standardization. There will be always a specialist doctor to monitor the infants during this stage for any possible complications.

Conditions

• Orogastric Tube Insertion

Interventions

Type	Name	Description
OTHER	White Noise	The infants will be listened to a song Called " Bebeginiz Aglamasin" from Orhan Osman's colic album which was prepared with the help of Dr. Harvery Karp's ''The Happiest Baby'' album through a portable speaker located at 50 cm away from the infant at 55-decibel frequency. Listening to this song will start 5 minutes before the insertion of the Orogastric Tube, will continue during the procedure and another 5 more minutes after the procedure is completed. The rest of the noise in the environment will be controlled.
OTHER	Swaddling Method	The preterm infants will be placed in the supine position on a 90 cm2 soft cloth. The upper edge of the cloth will be aligned with the infant's shoulder, with the arms placed close to the body, with the horizontal ends of the cloth folded in the opposite direction to cover the top of the body. The arms will be put into flexion and the body will be covered with a cloth. In order not to limit the movements of all limbs of the preterm infant, attention will be paid to leave a finger space between the infant and the cloth cover and to leave a suitable space for the feet to be comfortable before folding the lower part of the cloth cover forward. In the swaddling method, the baby's head can move freely. The swaddling method will be applied approximately 5-10 minutes before the procedure and will be removed from the infant 5 minutes after the procedure. Because swaddling will increase the body temperature of the infant, the standard temperature of the incubator will be lowered.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-05-01
• Completion: 2022-10-15
• First posted: 2020-12-22
• Last updated: 2022-07-21

Locations

1 site across 1 country: Turkey (Türkiye)