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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04678570
Study type Interventional
Source Afyonkarahisar Health Sciences University
Contact
Status Active, not recruiting
Phase N/A
Start date January 1, 2021
Completion date October 15, 2022

See also
  Status Clinical Trial Phase
Completed NCT06222047 - Pain and Comfort Level During Orogastric Catheter Insertion in Preterms N/A