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Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation

Pain, Acute Clinical Trial

Official title:
The Evaluation of Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation: Randomized Controlled Study

Clinical Trial Summary

The present study was planned to evaluate the pain of 4-6 weeks infants felt during removal of the adhesive products from newborn's skin used in the fixation of nasogastric tube in neonatal and infant units. The hypothesis of the study is "Water-based barrier tape is more effective to reduce pain than hydrocolloid barrier tape.

Clinical Trial Description

The study was planned as randomized controlled and experimental design to compare the efficiency of three different methods reducing pain during removal adhesive products for 4-6 weeks infants. The universe of the study consisted of 4-6 weeks infants in neonatal and infants clinics of Giresun Women's and Children's Hospital between the dates of July-September 2021. Power analysis was performed through G*Power (v3.1.7) programme in order to determine the number of the sample. At the beginning of the study, a reference study (Kemer, 2020) was used for sample calculation. The effect size was calculated as d=0.561 regarding the assessment of skin condition scores and 120 participants in total should be included in the study as 40 participants for each groups in order to obtain 80% power in the level of α=0.05. Block randomization technique is applied in the study as a randomization method. "As for data collection "Infant description form" and "Neonatal Infant Pain Scale" was used. The scale was filled by two independent observer via double-blind method. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05064072
Study type Interventional
Source Marmara University
Contact
Status Completed
Phase N/A
Start date July 1, 2021
Completion date September 15, 2021
View Details
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