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

Not Applicable

Completed

• Conditions: Pain, Acute
• Interventions: Device: Water-based barrier tape; Device: Silk tape; Device: Hydrocolloid barrier tape

• Registration Number: NCT05064072
• Lead Sponsor: Marmara University

Brief 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.

Detailed 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 Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-09
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-15
• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-09-29
• Last Update Submitted: 2021-09-29
• Study First Posted: 2021-10-01
• Last Update Posted: 2021-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• All the 4-6 weeks infants including interventional process and without any skin diseases

Exclusion Criteria

• The infants receiving treatment without any interventional process
• Those having a skin disease
• Those infants having peripherally inserted central venous catheter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water-based barrier tape	Water-based barrier tape	The infants in experiment 1 group will be applied water-based barrier tape will be used to fix the nasogastric tube
Silk plaster	Silk tape	The silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube
Hydrocolloid barrier tape	Hydrocolloid barrier tape	The infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube

Primary Outcome Measures

Name	Time	Method
Water-based barrier tape	24 hours	To evaluate pain felt by infants following the removal of silk adhesive from water-based barrier tape
Silk Tape	24 hours	To evaluate pain felt by infants following the removal of silk adhesive from infants skin without any barrier tape
Hydrocolloid barrier tape	24 hours	To evaluate pain felt by infants following the removal of silk adhesive from hydrocolloid barrier tape

Trial Locations

Locations (1)

Giresun University Women and Children's Hospital; 🇹🇷 Giresun, Turkey