The Evaluation of Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation: Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain, Acute
- Sponsor
- Marmara University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Water-based barrier tape
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Water-based barrier tape
Time Frame: 24 hours
To evaluate pain felt by infants following the removal of silk adhesive from water-based barrier tape
Silk Tape
Time Frame: 24 hours
To evaluate pain felt by infants following the removal of silk adhesive from infants skin without any barrier tape
Hydrocolloid barrier tape
Time Frame: 24 hours
To evaluate pain felt by infants following the removal of silk adhesive from hydrocolloid barrier tape