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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Acute

Intervention / Treatment
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* Device: Water-based barrier tape
* Device: Hydrocolloid barrier tape
* Device: Silk tape


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Weeks
Maximum Age: 6 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water-based barrier tape<br>The infants in experiment 1 group will be applied water-based barrier tape will be used to fix the nasogastric tube | Device: Water-based barrier tape<br>* The infants in experiment 1 group will be applied water-based barrier tape. The area will be covered by water-based barrier tape to fix nasogastric tube and after waiting 1 minute for drying up it will be fastened by silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the water-based barrier tape, the pain felt by the infants evaluated through Neonatal Infant Pain Scale and the score recorded in the chart. This procedure actualized 3 min. before procedure, during and 3 min after procedure.<br>|
| Experimental: Hydrocolloid barrier tape<br>The infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube | Device: Hydrocolloid barrier tape<br>* As for experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube. The hydrocolloid barrier tape, which was cut and shaped appropriately beforehand, will be applied to the area in order to stabilize the nasogastric tube and the tube will be stabilized with silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the hydrocolloid barrier tape, the pain felt by the infants evaluated with Neonatal Infant Pain Scale and the score recorded in the chart. Since the hydrocolloid barrier tape can stay on the skin for 7 days and the assessment of the pain realized in 7th day and noted down to the chart. Pain score evaluated in 7th day 3 min. before procedure, during and 3 min after procedure<br>|
| Active Comparator: Silk plaster<br>The silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube | Device: Silk tape<br>* The silk tape used in clinic routinely will be used for control group infants to fix the nasogastric tube without any barrier. The silk tape will be 5cm long and it will be changed in every 24 hours. Following the removal of silk tape on the silk tape, the pain felt by the infants evaluated through Neonatal Infant Pain Scale and the score recorded in the chart. This procedure actualized 3 min. before procedure, during and 3 min after procedure<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, pain, adhesives, fixation