Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation
Primary Purpose
Pain, Acute
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Water-based barrier tape
Hydrocolloid barrier tape
Silk tape
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Acute focused on measuring infant, pain, adhesives, fixation
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
Sites / Locations
- Giresun University Women and Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Water-based barrier tape
Hydrocolloid barrier tape
Silk plaster
Arm Description
The infants in experiment 1 group will be applied water-based barrier tape will be used to fix the nasogastric tube
The infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube
The silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube
Outcomes
Primary Outcome Measures
Water-based barrier tape
To evaluate pain felt by infants following the removal of silk adhesive from water-based barrier tape
Hydrocolloid barrier tape
To evaluate pain felt by infants following the removal of silk adhesive from hydrocolloid barrier tape
Silk Tape
To evaluate pain felt by infants following the removal of silk adhesive from infants skin without any barrier tape
Secondary Outcome Measures
Full Information
NCT ID
NCT05064072
First Posted
September 29, 2021
Last Updated
September 29, 2021
Sponsor
Marmara University
1. Study Identification
Unique Protocol Identification Number
NCT05064072
Brief Title
Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation
Official Title
The Evaluation of Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation: Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
infant, pain, adhesives, fixation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Water-based barrier tape
Arm Type
Experimental
Arm Description
The infants in experiment 1 group will be applied water-based barrier tape will be used to fix the nasogastric tube
Arm Title
Hydrocolloid barrier tape
Arm Type
Experimental
Arm Description
The infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube
Arm Title
Silk plaster
Arm Type
Active Comparator
Arm Description
The silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube
Intervention Type
Device
Intervention Name(s)
Water-based barrier tape
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hydrocolloid barrier tape
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Silk tape
Intervention Description
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
Primary Outcome Measure Information:
Title
Water-based barrier tape
Description
To evaluate pain felt by infants following the removal of silk adhesive from water-based barrier tape
Time Frame
24 hours
Title
Hydrocolloid barrier tape
Description
To evaluate pain felt by infants following the removal of silk adhesive from hydrocolloid barrier tape
Time Frame
24 hours
Title
Silk Tape
Description
To evaluate pain felt by infants following the removal of silk adhesive from infants skin without any barrier tape
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
6 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Giresun University Women and Children's Hospital
City
Giresun
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28898671
Citation
Field T. Preterm newborn pain research review. Infant Behav Dev. 2017 Nov;49:141-150. doi: 10.1016/j.infbeh.2017.09.002. Epub 2017 Sep 9.
Results Reference
result
PubMed Identifier
31653303
Citation
Maxwell LG, Fraga MV, Malavolta CP. Assessment of Pain in the Newborn: An Update. Clin Perinatol. 2019 Dec;46(4):693-707. doi: 10.1016/j.clp.2019.08.005. Epub 2019 Aug 19.
Results Reference
result
Citation
Kemer D, İşler Dalgıç A. Yenidoğanlarda Ağrı Yönetiminde Kullanılan Kanıt Temelli Non-Farmakolojik Hemşirelik Uygulamaları. Balıkesir Sağlık Bilimleri Dergisi. 2020; 9(3):197-204.
Results Reference
result
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Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation
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