- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05064072
Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation
September 29, 2021 updated by: Marmara University
The Evaluation of Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation: Randomized Controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giresun, Turkey
- Giresun University Women and Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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.
|
Experimental: Hydrocolloid barrier tape
The infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube
|
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
|
Active Comparator: Silk plaster
The silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 hours
|
Hydrocolloid barrier tape
Time Frame: 24 hours
|
To evaluate pain felt by infants following the removal of silk adhesive from hydrocolloid barrier tape
|
24 hours
|
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
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Kemer D, İşler Dalgıç A. Yenidoğanlarda Ağrı Yönetiminde Kullanılan Kanıt Temelli Non-Farmakolojik Hemşirelik Uygulamaları. Balıkesir Sağlık Bilimleri Dergisi. 2020; 9(3):197-204.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Actual)
September 15, 2021
Study Completion (Actual)
September 15, 2021
Study Registration Dates
First Submitted
September 29, 2021
First Submitted That Met QC Criteria
September 29, 2021
First Posted (Actual)
October 1, 2021
Study Record Updates
Last Update Posted (Actual)
October 1, 2021
Last Update Submitted That Met QC Criteria
September 29, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23618724
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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