- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06241690
Cold Applications on the Pain Level of Children With Sutures
the Effect of Post-suture Cold Applications on the Pain Level of Children With Sutures
Purpose:This research was conducted as an experimental study with pretest and posttest control groups in order to evaluate the effect of post-suture cold applications on the pain level of children with sutures.
Design and Methods: This study is a randomised controlled study. In the study, there were 150 children in the experimental group and 150 children in the control group.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Campus
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Elazıg, Campus, Turkey, 2300
- Fırat University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- parents who agreed to participate in the study
Exclusion Criteria:
- -visually impaired child
- mentally retarded child
- speech impaired children
- without chronic disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: the cold applications in post-suture pain reduces the child's pain
The population of the study consists of children aged 12-17 who were treated in the pediatric emergency departments of the designated hospitals between December 2021 and July 2022 and met the working criteria.
The sample consists of 300 children who applied to the pediatric emergency service between December 2021 and July 2022 and met the research criteria.
Socio-Demographic presentation form and Visual Analog Scale were used as data collection tools.
Statistical analysis of the data was made in SPSS 22 package program.
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The experimental groups was applied cold applications immediately after 20 minutes the suture.
Later, The experimental groups was applied cold applications again for 20 minutes 1 hour, 2 hours and 6 hours after the suture.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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this study was measured the effects of cold application in the children after the suture
Time Frame: 1 days
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The experimental groups was applied cold applications immediately after 20 minutes the suture. Later, The experimental groups was applied cold applications again for 20 minutes 1 hour, 2 hours and 6 hours after the suture. The visual Analog Scale were used as data collection tools. The Visual Analog Scale scale was applied before suturing. It was then applied 20 minutes, 1 hour, 2 hours and 6 hours after the suturing procedure. The Visual Analog Scale: A minimum of 0 and a maximum of 10 points are obtained from the scale. A high score from the scale indicates a high level of pain |
1 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- post-suture cold applications
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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