Cold Applications on the Pain Level of Children With Sutures

February 2, 2024 updated by: DİDEM COŞKUN ŞİMŞEK, Firat University

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

Completed

Conditions

Intervention / Treatment

Detailed Description

The experimental groups was applied at the 1st, 2nd and 6th hours after the suture application in the cold applications The different practitioners applied in the Visual Analog Scale after and before in the cold applications to the experimental and control groups

Study Type

Interventional

Enrollment (Actual)

300

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

  • Turkey
    • Campus
      • Elazıg, Campus, Turkey, 2300
        • Fırat university

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

  • Child

Accepts Healthy Volunteers

No

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

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: the cold applications in post-suture pain reduces the child's pain
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
this study was measured the effects of cold application in the children after the suture
Time Frame: 1 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firat University

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)

November 11, 2021

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

July 20, 2022

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Estimated)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

January 1, 2024

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)?

NO

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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