NCT06241690

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1 month

First QC Date

January 19, 2024

Last Update Submit

February 2, 2024

Conditions

Keywords

Cold ApplicationchildNursePainsuture

Outcome Measures

Primary Outcomes (1)

  • this study was measured the effects of cold application in the children after the suture

    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

Study Arms (1)

the cold applications in post-suture pain reduces the child's pain

EXPERIMENTAL

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

Interventions

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 cold applications in post-suture pain reduces the child's pain

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • parents who agreed to participate in the study

You may not qualify if:

  • visually impaired child
  • mentally retarded child
  • speech impaired children
  • without chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat University

Elâzığ, Campus, 2300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2024

First Posted

February 5, 2024

Study Start

November 11, 2021

Primary Completion

December 15, 2021

Study Completion

July 20, 2022

Last Updated

February 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations