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Clinical Trials/NCT06486831
NCT06486831
Not yet recruiting
Not Applicable

The Effect of Stress Ball in Reducing Anxiety and Fear During Plastering Procedure in Extremity Fractures in Children Aged 6-12 Years

Ataturk University0 sites116 target enrollmentAugust 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Plaster of Paris Injury to Skin
Sponsor
Ataturk University
Enrollment
116
Primary Endpoint
Patient Identification Form
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

The aim of this study was to determine the effect of stress ball application on procedure-related anxiety and fear during plaster cast procedure in children aged 6-12 years.

Detailed Description

Children aged 6-12 years will be randomly divided into two groups: stress ball and control group. Interventions will be applied 1 time per day (2 sessions) for 2 days. Children in the experimental group will be given a stress ball during the plaster procedure and will be asked to squeeze it during the procedure. Children will be assessed before, during and after the intervention. Fear and anxiety related to the cast procedure will be assessed using the Children's Fear Scale, and the Children's Anxiety Scale - Statefulness Scale. In addition, children's heart rate, respiration, blood pressure and SPO2 will be measured.

Registry
clinicaltrials.gov
Start Date
August 20, 2024
End Date
March 20, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zülbiye demir barbak

Lecturer

Ataturk University

Eligibility Criteria

Inclusion Criteria

  • Age between 6 and 12 years (over 12 years old)
  • Absence of any physical and mental illness,
  • Not having taken analgesics in the last six hours
  • Hospitalization was for diagnostic or therapeutic purposes
  • The child and parents are comfortable speaking and understanding Turkish.

Exclusion Criteria

  • Children hospitalized for surgery will not be included in the study.
  • Those who are outside the inclusion criteria will not be included in the study.

Outcomes

Primary Outcomes

Patient Identification Form

Time Frame: baseline

In this form, there are questions about the child's age, gender, weight, age of the mother and father, presence of long-term illness, previous hospitalization status and reason, previous surgery status, presence of medication on continuous use, analgesic intake in the last 6 hours.

Secondary Outcomes

  • Children's Fear Scale (CFS)(baseline)

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