The Effect of Stress Ball in Reducing Anxiety and Fear in 6-12 Year Old Children

Not Applicable

Not yet recruiting

• Conditions: Plaster of Paris Injury to Skin
• Interventions: Other: Squeeze the stress ball.

• Registration Number: NCT06486831
• Lead Sponsor: Ataturk University

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Study Start: 2024-08-20
• Primary Completion: 2024-09-01
• Study Completion: 2025-03-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Squeeze the stress ball.	During the plaster intervention process, the experimental group will squeeze the stress ball.

Primary Outcome Measures

Name	Time	Method
Patient Identification Form	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 Outcome Measures

Name	Time	Method
Children's Fear Scale (CFS)	baseline	The CFS, which was first used in 2003, is a scale with proven validity and reliability developed to assess the child's fear/anxiety and its level. The scale includes five different facial expressions, with no fear/anxiety at one end and very intense fear/anxiety at the other end, and is evaluated on a 0-4 point scale. 0: no fear/anxiety, 4: extreme fear and anxiety.