Ignite Creation Date:
2024-07-17 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486831
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Brief Title:
The Effect of Stress Ball in Reducing Anxiety and Fear in 6-12 Year Old Children
Sponsor:
Ataturk University
Organization:
Ataturk University
Study Overview
Official Title:
The Effect of Stress Ball in Reducing Anxiety and Fear During Plastering Procedure in Extremity Fractures in Children Aged 6-12 Years
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TSA-2023-12759
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 Childrens Fear Scale and the Childrens Anxiety Scale - Statefulness Scale In addition childrens heart rate respiration blood pressure and SPO2 will be measured
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None