NCT07203820

Brief Summary

This study was planned as a randomized controlled trial to investigate the effect of ready-made picture template coloring activity on children's anxiety and fear before circumcision. Data is planned to be collected between November 2024 and February 2025 with children between the ages of 5-10 who are planned to be circumcised in a hospital in the Southeastern Anatolia Region. The study consists of painting and control groups. The group in which the participants will be included will be determined by the stratified randomization method. The anxiety status of the children in the painting and control groups will be evaluated using the Children's State Anxiety (CSA) and their fears will be evaluated using the Children's Fear Scale (CFS) based on the reports of both the mother and the child before and after painting. Data collection will be completed before the child is circumcised.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable anxiety

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
Last Updated

October 2, 2025

Status Verified

October 1, 2025

Enrollment Period

3 months

First QC Date

January 15, 2025

Last Update Submit

October 1, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Children's State Anxiety

    The scale aims to measure the situational anxiety of children in the 4-10 age group

    4 months

  • Children's Fear Scale

    The scale, which evaluates children's odors with photographs containing facial muscle changes, can be used by children, families, or researchers

    4 months

Study Arms (2)

Ready-Made Picture Template Painting Activity

EXPERIMENTAL

The child will be asked to go to the child with the ready-made picture template and coloring pencils and color the given picture with the colors they want.

Behavioral: Ready-Made Picture Template Painting Activity

Control group

NO INTERVENTION

No procedures other than routine procedures performed in the hospital will be applied to the children in this group

Interventions

The purpose of the study will be explained to the children and their parents before the painting process and verbal and written consent will be obtained from the parents who agree to participate in the study. The child will be asked to go to the child with the ready-made picture template and coloring pencils and color the given picture with the colors they want. Children's anxiety will be assessed using the Children's State Anxiety (CSA) and their fears will be assessed using the Children's Fear Scale (CFS) based on both mother's and child's reports before painting and after the painting process is completed (half an hour after the first measurement).

Ready-Made Picture Template Painting Activity

Eligibility Criteria

Age5 Years - 10 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBoys circumcised in Turkey
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children between the ages of 5-10,
  • who are planned to be circumcised,
  • who are not in pain, and
  • whose parents approve of participating in the study will be included in the study.

You may not qualify if:

  • Children with mental retardation,
  • bleeding disorders, and
  • traumatic experiences such as death and divorce in the last year will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harran University

Sanliurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 15, 2025

First Posted

October 2, 2025

Study Start

February 1, 2025

Primary Completion

May 1, 2025

Study Completion

June 20, 2025

Last Updated

October 2, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations