The Effect of the Mandala Method in Reduction of Psychological Distress During Anogenital Examination of Sexually Abused Children Aged 9-12

Not Applicable

Completed

• Conditions: Anxiety; Sexual Abuse of Child (If Focus of Attention is on Victim); Fear and Anxiety

• Registration Number: NCT07106606
• Lead Sponsor: Istanbul University - Cerrahpasa

Brief Summary

The goal of this study is evaluating the effectiveness of a mandala-coloring intervention in reducing psychological distress (fear, state anxiety, and related physiological indicators) during anogenital examinations among sexually abused children aged 9-12.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-10
• Primary Completion: 2025-01-30
• Study Completion: 2025-06-03
• Status Verified: 2025-07
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Coming to anogenital examination for the first time,
• The child and parents have native Turkish language skills and the ability to read and write.

Exclusion Criteria

• Sensory loss at a level that prevents communication with the child,
• Intelligence quotient (IQ) of 55 and below in the records,
• Has a mental or neurological disability that prevents communication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Findings on Anxiety Level	Baseline, half an hour before the anogenital examination and immediately after anogenital examination	State Anxiety Inventory for Children used in this study. It was developed by Spielberger to measure state and trait anxiety levels of children aged 9-12 years. Its adaptation into Turkish, validity and reliability study was conducted by Özusta (1993). It consists of two subscales, "state anxiety" and "trait anxiety", each consisting of 20 items.; State anxiety subscale: Measures how the child feels "at that moment". Trait anxiety subscale: Measures how the child feels "in general". Both subscales give scores ranging from 20 to 60. In this study, since the change in state anxiety level before and after the anogenital examination will be evaluated, the "state anxiety" subscale was predominantly reflected in the findings. However, although trait anxiety was not examined in pre- and post-examination comparison, this subscale was also examined in the pre-test and post-test measurements. The Cronbach's alpha coefficient of state anxiety subscale was 0.82 and trait anxiety subscale was 0.81
Findings on Fear Level	Baseline, half an hour before the anogenital examination and immediately after anogenital examination	Children's Fear Scale: It is a single-item scale consisting of 5 facial expressions. The first facial expression is scored as neutral (0) and the last facial expression as the highest fear (4). It is used to measure the fear level of children before and after the procedure (blood sampling, examination, etc.) (McMurtry et al., 2011). In this study, it was used to determine the change in fear level before and after anogenital examination. Since it includes a single scoring, the reliability coefficient was not calculated.

Secondary Outcome Measures

Name	Time	Method
Cardiac Pulse Finding	Baseline, half an hour before the anogenital examination and immediately after anogenital examination	It is a form in which the pulse (beats/min) counts and the scores obtained from the scales are recorded before and after the examination.
Respiratory Rate Finding	Baseline, half an hour before the anogenital examination and immediately after anogenital examination	It is a form in which the respiration (breaths/min) counts and the scores obtained from the scales are recorded before and after the examination.

Trial Locations

Locations (1)

Istanbul Basaksehir Cam and Sakura City Hospital Child Advocacy Center; 🇹🇷 Istanbul, Basaksehir, Turkey