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

NCT07106606 | Completed

• 1 other identifier: 2022/107
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

anogenital examination; Sexual abuse of child; Child Monitoring Center; Mandala; anxiety

Outcome Measures

Primary Outcomes (2)

• Findings on Anxiety Level

  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

  Baseline, half an hour before the anogenital examination and immediately after anogenital examination

• Findings on Fear Level

  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.

  Baseline, half an hour before the anogenital examination and immediately after anogenital examination

Secondary Outcomes (2)

• Cardiac Pulse Finding

  Baseline, half an hour before the anogenital examination and immediately after anogenital examination

• Respiratory Rate Finding

  Baseline, half an hour before the anogenital examination and immediately after anogenital examination

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

The group completed a structured mandala-coloring activity prior to the examination.

Behavioral: Mandala coloring activity

Control group

NO INTERVENTION

The group only received routine information before the examination.

Interventions

Mandala coloring activity BEHAVIORAL

This technique is a creative art-based relaxation method that aims to reduce children's anxiety and fear levels. The application was carried out to make children feel psychologically safer and calmer before the examination. The selected mandala forms were created in accordance with the attention span, motor skill capacity and visual perception development of children between the ages of 9 and 12 by choosing simple but symbolic structures with moderate level of detail.

Active Comparator

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul Basaksehir Cam and Sakura City Hospital Child Advocacy Center

Istanbul, Basaksehir, 34440, 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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 6, 2025
• Study Start: May 10, 2024
• Primary Completion: January 30, 2025
• Study Completion: June 3, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)