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

NCT ID: NCT07106606

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-10
• Study Completion Date: 2025-06-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Active Comparator

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

Group Type: ACTIVE_COMPARATOR

Mandala coloring activity

Intervention Type: 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.

Control group

The group only received routine information before the examination.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mandala coloring activity

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Nurgül Bozkurt

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Basaksehir Cam and Sakura City Hospital Child Advocacy Center

Istanbul, Basaksehir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022/107

Identifier Type: -

Identifier Source: org_study_id