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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07106606
Enrollment
68
Registered
2025-08-06
Start date
2024-05-10
Completion date
2025-06-03
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

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.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Findings on Anxiety LevelBaseline, half an hour before the anogenital examination and immediately after anogenital examinationState 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 LevelBaseline, half an hour before the anogenital examination and immediately after anogenital examinationChildren'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

MeasureTime frameDescription
Cardiac Pulse FindingBaseline, half an hour before the anogenital examination and immediately after anogenital examinationIt 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 FindingBaseline, half an hour before the anogenital examination and immediately after anogenital examinationIt is a form in which the respiration (breaths/min) counts and the scores obtained from the scales are recorded before and after the examination.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026