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Completed

NCT Number: NCT07106606

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

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.

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Key information

Conditions

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

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Basaksehir Cam and Sakura City Hospital Child Advocacy Center

Istanbul, Basaksehir, 34440, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Findings on Anxiety Level

    Time frame: 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

  2. Findings on Fear Level

    Time frame: 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 outcomes

  1. Cardiac Pulse Finding

    Time frame: 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.

  2. Respiratory Rate Finding

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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