AnxietyNCT07106606
The Effect of the Mandala Method in Reduction of Psychological Distress During Anogenital Examination of Sexually Abused Children Aged 9-12
A study testing Mandala coloring activity in people with Anxiety and Sexual Abuse of Child (If Focus of Attention is on Victim), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Anxiety, Sexual Abuse of Child (If Focus of Attention is on Victim), Fear and Anxiety
- What is being tested?
- Mandala coloring activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2024to 3 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Coming to anogenital examination for the first time,
- The child and parents have native Turkish language skills and the ability to read and write.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Basaksehir Cam and Sakura City Hospital Child Advocacy Center
Istanbul, Basaksehir, 34440
About this study
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.
- Being tested
- Mandala coloring activity
- Keywords
- anogenital examination, Sexual abuse of child, Child Monitoring Center, Mandala, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala coloring activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | The group completed a structured mandala-coloring activity prior to the examination. Receives: Behavioral: Mandala coloring activity |
| Control group | No intervention | The group only received routine information before the examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline, half an hour before the anogenital examination and immediately after anogenital examination
Secondary outcomes (2)
Cardiac Pulse Finding
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.
Measured: Baseline, half an hour before the anogenital examination and immediately after anogenital examination
Respiratory Rate Finding
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.
Measured: Baseline, half an hour before the anogenital examination and immediately after anogenital examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start10 May 2024
- Primary completion30 Jan 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurgül Bozkurt, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106606
- Sponsor's protocol ID
- 2022/107
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available on request
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Mandala Method in Reduction of Psychological Distress During Anogenital Examination of Sexually Abused Children Aged 9-12
- ClinicalTrials.gov ID
- NCT07106606
- Acronym / sponsor ID
- 2022/107
- Keywords
- anogenital examination, Sexual abuse of child, Child Monitoring Center, Mandala, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Behavioral: Mandala coloring activityThe group completed a structured mandala-coloring activity prior to the examination. |
| Control group | No intervention | –The group only received routine information before the examination. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Coming to anogenital examination for the first time,
- The child and parents have native Turkish language skills and the ability to read and write.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandala coloring activityThis 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. | Behavioural | Active Comparator |
Primary outcome
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
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.
2 secondary outcomes
Cardiac Pulse Finding
Time frame: Baseline, half an hour before the anogenital examination and immediately after anogenital examination
Respiratory Rate Finding
Time frame: Baseline, half an hour before the anogenital examination and immediately after anogenital examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: Yes. Data will be made available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala coloring activity in people with Anxiety and Sexual Abuse of Child (If Focus of Attention is on Victim), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Findings on Anxiety Level (time frame: Baseline, half an hour before the anogenital examination and immediately after anogenital examination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.