AnxietyNCT07203820
Children's Anxiety and Fear Before Circumcision
A study testing Ready-Made Picture Template Painting Activity in people with Anxiety and Fear, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned as a randomized controlled trial to investigate the effect of ready-made picture template coloring activity on children's anxiety and fear before circumcision. Read more about this study
- Who is it for?
- Ages 5 to 10 years, men only
- What is being tested?
- Ready-Made Picture Template Painting Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 20 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 5 to 10 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 5-10,
- who are planned to be circumcised,
- who are not in pain, and
- whose parents approve of participating in the study will be included in the study.
Who cannot join
- Children with mental retardation,
- bleeding disorders, and
- traumatic experiences such as death and divorce in the last year will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ready-made Picture Template Coloring Activity on Children's Anxiety and Fear Before Circumcision: A Randomized Controlled Trial
This study was planned as a randomized controlled trial to investigate the effect of ready-made picture template coloring activity on children's anxiety and fear before circumcision. Data is planned to be collected between November 2024 and February 2025 with children between the ages of 5-10 who are planned to be circumcised in a hospital in the Southeastern Anatolia Region. The study consists of painting and control groups. The group in which the participants will be included will be determined by the stratified randomization method. The anxiety status of the children in the painting and control groups will be evaluated using the Children's State Anxiety (CSA) and their fears will be evaluated using the Children's Fear Scale (CFS) based on the reports of both the mother and the child before and after painting. Data collection will be completed before the child is circumcised.
- Being tested
- Ready-Made Picture Template Painting Activity
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready-Made Picture Template Painting ActivityBehavioural
The purpose of the study will be explained to the children and their parents before the painting process and verbal and written consent will be obtained from the parents who agree to participate in the study. The child will be asked to go to the child with the ready-made picture template and coloring pencils and color the given picture with the colors they want. Children's anxiety will be assessed using the Children's State Anxiety (CSA) and their fears will be assessed using the Children's Fear Scale (CFS) based on both mother's and child's reports before painting and after the painting process is completed (half an hour after the first measurement).
| Study group | Role | What they receive |
|---|---|---|
| Ready-Made Picture Template Painting Activity | Experimental | The child will be asked to go to the child with the ready-made picture template and coloring pencils and color the given picture with the colors they want. Receives: Behavioral: Ready-Made Picture Template Painting Activity |
| Control group | No intervention | No procedures other than routine procedures performed in the hospital will be applied to the children in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's State Anxiety
The scale aims to measure the situational anxiety of children in the 4-10 age group
Measured: 4 months
Children's Fear Scale
The scale, which evaluates children's odors with photographs containing facial muscle changes, can be used by children, families, or researchers
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Feb 2025
- Primary completion1 May 2025
- Study completion20 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.
- 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
- Crossover
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maksude YILDIRIM, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203820
- Sponsor's protocol ID
- HRÜ/24.21.05
- Status last verified
- Oct 2025
- First submitted
- 15 Jan 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ready-made Picture Template Coloring Activity on Children's Anxiety and Fear Before Circumcision: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07203820
- Acronym / sponsor ID
- HRÜ/24.21.05
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 2 Oct 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.
This study was planned as a randomized controlled trial to investigate the effect of ready-made picture template coloring activity on children's anxiety and fear before circumcision. Data is planned to be collected between November 2024 and February 2025 with children between the ages of 5-10 who are planned to be circumcised in a hospital in the Southeastern Anatolia Region. The study consists of painting and control groups. The group in which the participants will be included will be determined by the stratified randomization method. The anxiety status of the children in the painting and control groups will be evaluated using the Children's State Anxiety (CSA) and their fears will be evaluated using the Children's Fear Scale (CFS) based on the reports of both the mother and the child before and after painting. Data collection will be completed before the child is circumcised.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Ready-Made Picture Template Painting Activity | Experimental | Behavioral: Ready-Made Picture Template Painting ActivityThe child will be asked to go to the child with the ready-made picture template and coloring pencils and color the given picture with the colors they want. |
| Control group | No intervention | –No procedures other than routine procedures performed in the hospital will be applied to the children in this group |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between the ages of 5-10,
- who are planned to be circumcised,
- who are not in pain, and
- whose parents approve of participating in the study will be included in the study.
Key exclusion criteria (3 listed)
- Children with mental retardation,
- bleeding disorders, and
- traumatic experiences such as death and divorce in the last year will not be included in the study.
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 |
|---|---|---|
| Ready-Made Picture Template Painting ActivityThe purpose of the study will be explained to the children and their parents before the painting process and verbal and written consent will be obtained from the parents who agree to participate in the study. The child will be asked to go to the child with the ready-made picture template and coloring pencils and color the given picture with the colors they want. Children's anxiety will be assessed using the Children's State Anxiety (CSA) and their fears will be assessed using the Children's Fear Scale (CFS) based on both mother's and child's reports before painting and after the painting process is completed (half an hour after the first measurement). | Behavioural | Ready-Made Picture Template Painting Activity |
Primary outcome
Children's State Anxiety
Time frame: 4 months
The scale aims to measure the situational anxiety of children in the 4-10 age group
Children's Fear Scale
Time frame: 4 months
The scale, which evaluates children's odors with photographs containing facial muscle changes, can be used by children, families, or researchers
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 2 Oct 2025.
- Individual participant dataSharing planned: No
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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 Ready-Made Picture Template Painting Activity in people with Anxiety and Fear, run by Adiyaman University 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 4 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 2 Oct 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?
Children's State Anxiety (time frame: 4 months). 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 2 Oct 2025.