CircumcisionNCT06583187
Effect of Mandala Coloring of Circumcised Children
A study testing Coloring a mandala picture in people with Circumcision, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of mandala painting on fear, anxiety, emotional symptoms and postoperative pain of circumcised children. Read more about this study
- Who is it for?
- Ages 6 to 12 years, men only
- Conditions the study is for
- Circumcision
- What is being tested?
- Coloring a mandala picture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 15 Aug 2024
- 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 6 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 6-12, Written and verbal consent given by their legal guardians, Can speak and are literate in Turkish, Have sufficient mental development to answer questions
Who cannot join
- Children with congenital urological anomalies, Children with who did not agree to participate in the study and who were not in the specified age group
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gümüşhane Hospital Pediatric Clinic
Gümüşhane, 29000
About this study
Official title: Effect of Mandala Coloring on Fear, Anxiety, Emotional Symptoms and Postoperative Pain of Circumcised Children
The aim of this study was to determine the effect of mandala painting on fear, anxiety, emotional symptoms and postoperative pain of circumcised children.
Read the detailed description
78 volunteer children between the ages of 6-12 who come for circumcision surgery will be randomly divided into two groups: mandala painting group and control group. Children will be evaluated before, during and after the procedure. Pain related to the circumcision procedure will be assessed using FLACC Pain Scale, fear will be assessed using High Fear Scale, anxiety will be assessed using Child Anxiety-State Scale and emotional state will be assessed using Emotional Indicators Scale. In addition, children\'s demographic data will be recorded in the Information Form.
- Conditions
- Circumcision
- Being tested
- Coloring a mandala picture
- Keywords
- anxiety, child, circumcision, emotional manifest, fear, pain, mandala painting
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloring a mandala pictureOther
In the study, the experimental group was taken to their room on the day they came for circumcision and then had them paint mandalas. The coloring books chosen for mandala painting were determined to be appropriate for the age group of the children. The child was given a book and was given the freedom to paint the figures they wanted. Care was taken to ensure that the environment was quiet so that the child would be comfortable and calm. Care was taken to ensure that the crayons used in mandala painting did not contain carcinogenic substances and were anti-allergic.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Routine clinical care will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Before circumcision, the child will be coloring mandala pictures of the pediatric clinic. Receives: Other: Coloring a mandala picture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Information Form
This form prepared by researchers in line with the literature, contains 13 questions regarding the child\'s age, previous hospitalization and surgery, information about the current surgery and who gave the information, the education level of the mother and father, the profession of the mother and father, the place of residence and economic status.
Measured: Baseline
Secondary outcomes (1)
The Wong-Baker Faces Pain Rating Scale
This scale was developed by Donna Wong and Connie Moran Baker in 1981. The scale is suitable for children between the ages of three and eighteen. The scale includes facial expressions that the child can enjoy and enjoy. For this reason, it has been stated that it gives more accurate results. The scale has scores of "0", "2", "4", "6", "8", and "10". "0" indicates no pain and "10" indicates the highest pain. This scale does not have a Cronbach alpha score. It has been reported that reliability studies have not been conducted on such scaling.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 May 2024
- Primary completion15 Jun 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CircumcisionStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Akay, Artvin Coruh University
- Investigators
- Hatice OĞUZHAN, Lecturer, Study chair, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583187
- Sponsor's protocol ID
- Mandala Coloring
- Status last verified
- Mar 2025
- First submitted
- 1 Sep 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yeniay D, Tamdo An L, Yucak Ozdemir A, Ak An LO, Kay R SU. Effects of Videos and Therapeutic Music on Preoperative Anxiety and Postoperative Anxiety and Pain Levels in Boys Who Undergo Circumcision. J Perianesth Nurs. 2023 Dec;38(6):918-924. doi: 10.1016/j.jopan.2023.04.007. Epub 2023 Aug 16.
PubMed 37589631
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mandala Coloring on Fear, Anxiety, Emotional Symptoms and Postoperative Pain of Circumcised Children
- ClinicalTrials.gov ID
- NCT06583187
- Acronym / sponsor ID
- Mandala Coloring
- Conditions
- Circumcision
- Keywords
- anxiety, child, circumcision, emotional manifest, fear, pain, mandala painting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 3 Sep 2024 (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 aim of this study was to determine the effect of mandala painting on fear, anxiety, emotional symptoms and postoperative pain of circumcised children.
Detailed description
78 volunteer children between the ages of 6-12 who come for circumcision surgery will be randomly divided into two groups: mandala painting group and control group. Children will be evaluated before, during and after the procedure. Pain related to the circumcision procedure will be assessed using FLACC Pain Scale, fear will be assessed using High Fear Scale, anxiety will be assessed using Child Anxiety-State Scale and emotional state will be assessed using Emotional Indicators Scale. In addition, children\'s demographic data will be recorded in the Information Form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Routine clinical care will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Other: Coloring a mandala pictureBefore circumcision, the child will be coloring mandala pictures of the pediatric clinic. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the ages of 6-12, Written and verbal consent given by their legal guardians, Can speak and are literate in Turkish, Have sufficient mental development to answer questions
Key exclusion criteria (1 listed)
- Children with congenital urological anomalies, Children with who did not agree to participate in the study and who were not in the specified age group
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 |
|---|---|---|
| Coloring a mandala pictureIn the study, the experimental group was taken to their room on the day they came for circumcision and then had them paint mandalas. The coloring books chosen for mandala painting were determined to be appropriate for the age group of the children. The child was given a book and was given the freedom to paint the figures they wanted. Care was taken to ensure that the environment was quiet so that the child would be comfortable and calm. Care was taken to ensure that the crayons used in mandala painting did not contain carcinogenic substances and were anti-allergic. | Other | Experimental Group |
Primary outcome
Child Information Form
Time frame: Baseline
This form prepared by researchers in line with the literature, contains 13 questions regarding the child\'s age, previous hospitalization and surgery, information about the current surgery and who gave the information, the education level of the mother and father, the profession of the mother and father, the place of residence and economic status.
1 secondary outcome
The Wong-Baker Faces Pain Rating Scale
Time frame: Baseline
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 19 Mar 2025.
- Background: PubMed 37589631Yeniay D, Tamdo An L, Yucak Ozdemir A, Ak An LO, Kay R SU. Effects of Videos and Therapeutic Music on Preoperative Anxiety and Postoperative Anxiety and Pain Levels in Boys Who Undergo Circumcision. J Perianesth Nurs. 2023 Dec;38(6):918-924. doi: 10.1016/j.jopan.2023.04.007. Epub 2023 Aug 16.
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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.
Hatice OĞUZHAN, Lecturer study chair
Gümüşhane Universıty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coloring a mandala picture in people with Circumcision, run by Artvin Coruh 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 1 inclusion and 1 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 19 Mar 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?
Child Information Form (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06583187, which also lists 1 linked publication.
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 19 Mar 2025.