Effect of Mandala Coloring of Circumcised Children

March 15, 2025 updated by: Gamze Akay, Artvin Coruh University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Gümüşhane, Turkey, 29000
        • Gümüşhane Hospital Pediatric Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Routine clinical care will be applied to the control group. No action will be taken.
Experimental: Experimental Group
Before circumcision, the child will be coloring mandala pictures of the pediatric clinic.
Other: Coloring a mandala picture
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Wong-Baker Faces Pain Rating Scale
Time Frame: Baseline
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.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Fear Scale
Time Frame: Baseline
The Children's Fear Scale (CFS) was used to assess procedural fear. The CFS is a reliable and valid tool for assessing procedural fear in school-aged children between the ages of 5 and 10 years.42 The CFS consists of five faces that are evenly distributed on a horizontal orientation. Each of them represents a different level of fear, the leftmost face marked as 0 and shows no fear, whereas the face on the far right marked as 4, shows the highest level of fear. The individuals reported their own fear levels by placing a mark on the horizontal axis. Before the procedure, the participating children were informed about the way of use of the scale. After the children stated that they understood how the scale can be used, they were asked to say how afraid they were. Children were asked a question as Can you look at these faces and choose the one which shows how afraid you are of having a circumcision? The mark was placed by each child was recorded.
Baseline
Children's Emotional Manifestation Scale
Time Frame: Baseline
The Children's Emotional Manifestation Scale (CEMS) was created in 2005 by Li & Lopez with the aim of offering a simple, objective and consistent method for nurses to determine the emotional behavior and anxiety of children during stressful medical procedures. The Turkish validity and reliability was performed by Çimke & Bayat in 2020. The scale measures emotional markers in children aged from 7 to 12 years undergoing operations. The scale examines 5 dimensions of facial expression, noises made by the child, activity, interaction and cooperation level of the child. Each item is rated from 1 to 5 points. As the points obtained on the scale increase, negative emotional manifestations increase. Assessment is from 5 to 25 points. The Turkish validity and reliability study for the scale found the Cronbach alpha value was 0.94.
Baseline
Children's Anxiety State Scale
Time Frame: Baseline
This scale was developed by Ersig et al. in 2013 measures the state anxiety of children aged 4-10 years. In 2017, Gerçeker et al. carried out Turkish validity study for the scale. CAS-S (State) is designed as a thermometer. At the bottom is the bulb chamber, and upwards are horizontal lines. Each horizontal line represents a score, and the thermometer has 10 points. The bulb chamber at the bottom is 0 points and indicates that there is no anxiety. It is interpreted as the rise of anxiety as it rises upwards. The peak is worth 10 points and refers to the highest anxiety.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artvin Coruh University

Investigators

  • Study Chair: Hatice OĞUZHAN, Lecturer, Gümüşhane Universıty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

June 15, 2024

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

September 1, 2024

First Submitted That Met QC Criteria

September 1, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 15, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Mandala Coloring

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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