NCT06583187

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

September 1, 2024

Last Update Submit

March 15, 2025

Conditions

Keywords

anxietychildcircumcisionemotional manifestfearpainmandala painting

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (1)

  • The Wong-Baker Faces Pain Rating Scale

    Baseline

Other Outcomes (3)

  • Children's Fear Scale

    Baseline

  • Children's Emotional Manifestation Scale

    Baseline

  • Children's Anxiety State Scale

    Baseline

Study Arms (2)

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.

Other: Coloring a mandala picture

Interventions

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.

Experimental Group

Eligibility Criteria

Age6 Years - 12 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gümüşhane Hospital Pediatric Clinic

Gümüşhane, 29000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 37589631BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hatice OĞUZHAN, Lecturer

    Gümüşhane Universıty

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 1, 2024

First Posted

September 3, 2024

Study Start

May 1, 2024

Primary Completion

June 15, 2024

Study Completion

August 15, 2024

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations