69 / 5.000 THE EFFECT OF MANDALA PAINTING ON PAIN, STRESS, AND SLEEP QUALITY IN CHILDREN HOSPITALIZED IN THE BURN UNIT: A RANDOMIZED CONTROLLED STUDY

NCT07145398 | Not Yet Recruiting

• 1 other identifier: Van YuzuncuYıl University
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The mandala coloring method allows patients to focus their attention on a circle and use colors with repetitive movements. This state of focus and relaxation can have positive effects on anxiety and other negative moods. There are a limited number of studies in the literature on the use of mandala coloring in children. Therefore, the study was designed to investigate the effects of mandala coloring on pain, stress, and sleep quality in children hospitalized in the burn unit.

Conditions

Pediatric Burns; Pediatric Burn

Keywords

pediatric burn; mandala painting; paın; stress; sleep quality

Outcome Measures

Primary Outcomes (3)

• Pain Level

  Pain levels will be assessed using the Wong-Baker FACES Pain Rating Scale, which is validated for children. Scores range from 0 (no pain) to 10 (worst pain).

  Baseline (before the intervention) and day 7

• Stress Level

  Stress levels will be measured using the Perceived Stress Scale for Children (ages 7-11). Higher scores indicate greater perceived stress.

  Baseline and day 7

• Sleep Quality

  Sleep quality will be evaluated using the Children's Sleep Habits Questionnaire. Higher scores indicate poorer sleep quality.

  Baseline and day 7

Study Arms (2)

Mandala Coloring

EXPERIMENTAL

Children hospitalized in the burn unit randomized to this group will participate in daily mandala coloring sessions. Each session will last approximately 30 minutes and will be conducted once per day for 7 consecutive days under the supervision of the research team. During these sessions, children will select and color mandala patterns using crayons or colored pencils. Standard burn unit care will also be provided

Behavioral: Mandala Coloring

Control - Standard Care

OTHER

Children in the control group will receive only routine burn unit care without any additional interventions. No mandala coloring sessions will be conducted.

Other: Control - Standard Care

Interventions

Mandala Coloring BEHAVIORAL

Children hospitalized in the burn unit will participate in structured mandala coloring sessions. Each session will last approximately 30 minutes and will be conducted once daily for 7 consecutive days. Children will be provided with printed mandala patterns and coloring materials, and the sessions will be supervised by the research team. The purpose of the intervention is to reduce pain and stress levels and improve sleep quality in burn patients.

Mandala Coloring

Control - Standard Care OTHER

Children in the control group will receive routine burn unit care without any additional interventions. No mandala coloring sessions will be provided.

Control - Standard Care

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Both the parent and the child are willing to participate in the study.
• Child is between 6 and 12 years of age.
• Burn degree is 1st or 2nd degree.
• The child does not have an acute psychiatric diagnosis (e.g., severe anxiety disorder, psychotic conditions).
• The child has basic fine motor skills (e.g., ability to hold a pencil, ability to color).
• The child does not have any chronic illness.
• The child has newly initiated burn treatment.

You may not qualify if:

• Parent or child is not willing to participate in the study.
• Burn degree is 3rd or 4th degree.
• The child has any chronic illness.
• The child has a developmental disorder.
• The child has visual perception impairments (e.g., color blindness, severe visual loss).

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Yuzuncu Yıl University

Van, (541) 398-3680, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Yusuf GÜRGAN

CONTACT

+905442941180; yusuf.gurgan95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: Randomized controlled experimental design with pretest-posttest experiment and control group

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: August 25, 2025
• Primary Completion: January 4, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available upon request starting 6 months after study completion for a period of 3 years.
• Access Criteria: De-identified individual participant data will be available upon request starting 6 months after study completion for a period of 3 years. Access will be granted to qualified researchers who submit a methodologically sound proposal and sign a data sharing agreement. Supporting documents that may be provided include the study protocol, statistical analysis plan, and informed consent form.

Locations

TU (1)