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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 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-08-25
Last updated
2025-08-28

Condition(s) studied

Pediatric BurnsPediatric Burn

Investigational drug(s) / intervention(s)

Mandala ColoringControl - Standard Care

Mandala Coloring: 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.

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

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Primary outcome measure(s)

  • Pain Level — Baseline (before the intervention) and day 7
    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).
  • Stress Level — Baseline and day 7
    Stress levels will be measured using the Perceived Stress Scale for Children (ages 7-11). Higher scores indicate greater perceived stress.
  • Sleep Quality — Baseline and day 7
    Sleep quality will be evaluated using the Children's Sleep Habits Questionnaire. Higher scores indicate poorer sleep quality.

Trial sites (1)

FacilityCityRegionStatus
Yuzuncu Yıl University Van Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07145398 on ClinicalTrials.gov ↗ ← All trials in Turkey