Parent-Child Mandala Painting During Chemotherapy

NCT07363005 | Completed

• 1 other identifier: YYU-MANDALA-ONCO-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effects of a parent-child mandala painting intervention conducted during the chemotherapy process on caregiver burden, psychological well-being, and child fear and pain levels in pediatric oncology patients. Childhood cancer and its treatment are highly stressful experiences for both children and their parents. Chemotherapy-related side effects such as pain, fear, and emotional distress may negatively affect children's psychological well-being and treatment adaptation. Parents, as primary caregivers, often experience increased emotional burden, anxiety, and stress during this process. The intervention consists of a structured parent-child mandala painting activity delivered over a two-week period, with six sessions in total, each lasting 30 minutes. Participants are randomly assigned to either the intervention group, which receives the mandala painting activity in addition to routine care, or the control group, which receives routine nursing care alone. Outcome measures include child fear and pain levels assessed using validated pediatric scales, as well as caregiver burden and psychological distress measured through standardized questionnaires. Assessments are conducted at baseline and after completion of the two-week intervention period. This study seeks to contribute evidence on the use of creative, non-pharmacological interventions to support emotional well-being in children undergoing chemotherapy and their caregivers.

Conditions

Childhood Cancers; Pediatric Oncology

Keywords

Mandala painting; Art therapy; Pediatric chemotherapy; Caregiver burden; Child fear; Pain management; Non-pharmacological intervention; Parent-child interaction

Outcome Measures

Primary Outcomes (2)

• Children's Pain Level

  Change in children's pain level measured using the Wong-Baker Faces Pain Rating Scale (WBFPRS), a validated pediatric pain assessment tool consisting of six facial expressions representing increasing pain intensity. The scale is scored from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Higher scores represent greater pain intensity.

  Baseline and at the end of the 2-week intervention period

• Children's Fear Level

  Change in children's fear level measured using the Children's Fear Scale (CFS), a single-item observational scale designed to assess fear in children. The scale ranges from 0 to 4, where 0 represents "no fear" and 4 represents "extreme fear." Higher scores indicate higher levels of fear.

  Baseline and at the end of the 2-week intervention period

Secondary Outcomes (2)

• Caregiver Burden

  Baseline and at the end of the 2-week intervention period

• Parental Psychological Distress

  Baseline and at the end of the 2-week intervention period

Study Arms (2)

Mandala Painting Group

EXPERIMENTAL

Participants in this arm receive a structured parent-child mandala painting intervention in addition to routine nursing care during the chemotherapy process. The intervention is delivered over two weeks, consisting of six sessions, each lasting approximately 30 minutes.

Behavioral: Parent-Child Mandala Painting Intervention

Control Group

NO INTERVENTION

Participants in this arm receive routine nursing care during the chemotherapy process without any additional structured intervention during the study period.

Interventions

Parent-Child Mandala Painting Intervention BEHAVIORAL

This behavioral intervention involves structured parent-child mandala painting sessions conducted during the chemotherapy process. The intervention aims to support children's emotional well-being and fine motor skills while enhancing parent-child interaction. Sessions are delivered over a two-week period, with a total of six sessions, each lasting approximately 30 minutes, and are facilitated by a trained nurse.

Mandala Painting Group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 5 and 12 years who are receiving chemotherapy.
• One parent or primary caregiver willing to participate with the child.
• Ability of the child to perform basic fine motor activities such as holding a pencil and coloring.
• Absence of an acute psychiatric diagnosis in the child (e.g., severe anxiety disorder, psychotic disorders).
• Willingness of both the child and the parent to participate in the study.

You may not qualify if:

• Children diagnosed with stage III or stage IV cancer.
• Presence of visual perception impairments in the child (e.g., color blindness, severe visual impairment).
• Refusal of the child or parent to participate in the study.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University Dursun Odabas Medical Center

Van, Turkey, 65090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver Burden; Agnosia

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: Assist. Prof. (PhD)

Model Details: Participants are randomly assigned to either an intervention group receiving a parent-child mandala painting activity in addition to routine care or a control group receiving routine care alone.

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: November 22, 2025
• Primary Completion: March 25, 2026
• Study Completion: March 25, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)