The Effect of Mandala Coloring on the Quality of Life in Epilepsy Patients: A Single Blind Randomized Controlled Study

NCT07540013 | Completed

• 1 other identifier: Gumushane University
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Epilepsy is among the most prevalent and serious neurological disorders. While antiepileptic medications play a crucial role in managing the condition, additional support through counseling, education, cognitive behavioral therapy, and social assistance for both patients and their families is essential. Furthermore, incorporating art-based interventions is vital due to their beneficial effects on life quality and their significance in health promotion and prevention. Research suggests that art therapy can aid patients in managing their symptoms and enhancing their overall well-being. Currently, mandalas are being effectively utilized in art therapy practices. However, a review of the literature reveals a lack of studies examining the impact of mandala art therapy on the quality of life for individuals with epilepsy. This randomized controlled trial aims to assess how mandala painting influences the quality of life in epilepsy patients. The study will involve adult epilepsy patients from Gümüşhane State Hospital Neurology Polyclinic. Participants will be randomly assigned to either a control group or an experimental group using a lottery method, known as "Full (Simple) Randomization." Data will be gathered through a patient information form and the "Quality of Life Scale in Epilepsy (QOLIE-31)." The experimental group will receive materials for mandala painting and will be instructed to complete one mandala at home three times a week over the course of twenty-four sessions (two months), with each session lasting approximately 30 minutes. All participants will undergo the "Patient Information Form" and "QQLI-31" assessment prior to the study (pre-test), with the "QQLI-31" reassessed in the 4th week (intermediate measurement) and again in the 8th week (post-test). The results will be analyzed to determine the impact of mandala therapy on the quality of life in epilepsy patients.

Conditions

Epilepsy, Generalized

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life in Epilepsy (QOLIE-31) Score.

  The QOLIE-31 is a survey of health-related quality of life for adults with epilepsy. It evaluates domains such as seizure worry, overall quality of life, emotional well-being, energy/fatigue, cognitive functioning, medication effects, and social functioning. Scores range from 0 to 100, where higher scores indicate a better quality of life.

  The "QQLI-31" was administered again at the 4th week (mid-point assessment) and the 8th week (post-test) of the study.

Study Arms (2)

experimental group (epilepsy patients receiving art therapy)

EXPERIMENTAL

epilepsy patients receiving art therapy

Other: Art therapy(Mandala)

control group (epilepsy patients)

NO INTERVENTION

For patients in the control group, no therapy was administered; instead, data collection tools were applied simultaneously with the experimental group.

Interventions

Art therapy(Mandala) OTHER

To ensure single-blind randomization and prevent bias, another researcher will provide training on mandala coloring and show a video to the participants before the study begins. After the first session was conducted together, mandala coloring materials were provided to the patients, and they were asked to color one mandala figure per session, lasting approximately 30 minutes, for a total of twenty-four (2-month) sessions over three days a week at the hospital. Prior to the start of the study (pre-test), the "Patient Information Form" and "QQLI-31" were administered to all patient groups; the "QQLI-31" was administered again at the 4th week (mid-point assessment) and the 8th week (post-test) of the study. After the study's implementation phase concluded, mandala drawing materials were gifted to epilepsy patients who wished to receive them.

experimental group (epilepsy patients receiving art therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age, Agree to participate in the study, Possess the cognitive ability to answer the questions, Have been diagnosed with epilepsy at least 6 months prior, Not having used techniques such as meditation, hypnosis, or yoga within the 6-month period prior to the study, Not having any other neurological, systemic, or psychiatric conditions besides epilepsy, No motor function impairments that would prevent mandala coloring.

You may not qualify if:

• Refusal to participate in the study, Being 18 years of age or younger.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Kelkit State Hospital

Gümüşhane, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Epilepsy, Generalized

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• AYNUR CIN, ASST. PROF. DR.

  Gümüşhane Universıty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To ensure single-blind randomization and prevent bias, another researcher will provide training on mandala coloring and show a video to the participants before the study begins.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASST. PROF. DR.

Model Details: To ensure single-blind randomization and prevent bias, another researcher will provide training on mandala coloring and show a video to the participants before the study begins. After the first session is conducted together, mandala coloring materials will be provided to the patients, and they will be asked to color one mandala figure per session, lasting approximately 30 minutes, for a total of twenty-four (2-month) sessions over three days a week at the hospital. Prior to the start of the study (pre-test), the "Patient Information Form" and "QQLI-31" will be administered to all patient groups. The "QQLI-31" will also be administered during the 4th week of the study (mid-term assessment) and the 8th week of the study (post-test). After the study's implementation phase concludes, mandala drawing materials will be gifted to epilepsy patients who wish to receive them.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 15, 2025
• Primary Completion: April 13, 2026
• Study Completion: April 13, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)