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

April 13, 2026 updated by: AYNUR CİN, Karadeniz Technical University

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Epilepsy is one of the most common serious brain disorders. It affects more than 70 million people worldwide, particularly infants and the elderly, who are among the high-risk groups (Thijs et al., 2019). Epilepsy is a disease that can occur regardless of race, age, or gender, and approximately five million people are diagnosed with it each year [World Health Organization (WHO), 2019]. It is also defined as a chronic neurological disorder characterized by recurrent, spontaneous, and unpredictable seizures (Kobylarek et al., 2019), and is sometimes accompanied by loss of consciousness and loss of control over bowel and bladder functions (WHO, 2022). In this disease, which develops due to impaired sensitivity of neurons in the cerebral cortex and limbic centers, seizures do not occur spontaneously and are specific to the condition (Karadakovan and Aslan, 2020). In epilepsy, seizures may involve loss of consciousness, staring fixedly at a point (staring spells), blinking, sudden body spasms, uncontrollable tremors or stiffness in the limbs, smacking of the lips, rapid and rhythmic head shaking, psychological symptoms (anxiety, fear, etc.), and an inability to respond immediately to sounds or words (Pack, 2019). However, the diagnosis of the disease is made by a physician following a neurological examination of the clinical presentation, along with imaging methods and laboratory tests [Turkish Neurological Society (TND), 2021].

Epilepsy is a condition that has been known for over a century; despite advances in diagnosis and treatment, it continues to negatively impact patients' quality of life today (Kırca, 2020). Furthermore, due to its association with morbidity, mortality, stigma, and its presence in the health histories of communities worldwide, it is a significant condition that affects quality of life. Furthermore, due to its social, cultural, psychological, and economic consequences, this condition constitutes a public health issue (Mollaoğlu et al., 2015).

Effective treatment of epilepsy requires the appropriate use of antiepileptic medications, alongside counseling, education, cognitive-behavioral therapy, and social support provided to the patient and their family (Karaca and Durna, 2018). Ensuring the patient's protection from injury during a seizure, maintaining mental and physical functioning at the highest possible level, and preserving psychosocial functioning are among the goals of nursing care (Karabulutlu and Turan, 2022). Epilepsy is a neurological disorder that negatively impacts a person's quality of life and causes significant limitations in their physical, social, emotional, and intellectual lives (Kırca, 2020). Epilepsy patients, who must continue their lives despite seizures that disrupt family structures and evoke feelings of helplessness and inadequacy in patients, face significant challenges. This situation diminishes the self-esteem and quality of life of people with epilepsy (Erdoğan, 2021).Personalized nursing care can also improve patients' quality of life (Coşar & Dayapoğlu, 2020). In this context, it is necessary to utilize art-based interventions, which have positive effects on quality of life and are significant for health promotion and prevention in the healthcare sector (Bostancıoğlu & Kahraman, 2017). Personalized nursing care can also improve patients' quality of life (Coşar, Dayapoğlu, 2020). In this context, art therapy has positive effects on quality of life and plays a significant role in health promotion and prevention within the healthcare sector Although there are various studies in the literature on the effects of art therapy on quality of life in different diseases, such as anxiety (Bosman et al., 2021; Jiang et al., 2020), no study has been found that investigates the effect of mandala art therapy on quality of life in patients with epilepsy. Based on this information, this randomized controlled study aims to determine the effect of mandala coloring on quality of life in patients with epilepsy.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group (epilepsy patients receiving art therapy)
epilepsy patients receiving art therapy
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.
No Intervention: control group (epilepsy patients)
For patients in the control group, no therapy was administered; instead, data collection tools were applied simultaneously with the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life in Epilepsy (QOLIE-31) Score.
Time Frame: The "QQLI-31" was administered again at the 4th week (mid-point assessment) and the 8th week (post-test) of the study.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: AYNUR CIN, ASST. PROF. DR., Gümüşhane Universıty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Actual)

April 13, 2026

Study Completion (Actual)

April 13, 2026

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Gumushane University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

THE ETHICS COMMITTEE HAS NOT GRANTED APPROVAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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