An interventional study of Art therapy(Mandala) in Epilepsy, Generalized, sponsored by Karadeniz Technical University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Karadeniz Technical University · Not applicable, Interventional, and Supportive care
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.
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.
39 studies on the registry are indexed under Epilepsy, Generalized; 4 are open to participants now.
This study's enrollment of 70 is close to the median of 75 across 25 interventional studies indexed under Epilepsy, Generalized.
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Exclusion Criteria:
epilepsy patients receiving art therapy
Other: Art therapy(Mandala)
For patients in the control group, no therapy was administered; instead, data collection tools were applied simultaneously with the experimental group.
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.
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.
Time frame: The "QQLI-31" was administered again at the 4th week (mid-point assessment) and the 8th week (post-test) of the study.
Plan to share: No — THE ETHICS COMMITTEE HAS NOT GRANTED APPROVAL
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Ran from Apr 2025 to primary completion in Apr 2026, 11 months.
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