- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07540013
The Effect of Mandala Coloring on the Quality of Life in Epilepsy Patients: A Single Blind Randomized Controlled Study
The Effect of Mandala Coloring on Quality of Life in Patients With Epilepsy: A Single-Blind, Randomized, Controlled Study
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gümüşhane, Turkey (Türkiye)
- Kelkit State Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
|---|---|
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Experimental: experimental group (epilepsy patients receiving art therapy)
epilepsy patients receiving art therapy
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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The "QQLI-31" was administered again at the 4th week (mid-point assessment) and the 8th week (post-test) of the study.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: AYNUR CIN, ASST. PROF. DR., Gümüşhane Universıty
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gumushane University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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