Epilepsy, GeneralizedNCT07540013
The Effect of Mandala Coloring on the Quality of Life in Epilepsy Patients: A Single Blind Randomized Controlled Study
A study testing Art therapy(Mandala) in people with Epilepsy, Generalized, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Generalized
- What is being tested?
- Art therapy(Mandala)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 13 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Refusal to participate in the study, Being 18 years of age or younger.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy, Generalized
- Being tested
- Art therapy(Mandala)
- Medical subject headings
- Epilepsy, Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group (epilepsy patients receiving art therapy) | Experimental | epilepsy patients receiving art therapy Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The "QQLI-31" was administered again at the 4th week (mid-point assessment) and the 8th week (post-test) of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 Apr 2025
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, GeneralizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYNUR CİN, Karadeniz Technical University
- Investigators
- AYNUR CIN, ASST. PROF. DR., Principal investigator, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540013
- Sponsor's protocol ID
- Gumushane University
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THE ETHICS COMMITTEE HAS NOT GRANTED APPROVAL
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring on Quality of Life in Patients With Epilepsy: A Single-Blind, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07540013
- Acronym / sponsor ID
- Gumushane University
- Conditions
- Epilepsy, Generalized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental group (epilepsy patients receiving art therapy) | Experimental | Other: Art therapy(Mandala)epilepsy patients receiving art therapy |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Refusal to participate in the study, Being 18 years of age or younger.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art therapy(Mandala)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. | Other | experimental group (epilepsy patients receiving art therapy) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No. THE ETHICS COMMITTEE HAS NOT GRANTED APPROVAL
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYNUR CIN, ASST. PROF. DR. principal investigator
Gümüşhane Universıty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art therapy(Mandala) in people with Epilepsy, Generalized, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.