Multiple SclerosisNCT06955962
Examining the Effect of Mandala Art Therapy on Symptoms and Quality of Life in Multiple Sclerosis Patients
A study testing Mandala Art Therapy in people with Multiple Sclerosis, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized controlled, pre-test-post-test experimental research aimed at examining the effects of mandala art therapy on symptom severity and quality of life in individuals diagnosed with Multiple Sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Mandala Art Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residing in the city center of Trabzon
- Diagnosed with Multiple Sclerosis at least six months prior
- Have not experienced an MS relapse within the past three months
- Receiving outpatient treatment for MS
- Literate
- Have no prior experience with mandala practice
- Not currently participating in any form of art therapy
- Have no communication or perception impairments
Who cannot join
- Those who have experienced an MS relapse within the past three months
- Those receiving inpatient treatment for MS
- Individuals aged 18 years or younger
- Those with a physical disability that prevents them from participating in the mandala activity
- Individuals currently engaged in any form of active art therapy
- Those with communication or perception impairments
Show all 9Show fewer
- Individuals with a diagnosed psychiatric disorder
- Those who cannot be reached via phone and/or text message
- Individuals with allergies to materials used in the mandala therapy sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study is a randomized controlled, pre-test-post-test experimental research aimed at examining the effects of mandala art therapy on symptom severity and quality of life in individuals diagnosed with Multiple Sclerosis (MS). The main goal is to determine whether mandala art therapy helps reduce the frequency and severity of MS symptoms while improving participants' overall quality of life.
It is expected that mandala art therapy will support MS patients in managing current and potential symptoms, coping more effectively with the disease, and improving adherence to treatment. As a result, a reduction in healthcare utilization, related costs, MS-related complications, and mortality is anticipated.
The study will be conducted between May and August 2025 at the Neurology Outpatient Clinic of Karadeniz Technical University Practice and Research Center, involving 70 patients-35 in the intervention group receiving mandala art therapy and 35 in the control group receiving standard care.
Read the detailed description
This study was designed as a randomized controlled, pre-test-post-test experimental research to examine the effects of mandala art therapy on symptom severity and quality of life in individuals diagnosed with Multiple Sclerosis (MS). The primary objective of the study is to evaluate whether the implementation of mandala art therapy contributes to a reduction in the frequency and severity of MS-related symptoms, while simultaneously enhancing the overall quality of life of the participants.
In this context, it is anticipated that mandala art therapy may support individuals with MS in managing existing and potential symptoms, coping more effectively with the disease, and achieving better adherence to treatment and disease management. Consequently, it is expected that the frequency of healthcare utilization and overall healthcare-related costs will decrease. Most importantly, a reduction in MS-related complications and mortality is also anticipated.
The planned study will be conducted between May 2025 and August 2025 at the Neurology Outpatient Clinic of the Karadeniz Technical University Practice and Research Center, involving a total of 70 patients-35 in the intervention group and 35 in the control group-who meet the inclusion criteria. While patients in the intervention group will receive mandala art therapy, those in the control group will continue their routine follow-up and treatment without any additional intervention.
- Conditions
- Multiple Sclerosis
- Being tested
- Mandala Art Therapy
- Keywords
- multiple sclerosis, mandala art therapy, quality of life
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala Art TherapyOther
Arm Description: The mandala art therapy for individuals in the intervention group is planned to be conducted in their home environments under suitable conditions. The therapy sessions will be accompanied by music of the participants' choosing and are scheduled to take place over a six-week period, at least three to four times per week, for a minimum of 30 minutes per session. Before the first mandala art therapy session, participants in the intervention group will receive a brief orientation by the researcher on the appropriate environment for the practice and an introduction to mandala art therapy. This orientation will include information on the definition and characteristics of mandala art therapy, the application setting and duration, and general guidelines to be followed during the sessions. At the end of the six-week mandala art therapy program, Post-tests ill be administered face-to-face, and the archived mandala folders will be collected
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | In the study, no intervention will be applied to individuals in the control group during their visits to the neurology outpatient clinic; they will continue with their routine follow-up, examinations, and treatment as usual. Pre-tests will be administered to participants in the control group who agree to take part in the study, have been informed about its purpose, scope, duration, and methodology, and have provided both written and verbal consent. These pre-tests will include the "Descriptive Information Form," the "Multiple Sclerosis Symptom Scale (MS-RS)," and the "Multiple Sclerosis Quality of Life Scale (MSQL-54)." At the end of six weeks, participants will be contacted via telephone to schedule an appointment for the administration of post-tests. The post-tests to be applied to the control group will again include the "Descriptive Information Form," the "Multiple Sclerosis Symptom Scale (MS-RS)," and the "Multiple Sclerosis Quality of Life Scale (MSQL-54)." |
| Intervention Group | Experimental | The mandala art therapy for individuals in the intervention group is planned to be conducted in their home environments under suitable conditions. The therapy sessions will be accompanied by music of the participants' choosing and are scheduled to take place over a six-week period, at least three to four times per week, for a minimum of 30 minutes per session. Receives: Other: Mandala Art Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life of patient with MS
The quality of life of patient with MS will be defined by using Multiple Sclerosis Quality of Life Scale (MSQL-54).
The scale scores range from 0 to 100, and as the score increases, the quality of life of individuals increases.
Measured: 6 week
Secondary outcomes (1)
Symptom evaluation of patient with MS
Symptom evaluation of patient with MS will be defined by using Multiple Sclerosis Symptom Scale (MS-RS) The minimum score that can be obtained from the scale is 0, the maximum score is 130, with higher scores indicating increased symptom burden.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start10 May 2025 (estimated)
- Primary completion10 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- The mandala art therapy for individuals in the intervention group is planned to be conducted in their home environments under suitable conditions. The therapy sessions will be accompanied by music of the participants' choosing and are scheduled to take place over a six-week period, at least three to four times per week, for a minimum of 30 minutes per session.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Müge TEZEL, Karadeniz Technical University
- Investigators
- Nesrin NURAL, Prof, Study director, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955962
- Sponsor's protocol ID
- MTEZEL
- Status last verified
- Mar 2025
- First submitted
- 11 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This thesis study is currently ongoing and has not yet been completed.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Mandala Art Therapy on Symptoms and Quality of Life in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT06955962
- Acronym / sponsor ID
- MTEZEL
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, mandala art therapy, quality of life
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 10 May 2025 (estimated)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 2 May 2025 (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.
This study is a randomized controlled, pre-test-post-test experimental research aimed at examining the effects of mandala art therapy on symptom severity and quality of life in individuals diagnosed with Multiple Sclerosis (MS). The main goal is to determine whether mandala art therapy helps reduce the frequency and severity of MS symptoms while improving participants' overall quality of life.
It is expected that mandala art therapy will support MS patients in managing current and potential symptoms, coping more effectively with the disease, and improving adherence to treatment. As a result, a reduction in healthcare utilization, related costs, MS-related complications, and mortality is anticipated.
The study will be conducted between May and August 2025 at the Neurology Outpatient Clinic of Karadeniz Technical University Practice and Research Center, involving 70 patients-35 in the intervention group receiving mandala art therapy and 35 in the control group receiving standard care.
Detailed description
This study was designed as a randomized controlled, pre-test-post-test experimental research to examine the effects of mandala art therapy on symptom severity and quality of life in individuals diagnosed with Multiple Sclerosis (MS). The primary objective of the study is to evaluate whether the implementation of mandala art therapy contributes to a reduction in the frequency and severity of MS-related symptoms, while simultaneously enhancing the overall quality of life of the participants.
In this context, it is anticipated that mandala art therapy may support individuals with MS in managing existing and potential symptoms, coping more effectively with the disease, and achieving better adherence to treatment and disease management. Consequently, it is expected that the frequency of healthcare utilization and overall healthcare-related costs will decrease. Most importantly, a reduction in MS-related complications and mortality is also anticipated.
The planned study will be conducted between May 2025 and August 2025 at the Neurology Outpatient Clinic of the Karadeniz Technical University Practice and Research Center, involving a total of 70 patients-35 in the intervention group and 35 in the control group-who meet the inclusion criteria. While patients in the intervention group will receive mandala art therapy, those in the control group will continue their routine follow-up and treatment without any additional intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The mandala art therapy for individuals in the intervention group is planned to be conducted in their home environments under suitable conditions. The therapy sessions will be accompanied by music of the participants' choosing and are scheduled to take place over a six-week period, at least three to four times per week, for a minimum of 30 minutes per session.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –In the study, no intervention will be applied to individuals in the control group during their visits to the neurology outpatient clinic; they will continue with their routine follow-up, examinations, and treatment as usual. Pre-tests will be administered to participants in the control group who agree to take part in the study, have been informed about its purpose, scope, duration, and methodology, and have provided both written and verbal consent. These pre-tests will include the "Descriptive Information Form," the "Multiple Sclerosis Symptom Scale (MS-RS)," and the "Multiple Sclerosis Quality of Life Scale (MSQL-54)." At the end of six weeks, participants will be contacted via telephone to schedule an appointment for the administration of post-tests. The post-tests to be applied to the control group will again include the "Descriptive Information Form," the "Multiple Sclerosis Symptom Scale (MS-RS)," and the "Multiple Sclerosis Quality of Life Scale (MSQL-54)." |
| Intervention Group | Experimental | Other: Mandala Art TherapyThe mandala art therapy for individuals in the intervention group is planned to be conducted in their home environments under suitable conditions. The therapy sessions will be accompanied by music of the participants' choosing and are scheduled to take place over a six-week period, at least three to four times per week, for a minimum of 30 minutes per session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Residing in the city center of Trabzon
- Diagnosed with Multiple Sclerosis at least six months prior
- Have not experienced an MS relapse within the past three months
- Receiving outpatient treatment for MS
- Literate
Key exclusion criteria (9 listed)
- Those who have experienced an MS relapse within the past three months
- Those receiving inpatient treatment for MS
- Individuals aged 18 years or younger
- Those with a physical disability that prevents them from participating in the mandala activity
- Individuals currently engaged in any form of active art therapy
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 |
|---|---|---|
| Mandala Art TherapyArm Description: The mandala art therapy for individuals in the intervention group is planned to be conducted in their home environments under suitable conditions. The therapy sessions will be accompanied by music of the participants' choosing and are scheduled to take place over a six-week period, at least three to four times per week, for a minimum of 30 minutes per session. Before the first mandala art therapy session, participants in the intervention group will receive a brief orientation by the researcher on the appropriate environment for the practice and an introduction to mandala art therapy. This orientation will include information on the definition and characteristics of mandala art therapy, the application setting and duration, and general guidelines to be followed during the sessions. At the end of the six-week mandala art therapy program, Post-tests ill be administered face-to-face, and the archived mandala folders will be collected | Other | Intervention Group |
Primary outcome
Quality of life of patient with MS
Time frame: 6 week
The quality of life of patient with MS will be defined by using Multiple Sclerosis Quality of Life Scale (MSQL-54). The scale scores range from 0 to 100, and as the score increases, the quality of life of individuals increases.
1 secondary outcome
Symptom evaluation of patient with MS
Time frame: 6 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No. This thesis study is currently ongoing and has not yet been completed.
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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.
Nesrin NURAL, Prof study director
Karadeniz Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala Art Therapy in people with Multiple Sclerosis, 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 8 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 9 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Quality of life of patient with MS (time frame: 6 week). 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 9 May 2025.