Elderly PersonsMANDALANCT07145853
Mandala for Anxiety, Fatigue, and Sleep
A study testing Mandala activity in people with Elderly Persons, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Looking at the studies on social activity programs in individuals living in nursing homes in the literature, it was seen that the studies on Mandala therapy were limited. In this study, it is aimed to examine the effect of Mandala application, known as art therapy, on anxiety, fatigue and sleep quality in individuals… Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly Persons
- What is being tested?
- Mandala activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2025to 12 Nov 2025
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- • Individuals aged 65 years and older with a score of 24 and above on the Mini Mental State Examination
- Ability to use/hold a pen
- Individuals without allergies,
Who cannot join
- Unable to communicate verbally
- Unable to act independently,
- Severe vision loss,
- People with neurological diseases such as stroke, Parkinson's, multiple sclerosis, dementia, etc,
- Has undergone any operation in the last six months,
- Individuals aged 65 and over diagnosed with cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences, Marmara University
Istanbul, Maltepe, 34854
About this study
Official title: "The Effect of Mandala Activity on Anxiety, Fatigue and Sleep Quality of Elderly Individuals Staying in a Nursing Home"
Looking at the studies on social activity programs in individuals living in nursing homes in the literature, it was seen that the studies on Mandala therapy were limited. In this study, it is aimed to examine the effect of Mandala application, known as art therapy, on anxiety, fatigue and sleep quality in individuals living in nursing homes.
Read the detailed description
In the world and in our country, the elderly population is increasing day by day. The average human life span is increasing as a result of the decrease in newborn rates, early diagnosis and treatment of chronic diseases due to developments in the field of medicine and technology, prevention of infectious diseases, increase in welfare level, increase in the level of education and health literacy of the society. The United Nations World Population Prospects 2022 report predicts that the number of individuals aged 65 and over will increase from 10% in 2022 to 16% in 2050. In Turkey, according to the Turkish Statistical Institute Statistics on the Elderly 2022 data, the proportion of the elderly population in the total population increased from 8.5% in 2017 to 9.9% in 2022. According to population projections, TÜİK predicts that the proportion of elderly population in Turkey will increase to 12.9% in 2030 and 16.3% in 2040.
Due to the increase in the elderly population, the care of the elderly population comes to the forefront as an important public health problem. With old age, which is an inevitable process, physiological, psychological, economic and social changes occur in individuals and adaptation problems are observed in individuals. Health care services of the elderly population is an important situation that requires a wide range of approaches. With old age, which is the last stage of life, there is a decrease in physical abilities, cognitive functions and activities of daily living. The elderly individual becomes more dependent on the environment as time passes. Due to the physiological changes brought about by old age, the risk of developing diseases increases. Many systems such as cardiovascular system, musculoskeletal system, gastrointestinal system, neuro-psychiatric system are affected in the elderly. Disability and disability increase in elderly individuals and therefore their quality of life deteriorates due to inadequacies in performing daily life activities.
Chronic diseases that occur due to aging make it more difficult for individuals to provide care for themselves. Care services for the elderly in need of care are provided formally and informally. Formal care is a set of professional care services provided by public/private institutions and organizations, while informal care is voluntary care provided by family, close relatives, neighbors or friends. In recent years, social changes due to many factors such as industrialization, modernization and urbanization affect the position of the elderly in society. Migrations from rural to urban areas, shrinking houses and increase in the rate of nuclear family, economic problems, increase in the employment rate of women, etc. Many factors cause problems in home care for the elderly. Elderly individuals who cannot find a place for themselves in the nuclear family may have to live alone or settle in public/private institutions or organizations such as nursing homes and move away from the environment and people they are used to.
Failure to address the psychological and social aspects holistically due to more emphasis on physical care in formal care leads to deterioration of cognitive functions in elderly individuals and difficulty in performing daily living activities. In addition, elderly people who are placed in institutions such as nursing homes may experience feelings such as isolation and feeling worthless due to the change in the environment and people who determine self-acceptance and respect. In old age, deterioration of the social support system consisting of spouse, family and friends, all kinds of losses, indifference, accepting old age as the last stage of life and additional diseases negatively affect psychological health. For these reasons, many psychological problems such as depression, anxiety, dementia, delirium and insomnia can be seen in the elderly. Social support is very important in coping with these problems.
Anxiety, fatigue and sleep quality are among the most important reasons that impair the functionality of elderly individuals and reduce their quality of life. It has been reported that living alone is an important risk factor for depression and suicide. This effect of living alone can be overcome with a social support system. Considering the prevalence of anxiety disorders in old age, it has been reported that the prevalence is between 14.2-29.4%. In a study conducted by Kırmızıoğlu et al. (2009) on elderly individuals in our country, general anxiety disorder was found to be 6.9% in this group.Risk factors associated with anxiety disorders include being female, being single, low education level, negative life events, comorbidities and childhood traumas.
In addition to physical, physiological and mental processes with aging, individuals' sleep quality and fatigue levels are affected as a result of lifestyle changes in the nursing home. In the systematic review study of Doris et al. it was reported that 27-50% of the elderly experienced moderate or severe fatigue. Sleep problems are increasing due to the aging process, and elderly individuals experience many conditions such as sleep quality, duration, continuity, and delay in sleep onset. The prevalence of sleep disorders in elderly individuals varies between 41.9% and 77%.
Nursing homes play a key role in the management of symptoms such as anxiety, fatigue and sleep quality in the elderly when social support cannot be provided by family and friends. This key role is made possible by providing social activity programs, meeting their psychological needs and housing in a healthy environment. In order for individuals living in nursing homes to participate more actively in life; work-oriented activities (handicraft, gardening, painting, wood painting), food activities (cooking, birthdays, tea time, etc.), exercise, cognitive therapies (cognitive stimulation therapies, reminiscence, etc.), music therapy, outdoor activities, prayer therapy and computer-aided activities can be done. These activity programs applied to the elderly improve the quality of life of the elderly. Cost-effective, therapeutic, non-pharmacological nursing interventions are needed to improve the quality of life of elderly individuals staying in nursing homes. Mandala is a Sanskrit term meaning circle or center, originating in India. Mandala is usually in the shape of a circle or square and is a painting method that allows transferring emotions and thoughts to paper. This activity is a colorful activity that can lead to problem solving. 'Manda' means energy or essence and 'La' means container. Mandala means a round container that holds or stores energy.Drawing a mandala starts by identifying a center point. There is always a human in the center. The picture or image created by the mandala is a reflection of the individual's current mood and self. Mandala painting is a psychotherapy technique that provides psychological support and healing.
Looking at the studies on social activity programs in individuals living in nursing homes in the literature, it was seen that the studies on Mandala therapy were limited. In this study, it is aimed to examine the effect of Mandala application, known as art therapy, on anxiety, fatigue and sleep quality in individuals living in nursing homes.
- Conditions
- Elderly Persons
- Being tested
- Mandala activity
- Keywords
- art therapy, Nursing Homes, Anxiety, fatigue, Sleep Quality
- Medical subject headings
- Anxiety Disorders, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala activityOther
The application will last for 1-2 hours once a week for a total of 8 weeks.
For individuals aged 65 years and over who meet the inclusion criteria and are included in the intervention group, a mandala draft in A4 format (21.0 cm x 29.7 cm) consisting of 8 round patterns to be determined in advance, and a dry paint set consisting of 12 colors for ease of use will be used. Quality dry paint will be used to prevent allergies
| Study group | Role | What they receive |
|---|---|---|
| Mandala activity group | Experimental | The application will last for 1-2 hours once a week for a total of 8 weeks.
For individuals aged 65 years and over who meet the inclusion criteria and are included in the intervention group, a mandala draft in A4 format (21.0 cm x 29.7 cm) consisting of 8 round patterns to be determined in advance, and a dry paint set consisting of 12 colors for ease of use will be used. Quality dry paint will be used to prevent allergies Receives: Other: Mandala activity |
| Control Group | No intervention | No intervention will be applied to the control group. The dry paint and mandala drafts necessary to overcome the deprivation of the control group will be left for them to do the activity after the study is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Score Measured by the Geriatric Anxiety Scale (GAS) [Score Range: 0-75]
Anxiety will be assessed using the Geriatric Anxiety Scale (GAS). The scale consists of 23 items scored from 0 to 3, with a total score ranging from 0 to 75. Higher scores indicate higher levels of anxiety.
Measured: Baseline and 8 weeks
Secondary outcomes (1)
Change in Fatigue Severity Measured by the Fatigue Severity Scale (FSS) [Score Range: 9-63]
Fatigue will be assessed using the Fatigue Severity Scale (FSS), a 9-item self-report measure rated from 1 to 7. Total scores range from 9 to 63, with higher scores representing more severe fatigue.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start30 May 2025
- Primary completion14 Aug 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PersonsStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Individuals included in the study will be randomized from the random.org website. Data will be collected twice in the intervention and control groups as pre-test and post-test. The pre-test of the study will be administered between May 2025-Septemb2025 and the post-test will be administered to individuals who completed the 8-week mandala activity in the intervention group. The descriptive questionnaire (Appendix-1) will not be applied in the post-test since the variables to be applied in the pre-test are fixed. Mandala activity will be applied to the intervention group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can Lafci, Marmara University
- Investigators
- Can LAFÇI, PhDc, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145853
- Sponsor's protocol ID
- MarmaraU-HB-CL-34
- Acronym
- MANDALA
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "IPD will not be shared because of ethical and privacy considerations related to the vulnerable elderly population residing in a nursing home."
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Mandala Activity on Anxiety, Fatigue and Sleep Quality of Elderly Individuals Staying in a Nursing Home"
- ClinicalTrials.gov ID
- NCT07145853
- Acronym / sponsor ID
- MANDALA / MarmaraU-HB-CL-34
- Conditions
- Elderly Persons
- Keywords
- art therapy, Nursing Homes, Anxiety, fatigue, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 28 Aug 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.
Looking at the studies on social activity programs in individuals living in nursing homes in the literature, it was seen that the studies on Mandala therapy were limited. In this study, it is aimed to examine the effect of Mandala application, known as art therapy, on anxiety, fatigue and sleep quality in individuals living in nursing homes.
Detailed description
In the world and in our country, the elderly population is increasing day by day. The average human life span is increasing as a result of the decrease in newborn rates, early diagnosis and treatment of chronic diseases due to developments in the field of medicine and technology, prevention of infectious diseases, increase in welfare level, increase in the level of education and health literacy of the society. The United Nations World Population Prospects 2022 report predicts that the number of individuals aged 65 and over will increase from 10% in 2022 to 16% in 2050. In Turkey, according to the Turkish Statistical Institute Statistics on the Elderly 2022 data, the proportion of the elderly population in the total population increased from 8.5% in 2017 to 9.9% in 2022. According to population projections, TÜİK predicts that the proportion of elderly population in Turkey will increase to 12.9% in 2030 and 16.3% in 2040.
Due to the increase in the elderly population, the care of the elderly population comes to the forefront as an important public health problem. With old age, which is an inevitable process, physiological, psychological, economic and social changes occur in individuals and adaptation problems are observed in individuals. Health care services of the elderly population is an important situation that requires a wide range of approaches. With old age, which is the last stage of life, there is a decrease in physical abilities, cognitive functions and activities of daily living. The elderly individual becomes more dependent on the environment as time passes. Due to the physiological changes brought about by old age, the risk of developing diseases increases. Many systems such as cardiovascular system, musculoskeletal system, gastrointestinal system, neuro-psychiatric system are affected in the elderly. Disability and disability increase in elderly individuals and therefore their quality of life deteriorates due to inadequacies in performing daily life activities.
Chronic diseases that occur due to aging make it more difficult for individuals to provide care for themselves. Care services for the elderly in need of care are provided formally and informally. Formal care is a set of professional care services provided by public/private institutions and organizations, while informal care is voluntary care provided by family, close relatives, neighbors or friends. In recent years, social changes due to many factors such as industrialization, modernization and urbanization affect the position of the elderly in society. Migrations from rural to urban areas, shrinking houses and increase in the rate of nuclear family, economic problems, increase in the employment rate of women, etc. Many factors cause problems in home care for the elderly. Elderly individuals who cannot find a place for themselves in the nuclear family may have to live alone or settle in public/private institutions or organizations such as nursing homes and move away from the environment and people they are used to.
Failure to address the psychological and social aspects holistically due to more emphasis on physical care in formal care leads to deterioration of cognitive functions in elderly individuals and difficulty in performing daily living activities. In addition, elderly people who are placed in institutions such as nursing homes may experience feelings such as isolation and feeling worthless due to the change in the environment and people who determine self-acceptance and respect. In old age, deterioration of the social support system consisting of spouse, family and friends, all kinds of losses, indifference, accepting old age as the last stage of life and additional diseases negatively affect psychological health. For these reasons, many psychological problems such as depression, anxiety, dementia, delirium and insomnia can be seen in the elderly. Social support is very important in coping with these problems.
Anxiety, fatigue and sleep quality are among the most important reasons that impair the functionality of elderly individuals and reduce their quality of life. It has been reported that living alone is an important risk factor for depression and suicide. This effect of living alone can be overcome with a social support system. Considering the prevalence of anxiety disorders in old age, it has been reported that the prevalence is between 14.2-29.4%. In a study conducted by Kırmızıoğlu et al. (2009) on elderly individuals in our country, general anxiety disorder was found to be 6.9% in this group.Risk factors associated with anxiety disorders include being female, being single, low education level, negative life events, comorbidities and childhood traumas.
In addition to physical, physiological and mental processes with aging, individuals' sleep quality and fatigue levels are affected as a result of lifestyle changes in the nursing home. In the systematic review study of Doris et al. it was reported that 27-50% of the elderly experienced moderate or severe fatigue. Sleep problems are increasing due to the aging process, and elderly individuals experience many conditions such as sleep quality, duration, continuity, and delay in sleep onset. The prevalence of sleep disorders in elderly individuals varies between 41.9% and 77%.
Nursing homes play a key role in the management of symptoms such as anxiety, fatigue and sleep quality in the elderly when social support cannot be provided by family and friends. This key role is made possible by providing social activity programs, meeting their psychological needs and housing in a healthy environment. In order for individuals living in nursing homes to participate more actively in life; work-oriented activities (handicraft, gardening, painting, wood painting), food activities (cooking, birthdays, tea time, etc.), exercise, cognitive therapies (cognitive stimulation therapies, reminiscence, etc.), music therapy, outdoor activities, prayer therapy and computer-aided activities can be done. These activity programs applied to the elderly improve the quality of life of the elderly. Cost-effective, therapeutic, non-pharmacological nursing interventions are needed to improve the quality of life of elderly individuals staying in nursing homes. Mandala is a Sanskrit term meaning circle or center, originating in India. Mandala is usually in the shape of a circle or square and is a painting method that allows transferring emotions and thoughts to paper. This activity is a colorful activity that can lead to problem solving. 'Manda' means energy or essence and 'La' means container. Mandala means a round container that holds or stores energy.Drawing a mandala starts by identifying a center point. There is always a human in the center. The picture or image created by the mandala is a reflection of the individual's current mood and self. Mandala painting is a psychotherapy technique that provides psychological support and healing.
Looking at the studies on social activity programs in individuals living in nursing homes in the literature, it was seen that the studies on Mandala therapy were limited. In this study, it is aimed to examine the effect of Mandala application, known as art therapy, on anxiety, fatigue and sleep quality in individuals living in nursing homes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Individuals included in the study will be randomized from the random.org website. Data will be collected twice in the intervention and control groups as pre-test and post-test. The pre-test of the study will be administered between May 2025-Septemb2025 and the post-test will be administered to individuals who completed the 8-week mandala activity in the intervention group. The descriptive questionnaire (Appendix-1) will not be applied in the post-test since the variables to be applied in the pre-test are fixed. Mandala activity will be applied to the intervention group.
| Arm | Type | Receives |
|---|---|---|
| Mandala activity group | Experimental | Other: Mandala activityThe application will last for 1-2 hours once a week for a total of 8 weeks. For individuals aged 65 years and over who meet the inclusion criteria and are included in the intervention group, a mandala draft in A4 format (21.0 cm x 29.7 cm) consisting of 8 round patterns to be determined in advance, and a dry paint set consisting of 12 colors for ease of use will be used. Quality dry paint will be used to prevent allergies |
| Control Group | No intervention | –No intervention will be applied to the control group. The dry paint and mandala drafts necessary to overcome the deprivation of the control group will be left for them to do the activity after the study is completed. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- • Individuals aged 65 years and older with a score of 24 and above on the Mini Mental State Examination
Key exclusion criteria (6 listed)
- Unable to communicate verbally
- Unable to act independently,
- Severe vision loss,
- People with neurological diseases such as stroke, Parkinson's, multiple sclerosis, dementia, etc,
- Has undergone any operation in the last six months,
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 activityThe application will last for 1-2 hours once a week for a total of 8 weeks. For individuals aged 65 years and over who meet the inclusion criteria and are included in the intervention group, a mandala draft in A4 format (21.0 cm x 29.7 cm) consisting of 8 round patterns to be determined in advance, and a dry paint set consisting of 12 colors for ease of use will be used. Quality dry paint will be used to prevent allergies | Other | Mandala activity group |
Primary outcome
Change in Anxiety Score Measured by the Geriatric Anxiety Scale (GAS) [Score Range: 0-75]
Time frame: Baseline and 8 weeks
Anxiety will be assessed using the Geriatric Anxiety Scale (GAS). The scale consists of 23 items scored from 0 to 3, with a total score ranging from 0 to 75. Higher scores indicate higher levels of anxiety.
1 secondary outcome
Change in Fatigue Severity Measured by the Fatigue Severity Scale (FSS) [Score Range: 9-63]
Time frame: Baseline and 8 weeks
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 18 Nov 2025.
- Individual participant dataSharing planned: No. "IPD will not be shared because of ethical and privacy considerations related to the vulnerable elderly population residing in a nursing home."
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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.
Can LAFÇI, PhDc principal investigator
Marmara 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 activity in people with Elderly Persons, run by Marmara 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 3 inclusion and 6 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 18 Nov 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?
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 Anxiety Score Measured by the Geriatric Anxiety Scale (GAS) [Score Range: 0-75] (time frame: Baseline and 8 weeks). 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 18 Nov 2025.