Elderly Individuals Aged 60 Years or OlderGEMEL-WB:RCTNCT07162103
Group Mandala Art Therapy for Well-Being and Loneliness in the Elderly (GEMEL-WB:RCT)
A study testing GMART in people with Elderly Individuals Aged 60 Years or Older, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
The research is being conducted at an elderly day care center between June 12 and August 31, 2025, as a single-blind randomized controlled experimental study using a pre-test, post-test design. Read more about this study
- Who is it for?
- Ages 60 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly Individuals Aged 60 Years or Older
- What is being tested?
- GMART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Oct 2025to 24 Dec 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 60 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer to participate in the study
- No special conditions that would cause cognitive difficulties (auditory or visual impairments, etc.)
- Standardized Mini Mental State Examination (SMMT) score: 23-30 points (no cognitive impairment or mild cognitive impairment)
Who cannot join
- Presence of a mental or physical disability that prevents communication and attendance at sessions (inability to speak, severe dementia, etc.) Study Exclusion Criteria Indicated desire to withdraw from the study
- Failure to attend a maximum of 3 sessions
- Withdrawal from the institution
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effects of Group Mandala Art Therapy on Psychological Well-Being and Loneliness Levels in the Elderly
The research is being conducted at an elderly day care center between June 12 and August 31, 2025, as a single-blind randomized controlled experimental study using a pre-test, post-test design. Prior to the research, approval was obtained from the scale owners, the participants, the ethics committee, and the institution's implementation permit. The research population consists of 300 individuals registered at the institution. The study sample will consist of 58 individuals (intervention-29 and control-29) who met the inclusion criteria, were selected using the block randomization method, and provided informed consent. The control group will not receive any intervention, and a pre-test will be administered on the first day, and a post-test will be administered on the day the intervention for the experimental group concluded (Week 12). The intervention group will receive 12 sessions of group mandala art therapy once a week, with a pre-test on the first day and a post-test in the last session (Week 12) following the intervention. Data will be collected using the Personal Information Form (PIF) (Appendix 1), Standardized Mini Mental Test, Psychological Well-Being Scale for the Elderly (YPİOÖ), and Loneliness Scale for the Elderly. Data will be analyzed using the SPSS (Statistical Program for Social Sciences) statistical analysis package program, with statistical significance considered at p <0.05.
Read the detailed description
The problems associated with aging and the increasing elderly population have led to an increase in the healthcare and rehabilitation needs of older individuals, and the psychosocial health of older individuals has become a global public health concern. Elderly individuals living in nursing homes, in particular, need health promotion activities that will improve their emotional well-being, cognitive status, and physical condition, or reduce problematic behaviors. In this context, art therapy, a supportive method aligned with the biopsychosocial approach, is recommended for interventions aimed at protecting and improving the mental health of older individuals. Art therapy, included in the Nursing Intervention Classification, is a supportive method that helps individuals express themselves, acquire coping skills, develop interpersonal skills, increase resilience, resolve conflicts and problems, manage their behaviors, reduce stress, increase self-esteem and self-confidence, and gain insight using art as a tool, all contributing to psychological well-being. Some studies have emphasized the impact of art-related activities on the health of older individuals. According to the literature, utilizing art in individual or group work with older individuals improves their physical and psychosocial health, reduces functional impairments, increases life satisfaction and quality, and enhances self-confidence. It is suggested that mandala creation, a frequently used technique in art therapy, not only provides insight into certain dynamics underlying an individual's subconscious, such as anxiety, fear, and internal conflicts, but also positively impacts the individual's "healing" process. Mandala is considered by art psychotherapists as a psychotherapy technique that provides psychological support and healing.
Maintaining active social relationships among older individuals is important for preventing feelings of loneliness, a symptom of a lack of social relationships, and for increasing psychological well-being. Social relationships can be maintained through close connections with the environment or through hobbies and recreational activities. The purpose of this study is to examine the effects of mandala art therapy group practices on the levels of loneliness and psychological well-being of older individuals living in nursing homes. Consequently, since its inception, nursing has prioritized the holistic healing and recovery of individuals under its care and responsibility, grounded in an existential-humanistic understanding. Since Florence Nightingale, considered the founder of environmental interaction theory and modern nursing, therapeutic management of an individual's environment and setting has held a prominent place among nurses' roles and responsibilities. In this sense, creating a healing/therapeutic environment is a fundamental component of nursing care. In this context, nurses must provide a healing environment enriched with activities to maintain and support the well-being of older individuals, their sense of meaning and purpose in life. Therefore, in the face of a rapidly aging population, encouraging the use of evidence-based interventions to enhance or maintain the well-being of older individuals is crucial. No studies have been found in the literature examining the levels of loneliness and psychological well-being in older individuals using single mandala art therapy. This study has several strengths, including the inclusion of intervention and non-intervention groups, the consistency of the frequency and number of group sessions and materials with the literature, and the examination of comprehensive variables within the life cycle of older adults, such as loneliness and psychological well-being. It is also believed to make significant contributions to the fields of geriatric psychology and art therapy.
In line with the purpose of the study, the hypotheses are as follows:
Hypothesis 1 (H1): Elderly individuals who received group mandala art therapy will have higher post-intervention well-being levels than the control group.
Hypothesis 2 (H1): Elderly individuals who received group mandala art therapy will have lower post-intervention loneliness levels than the control group.
Hypothesis 3 (H1): There is a negative relationship between the well-being and loneliness levels of elderly individuals who received and did not receive group mandala art therapy.
Research Conduct A preliminary study will be conducted with one participant to determine the effectiveness and duration of the measurement tools and group mandala art therapy sessions. The study will be conducted in an elderly daycare center as a single-blind randomized controlled experimental study with a pretest-posttest design. Participants will be provided with an Informed Consent Form and surveys at the beginning of the first session. All participants will complete the surveys at the pretest level and will then be randomized into one of two groups. The control group will not receive any intervention; a posttest will be administered three months after the initial measurements. The control group will also receive the intervention after the research period is concluded. The experimental group will receive the intervention; a posttest will be administered three months after the initial measurements. The study, which will be conducted face-to-face, is planned to consist of twelve (12) sessions, each 90-minute session, once a week for the experimental group. No intervention will be administered to the control group.
- Being tested
- GMART
- Keywords
- Elderly, Psychological well-being, Loneliness, Mandala
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMARTOther
Group Mandala Art Therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Twelve sessions of group mandala art therapy (GMART)will be applied to the intervention group once a week, and a pretest will be taken in the first session and a posttest will be taken after the 12th week using the "Loneliness Scale for the Elderly" and the "Psychological Well-Being Scale for the Elderly". Receives: Other: GMART |
| Control Group | No intervention | The control group will not receive any intervention, and pretest and posttest data will be collected after the first and 12 weeks using the "Loneliness Scale for the Elderly" and "Psychological Well-Being Scale for the Elderly." |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Loneliness Scale for the Elderly"
The extent to which a person experiences the situation described in each statement on the scale is determined using a 3-point Likert-type scale. The scale is rated as follows: 0 = yes, 1 = maybe, 2 = no. Responses are made by selecting the rating statement that best describes the individual. Five of the scale items are coded linearly, and six are reverse-coded. The items belonging to the social loneliness sub-dimension (1, 4, 7, 8, and 11), which contain positive expressions, are scored as 0 = yes, 1 = maybe, 2 = no; the items belonging to the emotional loneliness sub-dimension (2, 3, 5, 6, 9, and 10), which contain negative expressions, are scored as 2 = yes, 1 = maybe, 0 = no. The lowest possible score on the scale is 0, and the highest is 22. Total loneliness can be divided into four levels: Level 1: Not lonely/does not feel lonely (scores 0-4); Level 2: Acceptable loneliness (score 5-14); Level 3: Very lonely (score 15-18); Level 4: Very intense loneliness (score 19-22)
Measured: Measurements will be made before the first session when the research begins and 12 weeks after the beginning.
Secondary outcomes (1)
"Psychological Well-Being Scale for the Elderly"
It is a self-reported, 5-point Likert-type scale (1 = completely disagree - 5 = completely agree) that measures psychological well-being in older adults. There is no cut-off score for well-being in older adults based on the scale's scoring. Increasing scores indicate increasing well-being. The minimum score on the scale is 15, and the maximum score is 75.
Measured: Measurements will be made before the first session when the research begins and 12 weeks after the beginning.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start6 Oct 2025
- Primary completion24 Dec 2025
- Study completion24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly Individuals Aged 60 Years or OlderStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Sema Soysal, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162103
- Sponsor's protocol ID
- 24-04-2025/ 95 /11
- Acronym
- GEMEL-WB:RCT
- Status last verified
- Jul 2026
- First submitted
- 28 Aug 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Group Mandala Art Therapy on Psychological Well-Being and Loneliness Levels in the Elderly
- ClinicalTrials.gov ID
- NCT07162103
- Acronym / sponsor ID
- GEMEL-WB:RCT / 24-04-2025/ 95 /11
- Keywords
- Elderly, Psychological well-being, Loneliness, Mandala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 9 Sep 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.
The research is being conducted at an elderly day care center between June 12 and August 31, 2025, as a single-blind randomized controlled experimental study using a pre-test, post-test design. Prior to the research, approval was obtained from the scale owners, the participants, the ethics committee, and the institution's implementation permit. The research population consists of 300 individuals registered at the institution. The study sample will consist of 58 individuals (intervention-29 and control-29) who met the inclusion criteria, were selected using the block randomization method, and provided informed consent. The control group will not receive any intervention, and a pre-test will be administered on the first day, and a post-test will be administered on the day the intervention for the experimental group concluded (Week 12). The intervention group will receive 12 sessions of group mandala art therapy once a week, with a pre-test on the first day and a post-test in the last session (Week 12) following the intervention. Data will be collected using the Personal Information Form (PIF) (Appendix 1), Standardized Mini Mental Test, Psychological Well-Being Scale for the Elderly (YPİOÖ), and Loneliness Scale for the Elderly. Data will be analyzed using the SPSS (Statistical Program for Social Sciences) statistical analysis package program, with statistical significance considered at p <0.05.
Detailed description
The problems associated with aging and the increasing elderly population have led to an increase in the healthcare and rehabilitation needs of older individuals, and the psychosocial health of older individuals has become a global public health concern. Elderly individuals living in nursing homes, in particular, need health promotion activities that will improve their emotional well-being, cognitive status, and physical condition, or reduce problematic behaviors. In this context, art therapy, a supportive method aligned with the biopsychosocial approach, is recommended for interventions aimed at protecting and improving the mental health of older individuals. Art therapy, included in the Nursing Intervention Classification, is a supportive method that helps individuals express themselves, acquire coping skills, develop interpersonal skills, increase resilience, resolve conflicts and problems, manage their behaviors, reduce stress, increase self-esteem and self-confidence, and gain insight using art as a tool, all contributing to psychological well-being. Some studies have emphasized the impact of art-related activities on the health of older individuals. According to the literature, utilizing art in individual or group work with older individuals improves their physical and psychosocial health, reduces functional impairments, increases life satisfaction and quality, and enhances self-confidence. It is suggested that mandala creation, a frequently used technique in art therapy, not only provides insight into certain dynamics underlying an individual's subconscious, such as anxiety, fear, and internal conflicts, but also positively impacts the individual's "healing" process. Mandala is considered by art psychotherapists as a psychotherapy technique that provides psychological support and healing.
Maintaining active social relationships among older individuals is important for preventing feelings of loneliness, a symptom of a lack of social relationships, and for increasing psychological well-being. Social relationships can be maintained through close connections with the environment or through hobbies and recreational activities. The purpose of this study is to examine the effects of mandala art therapy group practices on the levels of loneliness and psychological well-being of older individuals living in nursing homes. Consequently, since its inception, nursing has prioritized the holistic healing and recovery of individuals under its care and responsibility, grounded in an existential-humanistic understanding. Since Florence Nightingale, considered the founder of environmental interaction theory and modern nursing, therapeutic management of an individual's environment and setting has held a prominent place among nurses' roles and responsibilities. In this sense, creating a healing/therapeutic environment is a fundamental component of nursing care. In this context, nurses must provide a healing environment enriched with activities to maintain and support the well-being of older individuals, their sense of meaning and purpose in life. Therefore, in the face of a rapidly aging population, encouraging the use of evidence-based interventions to enhance or maintain the well-being of older individuals is crucial. No studies have been found in the literature examining the levels of loneliness and psychological well-being in older individuals using single mandala art therapy. This study has several strengths, including the inclusion of intervention and non-intervention groups, the consistency of the frequency and number of group sessions and materials with the literature, and the examination of comprehensive variables within the life cycle of older adults, such as loneliness and psychological well-being. It is also believed to make significant contributions to the fields of geriatric psychology and art therapy.
In line with the purpose of the study, the hypotheses are as follows:
Hypothesis 1 (H1): Elderly individuals who received group mandala art therapy will have higher post-intervention well-being levels than the control group.
Hypothesis 2 (H1): Elderly individuals who received group mandala art therapy will have lower post-intervention loneliness levels than the control group.
Hypothesis 3 (H1): There is a negative relationship between the well-being and loneliness levels of elderly individuals who received and did not receive group mandala art therapy.
Research Conduct A preliminary study will be conducted with one participant to determine the effectiveness and duration of the measurement tools and group mandala art therapy sessions. The study will be conducted in an elderly daycare center as a single-blind randomized controlled experimental study with a pretest-posttest design. Participants will be provided with an Informed Consent Form and surveys at the beginning of the first session. All participants will complete the surveys at the pretest level and will then be randomized into one of two groups. The control group will not receive any intervention; a posttest will be administered three months after the initial measurements. The control group will also receive the intervention after the research period is concluded. The experimental group will receive the intervention; a posttest will be administered three months after the initial measurements. The study, which will be conducted face-to-face, is planned to consist of twelve (12) sessions, each 90-minute session, once a week for the experimental group. No intervention will be administered to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: GMARTTwelve sessions of group mandala art therapy (GMART)will be applied to the intervention group once a week, and a pretest will be taken in the first session and a posttest will be taken after the 12th week using the "Loneliness Scale for the Elderly" and the "Psychological Well-Being Scale for the Elderly". |
| Control Group | No intervention | –The control group will not receive any intervention, and pretest and posttest data will be collected after the first and 12 weeks using the "Loneliness Scale for the Elderly" and "Psychological Well-Being Scale for the Elderly." |
Who may qualify
- Ages
- 60 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteer to participate in the study
- No special conditions that would cause cognitive difficulties (auditory or visual impairments, etc.)
- Standardized Mini Mental State Examination (SMMT) score: 23-30 points (no cognitive impairment or mild cognitive impairment)
Key exclusion criteria (3 listed)
- Presence of a mental or physical disability that prevents communication and attendance at sessions (inability to speak, severe dementia, etc.) Study Exclusion Criteria Indicated desire to withdraw from the study
- Failure to attend a maximum of 3 sessions
- Withdrawal from the institution
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 |
|---|---|---|
| GMARTGroup Mandala Art Therapy | Other | Intervention Group |
Primary outcome
"Loneliness Scale for the Elderly"
Time frame: Measurements will be made before the first session when the research begins and 12 weeks after the beginning.
The extent to which a person experiences the situation described in each statement on the scale is determined using a 3-point Likert-type scale. The scale is rated as follows: 0 = yes, 1 = maybe, 2 = no. Responses are made by selecting the rating statement that best describes the individual. Five of the scale items are coded linearly, and six are reverse-coded. The items belonging to the social loneliness sub-dimension (1, 4, 7, 8, and 11), which contain positive expressions, are scored as 0 = yes, 1 = maybe, 2 = no; the items belonging to the emotional loneliness sub-dimension (2, 3, 5, 6, 9, and 10), which contain negative expressions, are scored as 2 = yes, 1 = maybe, 0 = no. The lowest possible score on the scale is 0, and the highest is 22. Total loneliness can be divided into four levels: Level 1: Not lonely/does not feel lonely (scores 0-4); Level 2: Acceptable loneliness (score 5-14); Level 3: Very lonely (score 15-18); Level 4: Very intense loneliness (score 19-22)
1 secondary outcome
"Psychological Well-Being Scale for the Elderly"
Time frame: Measurements will be made before the first session when the research begins and 12 weeks after the beginning.
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 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Elderly Individuals Aged 60 Years or Older
Active, not recruitingObservational study
SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER
Respiratory Syncytial Virus Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GMART in people with Elderly Individuals Aged 60 Years or Older, run by Suleyman Demirel 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 3 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 28 Jul 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?
"Loneliness Scale for the Elderly" (time frame: Measurements will be made before the first session when the research begins and 12 weeks after the beginning.). 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 28 Jul 2026.