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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Suleyman Demirel University

    Isparta

Other trials in Turkey (Türkiye)

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 groups in NCT07162103
Study groupRoleWhat they receive
Intervention GroupExperimentalTwelve 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 GroupNo interventionThe 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.

  1. "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)
  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.

  1. First posted9 Sep 2025
  2. Study start6 Oct 2025
  3. Primary completion24 Dec 2025
  4. Study completion24 Dec 2025

Resources

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)
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

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.

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