Not Yet RecruitingNot Applicable

Group Mandala Art Therapy for Well-Being and Loneliness in the Elderly (GEMEL-WB:RCT)

58 participantsStarted 2025-09-03

Plain-language 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. 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.

Who can participate

Age range

60 Years – 84 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

"Loneliness Scale for the Elderly"

Timeframe: Measurements will be made before the first session when the research begins and 12 weeks after the beginning.

Trial details

NCT IDNCT07162103

SponsorSuleyman Demirel University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-05

View on ClinicalTrials.gov More Elderly Individuals Aged 60 Years or Older trials