Group Mandala Art Therapy for Well-Being and Loneliness in the Elderly (GEMEL-WB:RCT)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-84
SponsorSuleyman Demirel University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
GMART
Other interventionGroup Mandala Art Therapy
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
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)
Time frame
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.
Time frame
Measurements will be made before the first session when the research begins and 12 weeks after the beginning.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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