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

NCT07162103 | Not Yet Recruiting

• 1 other identifier: 24-04-2025/ 95 /11
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Elderly Individuals Aged 60 Years or Older

Keywords

Elderly; Psychological well-being; Loneliness; Mandala

Outcome Measures

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)

  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"

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

Study Arms (2)

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".

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."

Interventions

GMART OTHER

Group Mandala Art Therapy

Intervention Group

Eligibility Criteria

• Age: 60 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Failure to attend a maximum of 3 sessions
• Withdrawal from the institution

Sponsors & Collaborators

• Suleyman Demirel University: lead

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In this study, researcher blinding will not be performed because the researchers who implemented the intervention and evaluated the data are the project managers.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 9, 2025
• Study Start: September 3, 2025
• Primary Completion: November 5, 2025
• Study Completion: November 12, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09