Mandala for Anxiety, Fatigue, and Sleep

NCT07145853 | Completed

• 1 other identifier: MarmaraU-HB-CL-34
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Looking at the studies on social activity programs in individuals living in nursing homes in the literature, it was seen that the studies on Mandala therapy were limited. In this study, it is aimed to examine the effect of Mandala application, known as art therapy, on anxiety, fatigue and sleep quality in individuals living in nursing homes.

Conditions

Elderly Persons

Keywords

art therapy; Nursing Homes; Anxiety; fatigue; Sleep Quality

Outcome Measures

Primary Outcomes (1)

• Change in Anxiety Score Measured by the Geriatric Anxiety Scale (GAS) [Score Range: 0-75]

  Anxiety will be assessed using the Geriatric Anxiety Scale (GAS). The scale consists of 23 items scored from 0 to 3, with a total score ranging from 0 to 75. Higher scores indicate higher levels of anxiety.

  Baseline and 8 weeks

Secondary Outcomes (1)

• Change in Fatigue Severity Measured by the Fatigue Severity Scale (FSS) [Score Range: 9-63]

  Baseline and 8 weeks

Other Outcomes (1)

• Change in Sleep Quality Score Measured by the Pittsburgh Sleep Quality Index (PSQI) [Score Range: 0-21]

  Baseline and 8 weeks

Study Arms (2)

Mandala activity group

EXPERIMENTAL

The application will last for 1-2 hours once a week for a total of 8 weeks. For individuals aged 65 years and over who meet the inclusion criteria and are included in the intervention group, a mandala draft in A4 format (21.0 cm x 29.7 cm) consisting of 8 round patterns to be determined in advance, and a dry paint set consisting of 12 colors for ease of use will be used. Quality dry paint will be used to prevent allergies

Other: Mandala activity

Control Group

NO INTERVENTION

No intervention will be applied to the control group. The dry paint and mandala drafts necessary to overcome the deprivation of the control group will be left for them to do the activity after the study is completed.

Interventions

Mandala activity OTHER

The application will last for 1-2 hours once a week for a total of 8 weeks. For individuals aged 65 years and over who meet the inclusion criteria and are included in the intervention group, a mandala draft in A4 format (21.0 cm x 29.7 cm) consisting of 8 round patterns to be determined in advance, and a dry paint set consisting of 12 colors for ease of use will be used. Quality dry paint will be used to prevent allergies

Mandala activity group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Individuals aged 65 years and older with a score of 24 and above on the Mini Mental State Examination
• Ability to use/hold a pen
• Individuals without allergies,

You may not qualify if:

• Unable to communicate verbally
• Unable to act independently,
• Severe vision loss,
• People with neurological diseases such as stroke, Parkinson's, multiple sclerosis, dementia, etc,
• Has undergone any operation in the last six months,
• Individuals aged 65 and over diagnosed with cancer

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Faculty of Health Sciences, Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Fatigue; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Can LAFÇI, PhDc

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Individuals included in the study will be randomized from the random.org website. Data will be collected twice in the intervention and control groups as pre-test and post-test. The pre-test of the study will be administered between May 2025-Septemb2025 and the post-test will be administered to individuals who completed the 8-week mandala activity in the intervention group. The descriptive questionnaire (Appendix-1) will not be applied in the post-test since the variables to be applied in the pre-test are fixed. Mandala activity will be applied to the intervention group.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 28, 2025
• Study Start: May 30, 2025
• Primary Completion: August 14, 2025
• Study Completion: November 12, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)