NCT07496268

Brief Summary

Objective This study aimed to investigate the effect of art-based mandala intervention on anger and death anxiety in older adults residing in a nursing home. Methods A randomized controlled experimental study with 80 participants (experimental group n = 40; control group n = 40) was conducted. The experimental group participated in mandala coloring three times a week for 12 weeks. Data were collected using a descriptive form, a death anxiety scale, and the State-Trait Anger Expression Inventory.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 11, 2026

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Death Anxiety Scale

    Death Anxiety Scale: The validity and reliability study of the Turkish version of the "Death Anxiety Scale". The scale 15-item true/false scale measures anxiety and fear related to one's own death and mortality risk. Each "yes" response to the first nine items and each "no" response to the remaining six items receives a score of "1." The total score indicates the level of death anxiety. The maximum possible score is 15, with scores interpreted as follows: 0-4 (mild), 5-9 (moderate), 10-14 (severe), and 15 (panic).

    Baseline and 12 weeks follow-up

Study Arms (2)

Mandala

EXPERIMENTAL

Mandala

Behavioral: Mnadala coloring

Control

OTHER

do nothing

Behavioral: Control

Interventions

Mnadala coloring

Mandala
ControlBEHAVIORAL

do nothing

Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • residing in the nursing home, being 65 years of age or older, scoring 24 or more points on the Mini-Mental State Examination, having no psychiatric diagnoses, not currently participating in courses related to coping with anxiety and stress, and voluntarily agreeing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Kartal, 34862, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Necrophobia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This randomized controlled trial involved older adults who engaged in mandala coloring three times a week for 12 weeks. Based on the assumption that mandala coloring could reduce thanatophobia (fear of death) levels by 30 % (effect size dz: 0.5), a sample size of at least 35 participants per group was determined using a power of 95 %, alpha of 0.05, and beta of 0.20. Anticipating potential attrition, 100 participants were initially enrolled. After applying exclusion criteria, the study was completed with 80 participants (experimental group n = 40; control group n = 40). The researchers created a flow diagram based on CONSORT guidelines. Due to the nature of the intervention, blinding of the participants was not possible. Upon study completion, an independent statistician, blinded to group allocation, analyzed the data and reported the findings.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 27, 2026

Study Start

April 12, 2024

Primary Completion

April 24, 2025

Study Completion

June 23, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations