The Effect of Art-based Mandala Intervention | NCT07496268

Studies
The Effect of Art-based Mandala Intervention

NCT07496268

Sponsor

Istanbul Medeniyet University

Status

Completed

Last Update Posted

Mar 27, 2026Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Art Therapy
Mandala Coloring
Anger
Death Anxiety
Elderly

Interventions

Mnadala coloring
Control

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2024Actual

Primary Completion Date

Apr 24, 2025Actual

Completion Date

Jun 23, 2025Actual

First Submitted Date

Mar 11, 2026

First Submission Date that Met QC Criteria

Mar 23, 2026

First Posted Date

Mar 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2026

Last Update Posted Date

Mar 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mandala	Experimental	Mandala	Behavioral: Mnadala coloring
Control	Other	do nothing	Behavioral: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mnadala coloring	Behavioral	Mnadala coloring	Mandala
Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

out of the inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Medeniyet University		Istanbul	Kartal	34862	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C000719207	Necrophobia

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.