NCT06077461

Brief Summary

THIS RESEARCH was planned to examine the effect of mandala painting on the perceived stress and anxiety levels of type-2 diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

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

First Submitted

Initial submission to the registry

October 5, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

October 5, 2023

Last Update Submit

February 12, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Perceived Stress Scale

    The Perceived Stress Scale was developed by Cohen, Kamarck and Mermelstein in 1983 to determine the level of stress that threatens human health. Turkish validity and reliability were determined by Eskin et al. (2013). The scale is a 5-point Likert type scale and consists of 14 items. As the scores obtained from the scale increase, the level of stress perceived by the person also increases. PSS scores vary between 0 and 56, with 0-35 points indicating normal stress level and 35-56 points indicating that the individual is under stress.

    after 7 days

  • State-Trait Anxiety Scale

    The State-Trait Anxiety Scale was developed by Spielberger et al. (1970). The validity and reliability of the scale in Turkey was determined by Öner and Le Compte (1983). The scale consists of two parts: State Anxiety Scale and Trait Anxiety Scale. The first 20 items evaluate situational anxiety, and the last 20 items evaluate trait anxiety. In this study, the scores obtained from the Scale, which is the first 20 items to evaluate situation-related anxiety, range between 20 and 80. Higher scores indicate higher levels of anxiety.

    after 7 days

Study Arms (2)

Experimental:mandala painting

EXPERIMENTAL

Patients in this group will be subjected to mandala painting.

Behavioral: mandala painting

Control

NO INTERVENTION

Patients in this group will not be subjected to mandala painting.

Interventions

Patients in this group will be subjected to mandala painting.

Experimental:mandala painting

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 18 and 65
  • Having been diagnosed with Type-2 diabetes for at least 6 months
  • Being an inpatient in the endocrine clinic for at least 7 days
  • Not having a physical problem that would prevent painting mandalas (vision, hearing, etc.)

You may not qualify if:

  • Not being able to use his hands actively
  • Having a communication problem
  • Having a learning problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firat University

Elâzığ, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is an experimental study with pre-test and post-test control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 11, 2023

Study Start

December 1, 2023

Primary Completion

May 25, 2024

Study Completion

December 1, 2024

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations