The Effect of Mandala Painting on Anxiety in Coronary Heart Patients

NCT ID: NCT05307224

Last Updated: 2023-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-09

Study Completion Date

2023-09-23

Brief Summary

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This study was planned as a randomized controlled trial to determine the effect of mandala painting on the anxiety of coronary heart patients.

Detailed Description

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Patients in the control group will receive routine care.Patiens in the experimental group will receive routine care and mandala painting. Experimental group will paint mandala for 30 minutes/day in the evenings for six consecutive days. In order not to interrupt the duties of the nurse and doctor in the clinic, it was planned for the experimental group to paint mandalas in the evening. Six pre-selected mandalas were planned to be printed separately on A4 paper. Each patient will be given a new mandala each day. At the beginning of the study, six colors will be given to the experimental group (yellow, blue, green, red, purple, brown). It was planned to do it for 6 days, as it was found that painting mandala for more than a week in the studies could reduce the patient's attention. In addition, based on the average hospitalization days of the patients, reaching patients for more than a week will be a problem.

Conditions

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Coronary Artery Disease Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

control group (usual care) and experimental group (mandala painting)
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
It was planned to use block randomization for the random assignment of patients to the experimental and control groups.

Study Groups

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intervention group

In the experimental group, patients will receive both routine care and mandala painting. Experimental group will paint mandala for 30 minutes/day in the evening for six consecutive days.

Group Type EXPERIMENTAL

Mandala

Intervention Type DEVICE

Experimental group will paint mandala for 30 minutes/day in the evenings for six consecutive days. Six pre-selected mandalas were planned to be printed separately on A4 paper. Each patient will be given a new mandala each day. Additionally, At the beginning of the study, the experimental group will be given six colors (yellow, blue, green, red, purple, brown).

control group

The control group will receive the usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mandala

Experimental group will paint mandala for 30 minutes/day in the evenings for six consecutive days. Six pre-selected mandalas were planned to be printed separately on A4 paper. Each patient will be given a new mandala each day. Additionally, At the beginning of the study, the experimental group will be given six colors (yellow, blue, green, red, purple, brown).

Intervention Type DEVICE

Other Intervention Names

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Mandala Painting

Eligibility Criteria

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Inclusion Criteria

* Having agreed to participate in the research/approved the informed consent form
* No visual or hearing impairment
* Hospitalization due to Coronary Heart Disease (patients hospitalized with the diagnosis of acute coronary syndromes such as stable angina, unstable angina, myocardial infarction, percutaneous coronary intervention and stent implantation),
* Being over 18 years old,
* Being at least literate
* The absence of any problem that would prevent him/her from painting mandala (no problem in his arm or hand that would prevent his movement (such as paralysis, or the presence of a catheter on the hand), no serious illness)
* Must not have a diagnosis of mental illness/anxiety disorder

Exclusion Criteria

* Control group patients who coincided with the same room as the intervention group, by randomization.
* Patients who want to quit the study voluntarily during the study
* Patients whose general condition deteriorates (such as altered hemodynamics or consciousness)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Gülşah Çamcı

Assistant Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülşah Çamcı, PhD

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

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Marmara University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MU-SBF-IHH-GC-02

Identifier Type: -

Identifier Source: org_study_id

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