The Effect of Mandala Painting on Anxiety in Coronary Heart Patients

NCT05307224 | Completed

• 1 other identifier: MU-SBF-IHH-GC-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease; Anxiety

Keywords

Coronary Artery Disease; Anxiety; mandala

Outcome Measures

Primary Outcomes (1)

• The Hospital Anxiety and Depression Scale

  The scale consists of 14 items including 7 anxiety and 7 depression questions. Responses are in the form of a four-point likert. Each item is scored between 0 and 3, and the cut-off points of the scale were found to be 10 for the anxiety subscale and 7 for the depression subscale. Individuals who score above these scores are considered at risk. The scoring score of each item in the scale is different, and the 1st, 3rd, 5th, 6th, 8th, 10th, 11th and 13th items show that the severity is gradually decreasing and its scoring is 3, 2, 1, 0. The 2nd, 4th, 7th, 9th, 12th and 14th items of the scale are scored as 0, 1, 2, 3. Items 1, 3, 5, 7, 9, 11, and 13 for the anxiety subscale, and items 2, 4, 6, 8, 10, 12, and 14 for the depression subscale. The scores of the items are summed. The lowest zero and the highest 21 points can be obtained from both sub-dimensions of the scale.

  six days

Study Arms (2)

intervention group

EXPERIMENTAL

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.

Device: Mandala

control group

NO INTERVENTION

The control group will receive the usual care.

Interventions

Mandala 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).

Also known as: Mandala Painting

intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Mental Disorders

Study Officials

• Gülşah Çamcı, PhD

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It was planned to use block randomization for the random assignment of patients to the experimental and control groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof

Model Details: control group (usual care) and experimental group (mandala painting)

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: August 9, 2023
• Primary Completion: August 9, 2023
• Study Completion: September 23, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)