The Effect of Mandala Painting on Anxiety in Coronary Heart Patients

• ClinicalTrials.gov Identifier: NCT05307224
• Recruitment Status: Completed
• First Posted: April 1, 2022
• Last Update Posted: September 25, 2023
• Sponsor: Marmara University
• Information provided by (Responsible Party): Gülşah Çamcı, Marmara University

Tracking Information

• First Submitted Date: March 23, 2022
• First Posted Date: April 1, 2022
• Last Update Posted Date: September 25, 2023
• Actual Study Start Date: August 9, 2023
• Actual Primary Completion Date: August 9, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 23, 2022)

The Hospital Anxiety and Depression Scale [ Time Frame: six days ]

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Mandala Painting on Anxiety in Coronary Heart Patients
• Official Title: The Effect of Mandala Painting on Anxiety in Coronary Heart Patients: A Randomized Controlled Trial
• 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.
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

control group (usual care) and experimental group (mandala painting)

Masking: Single (Participant)
Masking Description:

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

Primary Purpose: Prevention

Condition

• Coronary Artery Disease
• Anxiety

Intervention

Device: 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).

Other Name: Mandala Painting

Study Arms

• Experimental: 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.
  Intervention: Device: Mandala
• No Intervention: control group
  The control group will receive the usual care.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 22, 2023): 60
• Original Estimated Enrollment (submitted: March 23, 2022): 50
• Actual Study Completion Date: September 23, 2023
• Actual Primary Completion Date: August 9, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT05307224
• Other Study ID Numbers: MU-SBF-IHH-GC-02
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Gülşah Çamcı, Marmara University
• Original Responsible Party: Same as current
• Current Study Sponsor: Marmara University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gülşah Çamcı, PhD; Marmara University

• PRS Account: Marmara University
• Verification Date: September 2023