The Effect of Mandala Painting on Anxiety in Coronary Heart Patients

Sponsor

Marmara University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05307224

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Anxiety	Device: Mandala	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Official Title:

The Effect of Mandala Painting on Anxiety in Coronary Heart Patients: A Randomized Controlled Trial

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	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 Names: Mandala Painting
No Intervention: control group The control group will receive the usual care.

Arm

Intervention/Treatment

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.

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 Names:

Mandala Painting

No Intervention: control group

The control group will receive the usual care.

Outcome Measures

Primary Outcome Measures

The Hospital Anxiety and Depression Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)