The Effect of Mandala Painting on Anxiety in Coronary Heart Patients

September 22, 2023 updated by: Gülşah Çamcı, Marmara University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
six days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gülşah Çamcı, PhD, Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MU-SBF-IHH-GC-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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