Mandala Coloring and Its Effect on Anxiety and Depression Before Open Heart Surgery (Mandala)

July 20, 2026 updated by: MERVE KAYA, Ataturk University

The Effect of Mandala Coloring on Anxiety and Depression Before Open Heart Surgery: A Randomized Controlled Trial

This study was conducted to determine the Effect of Mandala Coloring on Anxiety and Depression Before Open Heart Surgery. This was a randomized, controlled experimental study. The sample comprised 69 patients who underwent open heart surgery (control: 35; experimental: 34).

Eight pre-selected mandala drawings will be printed on separate A4 (21.0 cm × 29.7 cm) papers. After the patients are admitted to the hospital for the surgery process, the patients in the experimental group will be provided with at least 2 hours of mandala coloring per day until the day of their surgery. No intervention will be applied to the control group 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

Cardiovascular diseases are among the leading causes of death both globally and in our country. Despite advances in prevention, diagnosis, medical interventions, and surgical methods for heart diseases, "open heart surgery" remains one of the most effective methods in the treatment of cardiovascular disorders. For patients who do not respond to medical treatment, open heart surgery is often considered as a treatment option. Heart surgery is a surgical procedure that includes interventions on heart valves, repair of congenital defects, and coronary artery grafting. The surgical process is one of the most critical experiences in a patient's life, affecting them physically, psychologically, socially, and economically. Patients awaiting heart surgery experience high levels of anxiety and depression due to significant psychological stress, fear, worry, and uncertainties related to the surgery. For most patients, heart surgery is perceived as a crisis or a life-threatening event. When an individual faces a threatening event, it is cognitively assessed, and if deemed threatening, it triggers anxiety. Additionally, factors such as facing physically painful procedures, being away from family, losing a job, being in an unfamiliar environment, or encountering unknown devices can also contribute to anxiety during hospitalization.

Mandala is an art therapy technique that can provide psychological support and healing. This circular art has traditionally been used for meditation in various Asian cultures and symbolizes psychological wholeness. Mandala is a Sanskrit word meaning "circle, roundness, wholeness, and completion"; it provides mental calmness and relaxation. Mandala is used as a tool to enhance awareness, express oneself, solve negative problems, and promote healing. Mandala coloring is a safe and accessible activity that can be used as a complementary strategy to support mental health, requiring no special skills.

Through practices like mandala coloring, individuals project what they do not know onto the outside world and make it visible through this act of creation. The recovery process begins with this step. The artistic perspective of nursing involves understanding individuals' needs, identifying sources of anxiety and stress, and then developing practices that enhance people's abilities and competence, thus boosting their self-confidence and resilience. This study will be conducted to examine the effects of mandala coloring on anxiety and psychological well-being in patients undergoing open heart surgery.

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.
69

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 Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Erzurum
      • Yakutiye, Erzurum, Turkey (Türkiye), 25300
        • Ataturk 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Adults aged 18 years or older; Conscious, cooperative, and able to communicate fluently in Turkish; Undergoing first-time open-heart surgery; Having no history of autoimmune disease, rheumatic disease, multiple sclerosis, or corticosteroid-dependent disorders; Providing written informed consent voluntarily.

Exclusion Criteria:

Previous history of open-heart surgery; Cognitive impairment or inability to cooperate; Undergoing emergency surgery.

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: Supportive Care
  • 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: Mandala coloring Grup 1
This group will color mandalas before the surgery.
Other: Mandala coloring
Eight pre-selected mandala drawings will be printed on separate A4 (21.0 cm × 29.7 cm) papers. After the patients are admitted to the hospital for the surgery process, the patients in the experimental group will be provided with at least 30 minutes of mandala coloring per day until the day of their surgery. No intervention will be applied to the control group patients. Studies examining the effect of mandala coloring on reducing psychological symptoms have reported that using a circularly designed pattern in the mandala template, instead of a square design, has a greater effect on symptom management. Therefore, a circular-shaped mandala template will be used. Each participant will be provided with mandala coloring sheets and 12 colored pencils (red, orange, yellow, pink, light green, green, sky blue, blue, purple, brown, reddish-brown, and black) by the researcher.
Other Names:
  • mandala painting
No Intervention: No interventional: control grup Grup 2
This group will not color mandalas before the surgery.

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
Surgical Anxiety Scale
Time Frame: 1 day before surgery
The scale has three subdimensions: Health-Related Anxiety (items 7, 8, 9, 10, 12, and 13), Recovery-Related Anxiety (items 2, 14, 16, and 17), and Procedure-Related Anxiety (items 1, 3, 4, and 5). The total score of the Surgical Anxiety Scale (SAS) is obtained by summing the scores of the subdimension items and the three items not included in any subdimension. The lowest possible score on the scale is 0, and the highest score is 68. As the score increases, the level of surgical anxiety is considered higher.
1 day before surgery
Surgical Anxiety Scale
Time Frame: 7 day before surgery
The scale has three subdimensions: Health-Related Anxiety (items 7, 8, 9, 10, 12, and 13), Recovery-Related Anxiety (items 2, 14, 16, and 17), and Procedure-Related Anxiety (items 1, 3, 4, and 5). The total score of the Surgical Anxiety Scale (SAS) is obtained by summing the scores of the subdimension items and the three items not included in any subdimension. The lowest possible score on the scale is 0, and the highest score is 68. As the score increases, the level of surgical anxiety is considered higher.
7 day before surgery
Hospital Anxiety and Depression Scale
Time Frame: 7 day before surgery

The scale consists of 14 items, and it has two subdimensions: anxiety and depression. Seven items (odd numbers) measure anxiety, and seven items (even numbers) measure depression. The scale uses a 4-point Likert format, with scores ranging from 0 to 3. Each item on the scale has a different scoring method. Items 1, 3, 5, 6, 8, 10, 11, and 13 are reverse-scored, while items 2, 4, 7, 9, 12, and 14 are scored normally.

For the anxiety subdimension, the items 1, 3, 5, 7, 9, 11, and 13 are used; for the depression subdimension, the items 2, 4, 6, 8, 10, 12, and 14 are used. Patients can score between 0 and 21 on each subdimension. The cutoff point for anxiety is 10, and the cutoff point for depression is 7. Patients who score above these cutoff points are considered at risk.
7 day before surgery
Hospital Anxiety and Depression Scale
Time Frame: 1 day before surgery

The scale consists of 14 items, and it has two subdimensions: anxiety and depression. Seven items (odd numbers) measure anxiety, and seven items (even numbers) measure depression. The scale uses a 4-point Likert format, with scores ranging from 0 to 3. Each item on the scale has a different scoring method. Items 1, 3, 5, 6, 8, 10, 11, and 13 are reverse-scored, while items 2, 4, 7, 9, 12, and 14 are scored normally.

For the anxiety subdimension, the items 1, 3, 5, 7, 9, 11, and 13 are used; for the depression subdimension, the items 2, 4, 6, 8, 10, 12, and 14 are used. Patients can score between 0 and 21 on each subdimension. The cutoff point for anxiety is 10, and the cutoff point for depression is 7. Patients who score above these cutoff points are considered at risk.
1 day before surgery

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.
Ataturk 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.
February 1, 2025

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.
November 1, 2025

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.
November 1, 2025

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).
February 12, 2025

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.
February 12, 2025

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.
February 17, 2025

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.
July 22, 2026

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.
July 20, 2026

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.
July 1, 2026

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.
  • AtaturkUnıverstynursing

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

product manufactured in and exported from the U.S.

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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