Heart SurgeryMandalaNCT06830837
Mandala Coloring and Its Effect on Anxiety and Depression Before Open Heart Surgery
A study testing Mandala coloring in people with Heart Surgery and Mandala Painting, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Surgery, Mandala Painting, Anxiety
- What is being tested?
- Mandala coloring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous history of open-heart surgery; Cognitive impairment or inability to cooperate; Undergoing emergency surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Surgery, Mandala Painting, Anxiety
- Being tested
- Mandala coloring
- Keywords
- heart surgery, anxiety, mandala coloring, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala coloringOther
Also called mandala painting
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Mandala coloring Grup 1 | Experimental | This group will color mandalas before the surgery. Receives: Other: Mandala coloring |
| No interventional: control grup Grup 2 | No intervention | This group will not color mandalas before the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Anxiety Scale
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.
Measured: 7 day before surgery
Surgical Anxiety Scale
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.
Measured: 1 day before surgery
Hospital Anxiety and Depression Scale
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.
Measured: 7 day before surgery
Hospital Anxiety and Depression Scale
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.
Measured: 1 day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Feb 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MERVE KAYA, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830837
- Sponsor's protocol ID
- AtaturkUnıverstynursing
- Acronym
- Mandala
- Status last verified
- Jul 2026
- First submitted
- 12 Feb 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring on Anxiety and Depression Before Open Heart Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06830837
- Acronym / sponsor ID
- Mandala / AtaturkUnıverstynursing
- Conditions
- Heart Surgery, Mandala Painting, Anxiety
- Keywords
- heart surgery, anxiety, mandala coloring, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Mandala coloring Grup 1 | Experimental | Other: Mandala coloringThis group will color mandalas before the surgery. |
| No interventional: control grup Grup 2 | No intervention | –This group will not color mandalas before the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Previous history of open-heart surgery; Cognitive impairment or inability to cooperate; Undergoing emergency surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandala coloringAlso: mandala paintingEight 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 | Intervention: Mandala coloring Grup 1 |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala coloring in people with Heart Surgery and Mandala Painting, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Anxiety Scale (time frame: 7 day before surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.