Mandala Coloring and Its Effect on Anxiety and Depression Before Open Heart Surgery
Heart Surgery
The Effect of Mandala Coloring on Anxiety and Depression Before Open Heart Surgery: a Randomized Controlled Trial
1 other identifier
interventional
84
0 countries
N/A
Brief 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 84 patients who underwent open heart surgery (control: 41; experimental: 43). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2025
CompletedFirst Posted
Study publicly available on registry
February 17, 2025
CompletedStudy Start
First participant enrolled
March 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2025
CompletedFebruary 17, 2025
December 1, 2024
6 months
February 12, 2025
February 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
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.
1 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.
On the day of 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.
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.
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.
On the day of surgery
Study Arms (2)
Intervention: Mandala coloring Grup 1
EXPERIMENTALThis group will color mandalas before the surgery.
No interventional: control grup Grup 2
NO INTERVENTIONThis group will not color mandalas before the surgery.
Interventions
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. 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.
Eligibility Criteria
You may qualify if:
- Having no history of previous cardiothoracic surgery, eing newly diagnosed with CAD and registered on a wait list for CABG surgery, having literacy in the Turkish language
You may not qualify if:
- having a history of cognitive impairment, having other life-threatening medical conditions, such as cancer or stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 12, 2025
First Posted
February 17, 2025
Study Start
March 20, 2025
Primary Completion
September 20, 2025
Study Completion
December 20, 2025
Last Updated
February 17, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share