NCT06830837

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 20, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

February 17, 2025

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

February 12, 2025

Last Update Submit

February 12, 2025

Conditions

Keywords

heart surgeryanxietymandala coloringDepression

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

EXPERIMENTAL

This group will color mandalas before the surgery.

Other: Mandala coloring

No interventional: control grup Grup 2

NO INTERVENTION

This 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.

Also known as: mandala painting
Intervention: Mandala coloring Grup 1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Central Study Contacts

ZEYNEP KARAMAN ÖZLÜ

CONTACT

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