The Effect of Mandala Painting on Anxiety in Coronary Heart Patients
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ClinicalTrials.gov Identifier: NCT05307224 |
Recruitment Status :
Completed
First Posted : April 1, 2022
Last Update Posted : September 25, 2023
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease Anxiety | Device: Mandala | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | control group (usual care) and experimental group (mandala painting) |
Masking: | Single (Participant) |
Masking Description: | It was planned to use block randomization for the random assignment of patients to the experimental and control groups. |
Primary Purpose: | Prevention |
Official Title: | The Effect of Mandala Painting on Anxiety in Coronary Heart Patients: A Randomized Controlled Trial |
Actual Study Start Date : | August 9, 2023 |
Actual Primary Completion Date : | August 9, 2023 |
Actual Study Completion Date : | September 23, 2023 |
Arm | Intervention/treatment |
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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.
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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 Name: Mandala Painting |
No Intervention: control group
The control group will receive the usual care.
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- 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.
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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05307224
Turkey | |
Marmara University | |
Istanbul, Turkey |
Principal Investigator: | Gülşah Çamcı, PhD | Marmara University |
Responsible Party: | Gülşah Çamcı, Assistant Prof, Marmara University |
ClinicalTrials.gov Identifier: | NCT05307224 |
Other Study ID Numbers: |
MU-SBF-IHH-GC-02 |
First Posted: | April 1, 2022 Key Record Dates |
Last Update Posted: | September 25, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Coronary Artery Disease Anxiety mandala |
Coronary Artery Disease Myocardial Ischemia Coronary Disease Anxiety Disorders Mental Disorders |
Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |