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Completed

NCT Number: NCT05307224

The Effect of Mandala Painting on Anxiety in Coronary Heart Patients

This study was planned as a randomized controlled trial to determine the effect of mandala painting on the anxiety of coronary heart patients.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Turkey (Türkiye)

About this study

Patients in the control group will receive routine care.Patiens in the experimental group will receive routine care and mandala painting. Experimental group will paint mandala for 30 minutes/day in the evenings for six consecutive days. In order not to interrupt the duties of the nurse and doctor in the clinic, it was planned for the experimental group to paint mandalas in the evening. Six pre-selected mandalas were planned to be printed separately on A4 paper. Each patient will be given a new mandala each day. At the beginning of the study, six colors will be given to the experimental group (yellow, blue, green, red, purple, brown). It was planned to do it for 6 days, as it was found that painting mandala for more than a week in the studies could reduce the patient's attention. In addition, based on the average hospitalization days of the patients, reaching patients for more than a week will be a problem.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mandala

Device

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 names: Mandala Painting

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

The Effect of Mandala Painting on Anxiety in Coronary Heart Patients: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2022
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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