The Effect of Mandala Painting on Anxiety in Coronary Heart Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The Hospital Anxiety and Depression Scale
研究概览
简要总结
This study was planned as a randomized controlled trial to determine the effect of mandala painting on the anxiety of coronary heart patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
It was planned to use block randomization for the random assignment of patients to the experimental and control groups.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
The Hospital Anxiety and Depression Scale
时间窗: 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.
次要结局
未报告次要终点
研究者
Gülşah Çamcı
Assistant Prof
Marmara University