The Effect of Mandala Coloring on Perinatal Grief and Psychological Resilience Levels in Women Experiencing Perinatal Loss: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Perinatal Grief
研究概览
简要总结
The goal of this clinical trial is to evaluate if mandala colouring helps to decrease grief symptoms and increase resilience in women who experienced perinatal loss.
The main questions are:
Does mandala coloring decrease perinatal grief symptoms? Does mandala coloring increase resilience?
Researchers will compare mandala coloring intervention with standard perinatal loss nursing care to evaluate if mandala coloring works to decrease grief symptoms.
Participants will:
Answer some questionnaires and scales, and do mandala coloring at least for 20 minutes for 10 days after perinatal loss experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Experienced perinatal loss (neonatal death, fetal death, abortion) within the last six weeks
排除标准
- •Serious psychological problem that requires intervention with the recommendation of a psychiatrist, such as having a previous mental disorder or use of antidepressants.
- •Practicing alternative methods such as yoga, meditation, acupuncture
研究组 & 干预措施
Intervention
This arm will have mandala coloring intervention
干预措施: Mandala Coloring (Other)
Control
This arm will not receive any intervention
结局指标
主要结局
Perinatal Grief
时间窗: 1st day to 10th day
Perinatal Grief will be assessed via Perinatal Grief Scale. The scale is a 5-point Likert-type scale and responses range from "strongly agree to strongly disagree". The scale includes three sub-dimensions: "active grief", "difficulty coping" and "hopelessness". The total number of items in the scale is 32. Items 11 and 32 of the scale have a positive sentence structure. These items are answered in reverse. While the total grief score that can be obtained from the scale varies between 32-160, the scores that can be obtained for each sub-dimension seperately. As the total perinatal grief score and the total score obtained from the sub-dimensions increase, it is determined that the individual's grief level is higher.
Perinatal Grief Intensity
时间窗: 1st day to 10th day
Will be assessed via Perinatal Grief Intensity Scale. The scale consists of 14 items, rated on a 4-point Likert-type scale from strongly agree to strongly disagree, and three sub-dimensions: "reality", "confrontation with others", and "adaptation". The scale contains both positive and negative expressions. Therefore, items 1, 2, 3, and 6 are evaluated as reverse items in the scoring of the scale. When calculating the scores of the sub-dimensions, the score obtained from each item is added up and divided by the number of items in the sub-dimension. Thus, a total score between 1 and 4 is obtained from each sub-dimension. The following formula is used for the total score: 3.08 + (0.41 x reality sub-dimension mean score) - (0.2 x confrontation sub-dimension mean score) - (0.15 x harmony sub-dimension mean score) The score that can be obtained from the scale varies between 2.09 - 4.37. It is predicted that the intensity of grief that will be experienced increases as the score increases
Perinatal Grief
时间窗: 1st day to 10th day
Perinatal Grief will be assessed via Perinatal Grief Scale. The scale is a 5-point Likert-type scale and responses range from "strongly agree to strongly disagree". The scale includes three sub-dimensions: "active grief", "difficulty coping" and "hopelessness". The total number of items in the scale is 32. Items 11 and 32 of the scale have a positive sentence structure. These items are answered in reverse. While the total grief score that can be obtained from the scale varies between 32-160, the scores that can be obtained for each sub-dimension seperately. As the total perinatal grief score and the total score obtained from the sub-dimensions increase, it is determined that the individual's grief level is higher.
Perinatal Grief Intensity
时间窗: 1st day to 10th day
Will be assessed via Perinatal Grief Intensity Scale. The scale consists of 14 items, rated on a 4-point Likert-type scale from strongly agree to strongly disagree, and three sub-dimensions: "reality", "confrontation with others", and "adaptation". The scale contains both positive and negative expressions. Therefore, items 1, 2, 3, and 6 are evaluated as reverse items in the scoring of the scale. When calculating the scores of the sub-dimensions, the score obtained from each item is added up and divided by the number of items in the sub-dimension. Thus, a total score between 1 and 4 is obtained from each sub-dimension. The following formula is used for the total score: 3.08 + (0.41 x reality sub-dimension mean score) - (0.2 x confrontation sub-dimension mean score) - (0.15 x harmony sub-dimension mean score) The score that can be obtained from the scale varies between 2.09 - 4.37. It is predicted that the intensity of grief that will be experienced increases as the score increases
次要结局
- Resilience(1st day and 10th day)
- Resilience(1st day and 10th day)
研究者
Elif Balkan
Research Assistant
University of Yalova