Healing Touch Intervention in Post-Cardiac Event Patients Prior to Starting a Cardiac Rehab Program
试验速览
- 阶段
- 不适用
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Number of participants with an improvement in stress and anxiety symptoms as measured by Dartmouth Quality of Life Index scores
研究概览
简要总结
The purpose of the investigators proposed randomized, controlled study is to examine the effect of 6 one hour treatments of Healing Touch (HT) over 3 weeks on post-cardiac event patients, while they wait to enter a Cardiac Rehab (CR) program.Patients enrolled in the Scripps Center for Integrative Medicine (SCIM) Cardiac Rehab Program typically experience a waiting period of 3 weeks, or sometimes more, before starting the program.
Secondary aims of the proposed study are to evaluate the effect of HT on CR program outcome measures of METs, BMI, physical and mental well-being, and attendance in this population.
New participants in the CR program who qualify and agree to participate in the study will be consented and randomly assigned to the Intervention Group who will receive Healing Touch therapy, or to the Control Group, which will not receive HT.
At baseline both groups will complete the Dartmouth Quality of Life and SF-36 Health Surveys. The questionnaires will be repeated at the end of the 3 week study period and at the end of the 3 months SCIM CR program.
An effect size of 15% was chosen, with an alpha level of 0.05, 80% power, 95% confidence level, and using a two-tailed test, it was determined that a sample size of 56 patients in each group would be needed for between group comparisons. To account for potential attrition the study will enroll 124 subjects, 62 in each group.
Our rationale is that Healing Touch, in addition to standard medical care will reduce post-cardiac event stress and anxiety symptoms in patients waiting to enter a cardiac rehab program, as measured by the Dartmouth Quality of Life Index and the SF36 questionnaire. Further, the investigators suggest that Healing Touch treatments will improve patient's final outcomes of the 12 week CR program.
详细描述
Study Plan
HEALING TOUCH Healing Touch (HT) is an energy based approach to health and healing. It uses light touch to influence the energy field that surrounds the body, and energy centers which control the flow of energy to the physical body. HT can restore harmony and balance, which can affect all physical, mental, emotional, and spiritual health, as well as self-healing. HT complements traditional health care and is used together with other approaches to health and healing.
Healing touch has been studied for use in pain, cancer, endocrine-immune-HIV, mental health, and cardiovascular factors in patients ranging from pediatric to the elderly.
POST-CARDIAC EVENT STRESS AND ANXIETY SYMPTOMS Having a major cardiac event can be a stressful, life changing occurrence. Often, the psychological impacts of having a heart attack (myocardial infarction) are underestimated and can be long lasting. In fact, there is evidence to suggest that the emotional stressors that occur post-MI are consistent with symptoms of post-traumatic stress disorder (PTSD), which has been shown to be associated with higher rates of recurrent coronary events and overall increased mortality in diagnosed patients.
Studies have shown that mental stress has a negative effect on a person's heart health. In particular:
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have referral to Cardiac Rehab at the Scripps Center for Integrative Medicine.
- •Must have had a cardiac event which precede the CR referral.
- •Must be willing to come to the Scripps Center for Integrative Medicine twice a week for 3 weeks.
- •Must be able to understand English
排除标准
- •Patients under 18 years.
- •Unable to understand English
研究组 & 干预措施
Intervention Group
This group will receive 6 Healing Touch treatments over 3 weeks
干预措施: Healing Touch (Other)
Control Group[
This group will continue with their usual medical treatments but receive NO Healing Touch
结局指标
主要结局
Number of participants with an improvement in stress and anxiety symptoms as measured by Dartmouth Quality of Life Index scores
时间窗: 3 weeks
Dartmouth Quality of Life Index questionnaires will be obtained at enrollment and after 3 weeks of HT (or no intervention for the control group).
Number of participants with an improvement in stress and anxiety symptoms as measured by SF-36 scores
时间窗: 3 weeks
SF-36 questionnaires will be obtained at enrollment and after 3 weeks of HT (or no intervention for the control group).
次要结局
- Number of participants with an improvement in stress and anxiety symptoms as measured by Dartmouth Quality of Life Index scores(3 months)
- Number of participants with an improvement in BMI: Body Mass Index(3 months)
- Number of cardiac rehab sessions each participant attended will be recorded(3 months)
- Number of participants with an improvement of Metabolic Equivalent of Task (MET)(3 months)
- Number of participants with an improvement in stress and anxiety symptoms as measured by SF-36 scores(3 months)