The Effect of Reiki on Fatigue, Vital Signs and Engraftment in Bone Marrow Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Personal Information Form
研究概览
简要总结
The aim of the study is to examine the effect of Reiki on fatigue, vital signs, and engraftment in bone marrow transplant patients.
详细描述
Cancer is a serious and chronic disease, the number of which is increasing rapidly in our country and in the world. Today, cancer accounts for 70% of all disease diagnoses and it is estimated that the number of new cancer cases will rise to 22 million in about twenty years.
Although hematopoietic stem cell transplantation is a promising treatment for remission and complete recovery in cancer patients, the symptoms after transplantation seriously affect the quality of life of individuals. In addition to psychosocial problems, patients experience serious physical problems such as suppression of the immune system and fatigue after transplantation. Energy therapies are widely used to provide general health and well-being and to reduce or relieve the symptoms of many chronic diseases. As a result of many studies on conditions such as fatigue, pain, and anxiety, it has been determined that Reiki energy has a positive effect. When we searched the literature, it was seen that there were not enough studies examining the fatigue, vital signs, and immune systems of bone marrow transplant patients.
This randomized controlled prospective study is conducted with bone marrow transplant patients between August 2022 to February 2023. The data of the study will collect using "Personal Information Form (PIF)", "Visual Analog Scale (VAS)", and "National Cancer Institute (NCI) -Common Terminology Criteria for Adverse Events (CTCAE)". Also, vital signs and laboratory findings will be recorded.
PIF, VAS, and CTCAE will be applied to the patients who meet the inclusion criteria. Patients will be randomized 1:1 into groups to the block randomization method. There are two arms in the study; Reiki (n=21) and control group (n=21). A second-degree Reiki practitioner will apply Reiki to the patients for 30 minutes. on the second day and the third day, 30 minutes distance Reiki will be applied to the patients. In the control group, nothing will be done. Post-tests will be applied to all patients after one week and vital signs and laboratory findings will be recorded.
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 (Outcomes Assessor)
盲法说明
The patients and investigators knew which group they were assigned to. Only that outcome assessor did not know which patient was assigned to which group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being over 18 years old
- •Not having a communication problem,
- •Autologous bone marrow transplantation has been performed
- •Willingness to participate in Reiki practice,
- •To be competent to answer the data collection tools to be used in the research.
- •Not using complementary practices (energy therapies) in the last six months.
排除标准
- •Having a communication problem
- •Application of allogeneic bone marrow transplantation
- •Not being willing to engage in Reiki practice
- •Reiki practitioner or instructor,
- •Have received energy therapy sessions such as Reiki/Therapeutic touch/Healing touch in the last six months
- •Application of bone marrow transplantation for hematological cancers
结局指标
主要结局
Personal Information Form
时间窗: Baseline
There are questions to determine the soci-demographic features and the characteristics of the disease/treatment process.
Fatigue
时间窗: Change from fatigue level at a week
Common Terminology Criteria for Adverse Events (CTCAE) define adverse events experienced by cancer patients. Patients are asked to number the level of fatigue from 0 to 10. As the score increases, the severity of fatigue also increases.
Change from Leukocyte values at a week
时间窗: Change from Leukocyte values at a week
They are the leading elements of the body's defense system.
Change from Hemoglobin values at a week
时间窗: Change from Hemoglobin values at a week
Hemoglobin is a substance found in red blood cells that makes it possible for the blood to carry oxygen throughout the body.
Visual Analog Scale
时间窗: Change from baseline Visual Analog Scale at one week
It is a reliable and easily applicable scale used to measure the severity of pain in patients, accepted in the world literature. The scale, which was used to digitize the values that could not be measured numerically, was used to evaluate the pain intensity of the patients. A minimum of 0 and a maximum of 10 points can be obtained from the scale. In addition, high scores indicate increased pain intensity.
Engraftment
时间窗: After one week
Engraftment is when the transplanted stem cells grow and produce new blood cells at levels that can be counted in the bloodstream.
Change from heart rate values at a week
时间窗: Change from heart rate values at a week
The number of times the heart beats per minute is the heart rate.
Change from Hematocrit values at a week
时间窗: Change from Hematocrit values at a week
Hematocrit refers to the ratio of the volume of red blood cells to the amount of circulating blood.
Change from Erythrocyte values at a week
时间窗: Change from Erythrocyte values at a week
The erythrocyte contains hemoglobin, which is involved in the transport of oxygen in the body.
Change from body temperature values at a week
时间窗: Change from body temperature values at a week
Body temperature indicates the balance between the heat produced in the body and the heat consumed. A certain temperature is needed for the human body to continue its functions.
Change from systolic and diastolic blood pressure values at a week
时间窗: Change from systolic and diastolic blood pressure values at a week
Blood pressure is the pressure of the blood within the arteries of the circulatory system.
Change from respiratory rate values at a week
时间窗: Change from respiratory rate values at a week
At rest, the respiratory rate of an adult should be 12-20/min.
Change from oxygen saturation values at a week
时间窗: Change from oxygen saturation values at a week
Oxygen saturation refers to the oxygen saturation in the blood.
次要结局
未报告次要终点
研究者
NURSEMIN UNAL
Assistant Professor
Ankara Medipol University