Reiki Effects on Bone Marrow Transplant Patients

Study Overview
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Brief Summary
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The aim of the study is to examine the effect of Reiki on fatigue, vital signs, and engraftment in bone marrow transplant patients.

Detailed Description
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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.

Official Title
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The Effect of Reiki on Fatigue, Vital Signs and Engraftment in Bone Marrow Transplant Patients

Conditions
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Bone Marrow Transplant Complications, Fatigue, Vital Signs, Reiki

Intervention / Treatment
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* Other: Reiki


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reiki Group<br>Personal Information Form (PIF), Visual Analog Scale (VAS), and National Cancer Institute (NCI) -Common Terminology Criteria for Adverse Events (CTCAE) will be administered to the patients. Then vital signs and laboratory findings will be recorded. After the protests will be completed, the primary investigator with Reiki second degree 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. Post-tests will be applied to all patients after one week and vital signs and laboratory findings will be recorded. | Other: Reiki<br>* Reiki has based on the belief that disease occurs when an energy center is blocked, and that the energy is transmitted through touch. In distance Reiki, Reiki practitioners followed the traditional Usui Reiki protocol healing.<br>|
| No Intervention: Control Group<br>Personal Information Form (PIF), Visual Analog Scale (VAS), and National Cancer Institute (NCI) -Common Terminology Criteria for Adverse Events (CTCAE) will be administered to the patients. Then vital signs and laboratory findings will be recorded. After a week, the posttest will be applied to the patients and vital signs and laboratory findings will be recorded. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal Information Form | There are questions to determine the soci-demographic features and the characteristics of the disease/treatment process. | Baseline | 
| Visual Analog Scale | 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. | Change from baseline Visual Analog Scale at one week | 
| Fatigue | 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 fatigue level at a week | 
| Engraftment | Engraftment is when the transplanted stem cells grow and produce new blood cells at levels that can be counted in the bloodstream. | After one week | 
| Change from Leukocyte values at a week | They are the leading elements of the body's defense system. | Change from Leukocyte values at a week | 
| 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. | Change from Hemoglobin values at a week | 
| 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 Hematocrit values at a week | 
| Change from Erythrocyte values at a week | The erythrocyte contains hemoglobin, which is involved in the transport of oxygen in the body. | Change from Erythrocyte values at a week | 
| Change from heart rate values at a week | The number of times the heart beats per minute is the heart rate. | Change from heart rate values at a week | 
| 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 systolic and diastolic blood pressure values at a week | 
| 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 body temperature values at a week | 
| Change from respiratory rate values at a week | At rest, the respiratory rate of an adult should be 12-20/min. | Change from respiratory rate values at a week | 
| Change from oxygen saturation values at a week | Oxygen saturation refers to the oxygen saturation in the blood. | Change from oxygen saturation values at a week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reiki, Fatigue, Vital signs, Engraftment, Bone marrow transplant patients