Clinical trial NCT05694910: Reiki Effects on Bone Marrow Transplant Patients
Official title: The Effect of Reiki on Fatigue, Vital Signs and Engraftment in Bone Marrow Transplant Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Marrow Transplant Complications
Fatigue
Vital Signs
Reiki
Keywords: Reiki
Fatigue
Vital signs
Engraftment
Bone marrow transplant patients
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Personal Information Form
timeFrame: Baseline
measure: Visual Analog Scale
timeFrame: Change from baseline Visual Analog Scale at one week
measure: Fatigue
timeFrame: Change from fatigue level at a week
measure: Engraftment
timeFrame: After one week
measure: Change from Leukocyte values at a week
timeFrame: Change from Leukocyte values at a week
measure: Change from Hemoglobin values at a week
timeFrame: Change from Hemoglobin values at a week
measure: Change from Hematocrit values at a week
timeFrame: Change from Hematocrit values at a week
measure: Change from Erythrocyte values at a week
timeFrame: Change from Erythrocyte values at a week
measure: Change from heart rate values at a week
timeFrame: Change from heart rate values at a week
measure: Change from systolic and diastolic blood pressure values at a week
timeFrame: Change from systolic and diastolic blood pressure values at a week
measure: Change from body temperature values at a week
timeFrame: Change from body temperature values at a week
measure: Change from respiratory rate values at a week
timeFrame: Change from respiratory rate values at a week
measure: Change from oxygen saturation values at a week
timeFrame: Change from oxygen saturation values at a week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Nursemin Ünal
state: None Selected
Study officials:
affiliation: Ankara Medipol University
name: Nilay BEKTAS AKPINAR
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Cohen MZ, Rozmus CL, Mendoza TR, Padhye NS, Neumann J, Gning I, Aleman A, Giralt S, Cleeland CS. Symptoms and quality of life in diverse patients undergoing hematopoietic stem cell transplantation. J Pain Symptom Manage. 2012 Aug;44(2):168-80. doi: 10.1016/j.jpainsymman.2011.08.011. Epub 2012 Jun 13.
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citation: Kelly DL, Syrjala K, Taylor M, Rentscher KE, Hashmi S, Wood WA, Jim H, Barata A, Flynn KE, Burns LJ, Shaw BE, Petersdorf E, Yero AC, Emmrich AD, Morris KE, Costanzo ES, Knight JM. Biobehavioral Research and Hematopoietic Stem Cell Transplantation: Expert Review from the Biobehavioral Research Special Interest Group of the American Society for Transplantation and Cellular Therapy. Transplant Cell Ther. 2021 Sep;27(9):747-757. doi: 10.1016/j.jtct.2021.06.007. Epub 2021 Jun 15.
citation: Mische Lawson L, Glennon C, Fiscus V, Harrell V, Krause K, Moore AB, Smith K. Effects of Making Art and Listening to Music on Symptoms Related to Blood and Marrow Transplantation. Oncol Nurs Forum. 2016 Mar;43(2):E56-63. doi: 10.1188/16.ONF.E56-E63.