Reiki Effects on Bone Marrow Transplant Patients

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694910
• Other study ID #: 113
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: January 2023
• Source: Ankara Medipol University
• Contact: Nursemin Unal
• Phone: +905077433629
• Email: nurse_unal[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: April 1, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Transplant Complications
• Fatigue
• Reiki
• Vital Signs

Intervention

Other:
• Reiki
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.

Locations

Country	Name	City	State
Turkey	Nursemin Ünal	Ankara	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Abo S, Denehy L, Ritchie D, Lin KY, Edbrooke L, McDonald C, Granger CL. People With Hematological Malignancies Treated With Bone Marrow Transplantation Have Improved Function, Quality of Life, and Fatigue Following Exercise Intervention: A Systematic Review and Meta-Analysis. Phys Ther. 2021 Aug 1;101(8):pzab130. doi: 10.1093/ptj/pzab130. — View 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. — View 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. — View 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. — View Citation

Simpson E, Dazzi F. Bone Marrow Transplantation 1957-2019. Front Immunol. 2019 Jun 5;10:1246. doi: 10.3389/fimmu.2019.01246. eCollection 2019. — View Citation

Smith MC, Reeder F, Daniel L, Baramee J, Hagman J. Outcomes of touch therapies during bone marrow transplant. Altern Ther Health Med. 2003 Jan-Feb;9(1):40-9. — View Citation

So WK, Dodgson J, Tai JW. Fatigue and quality of life among Chinese patients with hematologic malignancy after bone marrow transplantation. Cancer Nurs. 2003 Jun;26(3):211-9; quiz 220-1. doi: 10.1097/00002820-200306000-00006. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Personal Information Form	There are questions to determine the soci-demographic features and the characteristics of the disease/treatment process.	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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