Reiki Effects on Bone Marrow Transplant Patients

NCT05694910 | Unknown

• 1 other identifier: 113
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Marrow Transplant Complications; Fatigue; Vital Signs; Reiki

Keywords

Reiki; Fatigue; Vital signs; Engraftment; Bone marrow transplant patients

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (2)

Reiki Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Reiki OTHER

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.

Reiki Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Medipol University: lead

Study Sites (1)

Nursemin Ünal

Ankara, None Selected, 06050, Turkey (Türkiye)

RECRUITING

Related Publications (7)

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

  PMID: 31231381 BACKGROUND

• 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.

  PMID: 33989413 BACKGROUND

• 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.

  PMID: 12832954 BACKGROUND

• 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.

  PMID: 22699091 BACKGROUND

• 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.

  PMID: 12564350 BACKGROUND

• 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.

  PMID: 34139388 BACKGROUND

• 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.

  PMID: 26906139 BACKGROUND

MeSH Terms

Conditions

Fatigue

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Nilay BEKTAS AKPINAR

  Ankara Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nursemin Unal

CONTACT

+905077433629; nurse_unal@hotmail.com

Nilay Bektaş Akpınar

CONTACT

+905319920260; nilay.bektasakpinar@ankaramedipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 7, 2023
• First Posted: January 23, 2023
• Study Start: August 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: April 1, 2023
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)