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Reiki Effects on Bone Marrow Transplant Patients

Primary Purpose

Bone Marrow Transplant Complications, Fatigue, Vital Signs

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reiki
Sponsored by
Ankara Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bone Marrow Transplant Complications focused on measuring Reiki, Fatigue, Vital signs, Engraftment, Bone marrow transplant patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nursemin ÜnalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reiki Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Personal Information Form
There are questions to determine the soci-demographic features and the characteristics of the disease/treatment process.
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.
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.
Engraftment
Engraftment is when the transplanted stem cells grow and produce new blood cells at levels that can be counted in the bloodstream.
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
Hemoglobin is a substance found in red blood cells that makes it possible for the blood to carry oxygen throughout the body.
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
The erythrocyte contains hemoglobin, which is involved in the transport of oxygen in the body.
Change from heart rate values at a week
The number of times the heart beats per minute is the heart rate.
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 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 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
Oxygen saturation refers to the oxygen saturation in the blood.

Secondary Outcome Measures

Full Information

First Posted
January 7, 2023
Last Updated
January 19, 2023
Sponsor
Ankara Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT05694910
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Marrow Transplant Complications, Fatigue, Vital Signs, Reiki
Keywords
Reiki, Fatigue, Vital signs, Engraftment, Bone marrow transplant patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reiki Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Reiki
Intervention Description
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.
Primary Outcome Measure Information:
Title
Personal Information Form
Description
There are questions to determine the soci-demographic features and the characteristics of the disease/treatment process.
Time Frame
Baseline
Title
Visual Analog Scale
Description
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.
Time Frame
Change from baseline Visual Analog Scale at one week
Title
Fatigue
Description
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.
Time Frame
Change from fatigue level at a week
Title
Engraftment
Description
Engraftment is when the transplanted stem cells grow and produce new blood cells at levels that can be counted in the bloodstream.
Time Frame
After one week
Title
Change from Leukocyte values at a week
Description
They are the leading elements of the body's defense system.
Time Frame
Change from Leukocyte values at a week
Title
Change from Hemoglobin values at a week
Description
Hemoglobin is a substance found in red blood cells that makes it possible for the blood to carry oxygen throughout the body.
Time Frame
Change from Hemoglobin values at a week
Title
Change from Hematocrit values at a week
Description
Hematocrit refers to the ratio of the volume of red blood cells to the amount of circulating blood.
Time Frame
Change from Hematocrit values at a week
Title
Change from Erythrocyte values at a week
Description
The erythrocyte contains hemoglobin, which is involved in the transport of oxygen in the body.
Time Frame
Change from Erythrocyte values at a week
Title
Change from heart rate values at a week
Description
The number of times the heart beats per minute is the heart rate.
Time Frame
Change from heart rate values at a week
Title
Change from systolic and diastolic blood pressure values at a week
Description
Blood pressure is the pressure of the blood within the arteries of the circulatory system.
Time Frame
Change from systolic and diastolic blood pressure values at a week
Title
Change from body temperature values at a week
Description
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.
Time Frame
Change from body temperature values at a week
Title
Change from respiratory rate values at a week
Description
At rest, the respiratory rate of an adult should be 12-20/min.
Time Frame
Change from respiratory rate values at a week
Title
Change from oxygen saturation values at a week
Description
Oxygen saturation refers to the oxygen saturation in the blood.
Time Frame
Change from oxygen saturation values at a week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nursemin Unal
Phone
+905077433629
Email
nurse_unal@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nilay Bektaş Akpınar
Phone
+905319920260
Email
nilay.bektasakpinar@ankaramedipol.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilay BEKTAS AKPINAR
Organizational Affiliation
Ankara Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nursemin Ünal
City
Ankara
State/Province
None Selected
ZIP/Postal Code
06050
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nursemin Unal
Phone
05077433629
Email
nurse_unal@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31231381
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.
Results Reference
background
PubMed Identifier
33989413
Citation
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.
Results Reference
background
PubMed Identifier
12832954
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.
Results Reference
background
PubMed Identifier
22699091
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.
Results Reference
background
PubMed Identifier
12564350
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.
Results Reference
background
PubMed Identifier
34139388
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.
Results Reference
background
PubMed Identifier
26906139
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.
Results Reference
background

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Reiki Effects on Bone Marrow Transplant Patients

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