Reiki Effects on Bone Marrow Transplant Patients

NCT ID: NCT05694910

Last Updated: 2023-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-04-01

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.

Conditions

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Bone Marrow Transplant Complications Fatigue Vital Signs Reiki

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Reiki Group

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.

Group Type EXPERIMENTAL

Reiki

Intervention Type 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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Medipol University

OTHER

Sponsor Role lead

Responsible Party

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NURSEMIN UNAL

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nilay BEKTAS AKPINAR

Role: PRINCIPAL_INVESTIGATOR

Ankara Medipol University

Locations

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Nursemin Ünal

Ankara, None Selected, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Nursemin Unal

Role: CONTACT

+905077433629

Nilay Bektaş Akpınar

Role: CONTACT

+905319920260

Facility Contacts

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Nursemin Unal

Role: primary

05077433629

References

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

Reference Type BACKGROUND
PMID: 31231381 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33989413 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12832954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22699091 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12564350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34139388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26906139 (View on PubMed)

Other Identifiers

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113

Identifier Type: -

Identifier Source: org_study_id

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