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Bone Marrow Transplant ComplicationsNCT05694910

Reiki Effects on Bone Marrow Transplant Patients

A study testing Reiki in people with Bone Marrow Transplant Complications and Fatigue, run by Ankara Medipol University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Reiki
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2022to 1 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting
  • Nursemin Ünal

    Ankara, None Selected, 06050

    Nursemin Unal, 05077433629, nurse_unal@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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

Read the 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.

Being tested
Reiki
Keywords
Reiki, Fatigue, Vital signs, Engraftment, Bone marrow transplant patients
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReikiOther

    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.

Study groups in NCT05694910
Study groupRoleWhat they receive
Reiki GroupExperimentalPersonal 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.
Receives: Other: Reiki
Control GroupNo interventionPersonal 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Personal Information Form

    There are questions to determine the soci-demographic features and the characteristics of the disease/treatment process.

    Measured: Baseline

  2. 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.

    Measured: Change from baseline Visual Analog Scale at one week

  3. 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.

    Measured: Change from fatigue level at a week

  4. Engraftment

    Engraftment is when the transplanted stem cells grow and produce new blood cells at levels that can be counted in the bloodstream.

    Measured: After one week

  5. Change from Leukocyte values at a week

    They are the leading elements of the body's defense system.

    Measured: Change from Leukocyte values at a week

  6. 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.

    Measured: Change from Hemoglobin values at a week

  7. 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.

    Measured: Change from Hematocrit values at a week

  8. Change from Erythrocyte values at a week

    The erythrocyte contains hemoglobin, which is involved in the transport of oxygen in the body.

    Measured: Change from Erythrocyte values at a week

  9. Change from heart rate values at a week

    The number of times the heart beats per minute is the heart rate.

    Measured: Change from heart rate values at a week

  10. 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.

    Measured: Change from systolic and diastolic blood pressure values at a week

  11. 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.

    Measured: Change from body temperature values at a week

  12. Change from respiratory rate values at a week

    At rest, the respiratory rate of an adult should be 12-20/min.

    Measured: Change from respiratory rate values at a week

  13. Change from oxygen saturation values at a week

    Oxygen saturation refers to the oxygen saturation in the blood.

    Measured: Change from oxygen saturation values at a week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2023
  2. Study start1 Aug 2022
  3. Primary completion28 Feb 2023 (estimated)
  4. Study completion1 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05694910
Sponsor's protocol ID
113
Status last verified
Jan 2023
First submitted
7 Jan 2023
Last updated
23 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 31231381
  • 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.

    PubMed 33989413
  • 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.

    PubMed 12832954
  • 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.

    PubMed 22699091
  • 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.

    PubMed 12564350
  • 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.

    PubMed 34139388
  • 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.

    PubMed 26906139

Questions about this trial

What is this clinical trial studying?

A study testing Reiki in people with Bone Marrow Transplant Complications and Fatigue, run by Ankara Medipol University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nursemin Unal (+905077433629, nurse_unal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Personal Information Form (time frame: Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05694910, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.

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