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).
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
- Conditions the study is for
- Bone Marrow Transplant Complications, Fatigue, Vital Signs
- 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
- Recruiting
Nursemin Ünal
Ankara, None Selected, 06050
Nursemin Unal, 05077433629, nurse_unal@hotmail.com
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.
- Conditions
- Bone Marrow Transplant Complications, Fatigue, Vital Signs, Reiki
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
There are questions to determine the soci-demographic features and the characteristics of the disease/treatment process.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After one week
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
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
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
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
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
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
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
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
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.
- First posted23 Jan 2023
- Study start1 Aug 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bone Marrow Transplant ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURSEMIN UNAL, Ankara Medipol University
- Investigators
- Nilay BEKTAS AKPINAR, Principal investigator, Ankara Medipol University
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 31231381Abo 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 33989413So 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 12832954Cohen 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 22699091Smith 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 12564350Kelly 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 34139388Mische 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki on Fatigue, Vital Signs and Engraftment in Bone Marrow Transplant Patients
- ClinicalTrials.gov ID
- NCT05694910
- Acronym / sponsor ID
- 113
- Conditions
- Bone Marrow Transplant Complications, Fatigue, Vital Signs, Reiki
- Keywords
- Reiki, Fatigue, Vital signs, Engraftment, Bone marrow transplant patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reiki Group | Experimental | Other: ReikiPersonal 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReikiReiki 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. | Other | Reiki Group |
Primary outcome
Personal Information Form
Time frame: Baseline
There are questions to determine the soci-demographic features and the characteristics of the disease/treatment process.
Visual Analog Scale
Time frame: Change from baseline Visual Analog Scale at one week
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
Time frame: Change from fatigue level at a week
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
Time frame: After one week
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from oxygen saturation values at a week
Oxygen saturation refers to the oxygen saturation in the blood.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Background: PubMed 31231381Simpson E, Dazzi F. Bone Marrow Transplantation 1957-2019. Front Immunol. 2019 Jun 5;10:1246. doi: 10.3389/fimmu.2019.01246. eCollection 2019.
- Background: PubMed 33989413Abo 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.
- Background: PubMed 12832954So 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.
- Background: PubMed 22699091Cohen 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.
- Background: PubMed 12564350Smith 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.
- Background: PubMed 34139388Kelly 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.
- Background: PubMed 26906139Mische 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilay BEKTAS AKPINAR principal investigator
Ankara Medipol University
1 site in 1 country: see every site and its status.
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.