CancerNCT03946865
Reiki Therapy - an Intervention in Hematology/Oncology Cancer Patients Hospitalized
A study testing Reiki Therapy in people with Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to determine if offering and providing reiki therapy in hospitalized hematology/oncology cancer subjects has any effects on symptoms and feeling during the subjects hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- Reiki Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2019to 1 Apr 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized hematology-oncology patients age 18 - 80
- Able to speak English and complete surveys
- Able to read, understand and sign inform consent.
Who cannot join
- Patient unwilling for reiki therapy.
- Unable to give written consent.
- Already having received or receiving other reiki treatment.
- Pregnant women. (As verbalized by participant)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Reiki Therapy - an Intervention in Hematology/Oncology Cancer Patients Hospitalized in an Inpatient Setting - a Pilot Study.
Researchers are trying to determine if offering and providing reiki therapy in hospitalized hematology/oncology cancer subjects has any effects on symptoms and feeling during the subjects hospital stay.
Read the detailed description
Primary Aim:
The primary aim of this study is to evaluate the feasibility of offering and providing Reiki Therapy in hospitalized hematology/oncology cancer patients. The intervention should not - interfere with the medical management of the participants. The investigators hypothesize that Reiki Sessions will be successfully integrated into conventional care of hospitalized cancer patients.
Secondary Aim:
The secondary aim is to evaluate the patient reported outcomes of their symptoms (pain, fatigue, anxiety) and feelings (happy, energetic, relaxed, and calm) before and after Reiki Therapy. The investigators' hypothesis is that there will be improvement of patients' symptoms/feelings score after the Reiki Therapy.
- Conditions
- Cancer
- Being tested
- Reiki Therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki TherapyOther
Reiki is a healing practice that originated in Japan. Reiki practitioners place their hands lightly on or just above the person receiving treatment, with the goal of facilitating the person's own healing response.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized hematology/oncology cancer subjects | Experimental | Hospitalized hematology/oncology cancer will participate in Reiki Therapy Receives: Other: Reiki Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain pain symptoms
Measured using a numeric rating scale, where 0 is not at all and 10 is unbearable
Measured: Baseline, approximately 2 hours
Change in fatigue symptoms
Measured using a numeric rating scale, where 0 is not at all and 10 is unbearable
Measured: Baseline, approximately 2 hours
Change in anxiety symptoms
Measured using a numeric rating scale, where 0 is not at all and 10 is unbearable
Measured: Baseline, approximately 2 hours
Change in feeling happy
Measured using a numeric rating scale, where 0 is best possible and 10 is worst possible
Measured: Baseline, approximately 2 hours
Change in feeling energized
Measured using a numeric rating scale, where 0 is best possible and 10 is worst possible
Measured: Baseline, approximately 2 hours
Change in feeling relaxed
Measured using a numeric rating scale, where 0 is best possible and 10 is worst possible
Measured: Baseline, approximately 2 hours
Change in feeling calm
Measured using a numeric rating scale, where 0 is best possible and 10 is worst possible
Measured: Baseline, approximately 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start10 Jul 2019
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Why it stopped: COVID19 restrictions and study personnel retirement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent A. Bauer, Mayo Clinic
- Investigators
- Brent Bauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946865
- Sponsor's protocol ID
- 19-000456
- Status last verified
- Apr 2021
- First submitted
- 9 May 2019
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reiki Therapy - an Intervention in Hematology/Oncology Cancer Patients Hospitalized in an Inpatient Setting - a Pilot Study.
- ClinicalTrials.gov ID
- NCT03946865
- Acronym / sponsor ID
- 19-000456
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID19 restrictions and study personnel retirement
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 13 May 2019 (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.
Researchers are trying to determine if offering and providing reiki therapy in hospitalized hematology/oncology cancer subjects has any effects on symptoms and feeling during the subjects hospital stay.
Detailed description
Primary Aim:
The primary aim of this study is to evaluate the feasibility of offering and providing Reiki Therapy in hospitalized hematology/oncology cancer patients. The intervention should not - interfere with the medical management of the participants. The investigators hypothesize that Reiki Sessions will be successfully integrated into conventional care of hospitalized cancer patients.
Secondary Aim:
The secondary aim is to evaluate the patient reported outcomes of their symptoms (pain, fatigue, anxiety) and feelings (happy, energetic, relaxed, and calm) before and after Reiki Therapy. The investigators' hypothesis is that there will be improvement of patients' symptoms/feelings score after the Reiki Therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized hematology/oncology cancer subjects | Experimental | Other: Reiki TherapyHospitalized hematology/oncology cancer will participate in Reiki Therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized hematology-oncology patients age 18 - 80
- Able to speak English and complete surveys
- Able to read, understand and sign inform consent.
Key exclusion criteria (4 listed)
- Patient unwilling for reiki therapy.
- Unable to give written consent.
- Already having received or receiving other reiki treatment.
- Pregnant women. (As verbalized by participant)
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 |
|---|---|---|
| Reiki TherapyReiki is a healing practice that originated in Japan. Reiki practitioners place their hands lightly on or just above the person receiving treatment, with the goal of facilitating the person's own healing response. | Other | Hospitalized hematology/oncology cancer subjects |
Primary outcome
Change in pain pain symptoms
Time frame: Baseline, approximately 2 hours
Measured using a numeric rating scale, where 0 is not at all and 10 is unbearable
Change in fatigue symptoms
Time frame: Baseline, approximately 2 hours
Measured using a numeric rating scale, where 0 is not at all and 10 is unbearable
Change in anxiety symptoms
Time frame: Baseline, approximately 2 hours
Measured using a numeric rating scale, where 0 is not at all and 10 is unbearable
Change in feeling happy
Time frame: Baseline, approximately 2 hours
Measured using a numeric rating scale, where 0 is best possible and 10 is worst possible
Change in feeling energized
Time frame: Baseline, approximately 2 hours
Measured using a numeric rating scale, where 0 is best possible and 10 is worst possible
Change in feeling relaxed
Time frame: Baseline, approximately 2 hours
Measured using a numeric rating scale, where 0 is best possible and 10 is worst possible
Change in feeling calm
Time frame: Baseline, approximately 2 hours
Measured using a numeric rating scale, where 0 is best possible and 10 is worst possible
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Brent Bauer, MD principal investigator
Mayo Clinic
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 Therapy in people with Cancer, run by Mayo Clinic at 1 site in United States.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 3 May 2021. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain pain symptoms (time frame: Baseline, approximately 2 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2021.