Hematologic MalignancyNCT02207764
Reiki as a Complementary Therapy: A Pilot Study
A study testing Reiki in people with Hematologic Malignancy, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This research is being done to test whether a complementary intervention, Reiki therapy, can provide added benefits to the standard patient care. Reiki is method for stress reduction that uses hand positions over and/or on the body to help people relax. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Reiki
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2015
- 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
- Patients 18 and older admitted to hospital
- Speak English
- Able to give consent will be included.
Who cannot join
- Patients who are under 18
- Non-English speaking
- Unable to consent
- Pregnant women
- Unwilling to join the study will be excluded
- Intensive Care Unit (ICU) patients and those patients scheduled to receive conscious sedation will be excluded.
- Each patient may join the pilot study only once
Trial locations and contacts
1 site in 1 country.
About this study
This research is being done to test whether a complementary intervention, Reiki therapy, can provide added benefits to the standard patient care. Reiki is method for stress reduction that uses hand positions over and/or on the body to help people relax.
We are studying the effect of a 15-minute Reiki application compared to an intervention of nursing presence without Reiki. We hope to find if Reiki can assist in relieving stress, and improving patient outcomes. In the future we would like to offer complementary interventions as an adjunct to our standard care for patients.
Read the detailed description
This pilot study is designed to test if a complementary therapy, Reiki, has an effect on physiological and subjective measures of stress. This is a 2-arm randomized pilot study of the use of Reiki therapy prior to a stressful event with a convenience sample of 40 participants who are newly diagnosed hematologic malignancy patients on the inpatient service who will experience bone marrow aspirate post induction chemotherapy. Reiki therapy is a non-invasive complementary therapy that can be used in addition to the standard of care. The intervention group will receive a 15-minute Reiki session and the control group will receive 15 minutes of nursing presence. Each study arm includes a brief item questionnaire to rank subjective measures of pain, anxiety, and energy; saliva biological markers related to stress-reduction; and measures of blood pressure, heart rate, and respirations. The intervention group will receive a 15-minute intervention performed on the inpatient unit prior to the bone marrow aspirate procedure. Data will be collected from patients both before and after the intervention and before and after the bone marrow aspirate. We will collect saliva samples from the control group and baseline data including subjective measures of pain, anxiety and energy and measures of blood pressure, heart rate, and respirations. The study nurse will maintain presence in the control participant's room for 15-minutes after the initial measures.
Our research hypothesis is that there will be a change in the response to one or more parameters of physiological or subjective measures for those patients receiving a Reiki intervention when compared to those receiving standard of care plus the nurse presence in room.
The null hypothesis is there will be no difference in response between the groups.
- Conditions
- Hematologic Malignancy
- Being tested
- Reiki
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReikiBehavioural
Each study participant in the intervention group will receive one Reiki intervention by a registered nurse trained in Advanced Level Reiki through the Usui Shiki Ryoho method.
| Study group | Role | What they receive |
|---|---|---|
| Reiki Intervention | Experimental | Each study participant in the intervention group will receive one Reiki intervention by a registered nurse trained in Advanced Level Reiki through the Usui Shiki Ryoho method. Receives: Behavioral: Reiki |
| nursing presence control | No intervention | Each patient in the control group will receive usual care including the study nurse presence for the 15-minute period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress level: patient report
Explore effectiveness of Reiki therapy as an adjuvant to conventional therapy in the management of stress and anxiety. Patients will be asked their stress level on a 1-10 scale before and after the Reiki intervention.
Measured: baseline: prior to Reiki intervention
stress level: patient report
Explore effectiveness of Reiki therapy as an adjuvant to conventional therapy in the management of stress and anxiety.
Measured: post intervention: immediately after Reiki
Secondary outcomes (10)
salivary alpha amylase
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Measured: baseline
salivary alpha amylase
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Measured: post intervention (after Reiki- 15 minutes from baseline)
salivary alpha amylase
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Measured: pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)
salivary alpha amylase
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Measured: post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)
salivary alpha amylase
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Measured: 20 minutes post bone marrow biopsy
salivary cortisol
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Measured: baseline
salivary cortisol
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Measured: post intervention (after Reiki- 15 minutes from baseline)
salivary cortisol
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Measured: pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)
salivary cortisol
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Measured: post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)
salivary cortisol
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Measured: 20 minutes post bone marrow biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (estimated)
Why it stopped: competing priorities at the organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Day, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207764
- Sponsor's protocol ID
- J1358
- Other IDs
- IRB00026755
- Status last verified
- Jul 2014
- First submitted
- 29 Jul 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reiki as a Complementary Therapy: A Pilot Study
- ClinicalTrials.gov ID
- NCT02207764
- Acronym / sponsor ID
- J1358
- Conditions
- Hematologic Malignancy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: competing priorities at the organization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 4 Aug 2014 (estimated)
- 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.
This research is being done to test whether a complementary intervention, Reiki therapy, can provide added benefits to the standard patient care. Reiki is method for stress reduction that uses hand positions over and/or on the body to help people relax.
We are studying the effect of a 15-minute Reiki application compared to an intervention of nursing presence without Reiki. We hope to find if Reiki can assist in relieving stress, and improving patient outcomes. In the future we would like to offer complementary interventions as an adjunct to our standard care for patients.
Detailed description
This pilot study is designed to test if a complementary therapy, Reiki, has an effect on physiological and subjective measures of stress. This is a 2-arm randomized pilot study of the use of Reiki therapy prior to a stressful event with a convenience sample of 40 participants who are newly diagnosed hematologic malignancy patients on the inpatient service who will experience bone marrow aspirate post induction chemotherapy. Reiki therapy is a non-invasive complementary therapy that can be used in addition to the standard of care. The intervention group will receive a 15-minute Reiki session and the control group will receive 15 minutes of nursing presence. Each study arm includes a brief item questionnaire to rank subjective measures of pain, anxiety, and energy; saliva biological markers related to stress-reduction; and measures of blood pressure, heart rate, and respirations. The intervention group will receive a 15-minute intervention performed on the inpatient unit prior to the bone marrow aspirate procedure. Data will be collected from patients both before and after the intervention and before and after the bone marrow aspirate. We will collect saliva samples from the control group and baseline data including subjective measures of pain, anxiety and energy and measures of blood pressure, heart rate, and respirations. The study nurse will maintain presence in the control participant's room for 15-minutes after the initial measures.
Our research hypothesis is that there will be a change in the response to one or more parameters of physiological or subjective measures for those patients receiving a Reiki intervention when compared to those receiving standard of care plus the nurse presence in room.
The null hypothesis is there will be no difference in response between the groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reiki Intervention | Experimental | Behavioral: ReikiEach study participant in the intervention group will receive one Reiki intervention by a registered nurse trained in Advanced Level Reiki through the Usui Shiki Ryoho method. |
| nursing presence control | No intervention | –Each patient in the control group will receive usual care including the study nurse presence for the 15-minute period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 and older admitted to hospital
- Speak English
- Able to give consent will be included.
Key exclusion criteria (7 listed)
- Patients who are under 18
- Non-English speaking
- Unable to consent
- Pregnant women
- Unwilling to join the study will be excluded
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 |
|---|---|---|
| ReikiEach study participant in the intervention group will receive one Reiki intervention by a registered nurse trained in Advanced Level Reiki through the Usui Shiki Ryoho method. | Behavioural | Reiki Intervention |
Primary outcome
stress level: patient report
Time frame: baseline: prior to Reiki intervention
Explore effectiveness of Reiki therapy as an adjuvant to conventional therapy in the management of stress and anxiety. Patients will be asked their stress level on a 1-10 scale before and after the Reiki intervention.
stress level: patient report
Time frame: post intervention: immediately after Reiki
Explore effectiveness of Reiki therapy as an adjuvant to conventional therapy in the management of stress and anxiety.
10 secondary outcomes
salivary alpha amylase
Time frame: baseline
salivary alpha amylase
Time frame: post intervention (after Reiki- 15 minutes from baseline)
salivary alpha amylase
Time frame: pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)
salivary alpha amylase
Time frame: post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)
salivary alpha amylase
Time frame: 20 minutes post bone marrow biopsy
salivary cortisol
Time frame: baseline
salivary cortisol
Time frame: post intervention (after Reiki- 15 minutes from baseline)
salivary cortisol
Time frame: pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)
salivary cortisol
Time frame: post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)
salivary cortisol
Time frame: 20 minutes post bone marrow biopsy
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 23 Dec 2014.
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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.
Jennifer Day, PhD principal investigator
Johns Hopkins 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 Hematologic Malignancy, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 7 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 23 Dec 2014. 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?
stress level: patient report (time frame: baseline: prior to Reiki intervention). The study lists 2 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 23 Dec 2014.