Breast CancerNCT06524895
Reiki Breast Surgery QOL Project for Women Undergoing Breast Surgery
A study testing Medical Reiki in people with Breast Cancer, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
This pilot study will examine the impact of pre-operative Medical Reiki© on the psychosocial well-being and recovery of underserved women undergoing breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Medical Reiki
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2022to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-99
- Breast Cancer Diagnosis Stage 0-III
- Undergoing unilateral or bilateral mastectomy (with or without reconstruction) within 2 weeks of recruitment
- English Speaking
- From within 50 miles of Bronx County, NY
Who cannot join
- Current, uncontrolled psychiatric co-morbidities
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
Alyson Moadel, PhD, 718-430-2696, alyson.moadel-robblee@einsteinmed.edu
About this study
Official title: Pilot Study of Medical Reiki for Women Undergoing Surgery for Breast Cancer: Impact on Quality of Life, Medical Recovery Metrics, and Cortisol
This pilot study will examine the impact of pre-operative Medical Reiki© on the psychosocial well-being and recovery of underserved women undergoing breast cancer surgery.
Read the detailed description
Reiki is a form of energy therapy involving the facilitation of healing through the manipulation of biofields utilizing light touch. Practitioners lightly place their hands directly on or above the patient's body to transmit energy from the practitioner to the recipient. This process of targeting the energy fields around the patient's body is believed to stimulate the patient's natural ability to heal itself. Reiki is a safe treatment modality that emphasizes spirituality in healing and wellness whose origins are rooted in ancient Tibetan traditions. The prevalence of integrating complementary therapies such as Reiki into mainstream medical practices is demonstrated by the number of hospitals that make use of these therapies to help alleviate, for example, the fatigue, pain, anxiety, and diminished quality of life experienced by cancer patients and those with other illnesses. Reiki in particular, has become more widespread in cancer centers because of its potential to reduce cancer-related symptoms and enhanced wellness without posing harm to patients.
A pilot double-blind randomized-controlled design will be used to engage 32 women in a pre-operative Reiki intervention designed by Raven Keyes called Medical Reiki© with a follow-up of two months. Women diagnosed with stage I-III breast cancer undergoing mastectomy for their treatment will be recruited to study within two weeks of surgery. Patients will be recruited to receive Medical Reiki© vs Sham Reiki (attention control) before surgery, with medical and psychosocial outcomes assessment conducted at three time points: -T0 - Baseline/pre-surgery; T1 (1-month); T2 (2 months). These assessments will either be self-administered or administered via telephone by the research team. The study The study will aim to determine the feasibility of offering Medical Reiki to breast cancer patients immediately prior to breast surgery; the impact of pre-operative Medical Reiki© vs Sham Reiki on post-operative recovery at the identified timepoints based on the specified measures of Subjective QoL metrics and objective recovery metrics.
- Conditions
- Breast Cancer
- Being tested
- Medical Reiki, Sham Reiki
- Keywords
- Reiki
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical ReikiOther
Reiki is a form of energy therapy involving the facilitation of healing through the manipulation of biofields utilizing light touch. It is a process of targeting the energy fields around the patient's body is believed to stimulate the patient's natural ability to heal itself.
Sham ReikiOther
Sham Reiki involves a non-Reiki healer who mimics the treatment of a Reiki healer. Sham Reiki providers will be medical students who are not interested and without prior knowledge or experience with Reiki Medicine.The medical students will not have any prior experience in Reiki healing or associated energy healing modalities. It is better for this project if the medical student has no interest so there is true placebo effect being monitored.
| Study group | Role | What they receive |
|---|---|---|
| Group A- Medical Reiki | Active comparator | The energy medicine will be delivered to the study participant immediately pre-op. The Reiki practitioner will hold the participant's hand for 10 minutes. This will be followed by touching the participant's upper arm along with shoulder for 20 minutes. Clinical staff will ask standard questions to assess mood while receiving the energy medicine. Because this is a medical study, the practitioner will mainly be silent for the 30 minute session. Receives: Other: Medical Reiki |
| Group B- Sham Reiki | Sham comparator | Patients will be recruited to receive "Sham" Reiki before surgery. The non-Reiki healer will hold the participant's hand for 10 minutes. This will be followed by touching the participant's upper arm along with shoulder for 20 minutes. Clinical staff will ask standard questions to assess mood while receiving the energy medicine. Because this is a medical study, the non-Reiki healer will mainly be silent for the 30 minute session. Receives: Other: Sham Reiki |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility based on Number Screened for Inclusion
The total number of patients screened for inclusion will be summarized and reported.
Measured: 2 months
Feasibility - Percentage of Patients who met Inclusion Criteria
The number/percentage of patients who met inclusion criteria will be summarized and reported.
Measured: 2 months
Feasibility - Percentage of Patients who Assented for Informed Consent
The number/percentage of patients who assented for Informed Consent will be summarized and reported.
Measured: 2 months
Feasibility - Percentage of Patients who Completed the Informed Consent Procedure
The number/percentage of patients who completed the Informed Consent Procedure will be summarized and reported.
Measured: 2 months
Feasibility - Percentage of Patients who Agreed and Refused to Participate
The number/percentage of patients who agreed/refused to Participate will be summarized and reported.
Measured: 2 months
Feasibility - Percentage of Patients who Completed Baseline Assessments
The number/percentage of patients who completed baseline assessments will be summarized and reported.
Measured: 2 months
Feasibility - Percentage of Patients who were Randomly Allocated as per allocation list to Treatment Arm
The number/percentage of patients who who were Randomly Allocated as per allocation list to Treatment Arm will be summarized and reported.
Measured: 2 months
Feasibility - Percentage of Patients who Received Intended Intervention
The number/percentage of patients who received the intended intervention will be summarized and reported.
Measured: 2 months
Feasibility - Percentage of Patients who Dropped out during Follow-up Visits
The number/percentage of patients who dropped out during follow-up Visits will be summarized and reported.
Measured: 2 months
Feasibility - Percentage of Patients who Completed all End Line Assessments
The number/percentage of patients who completed all end Line assessments will be summarized and reported.
Measured: 2 months
Feasibility - Percentage of Patients who were Unmasked during End Line Assessments
The number/percentage of patients who were Unmasked during End Line Assessments will be summarized and reported.
Measured: 2 months
Feasibility - Retention Rate
Feasibility will be assessed based on retention of study patients in the study arms. For this study retention rate will be determined per study arm and will be equal to the ratio (in percentage) of the number of patients who completed all study activities at two months to the number of patients assigned to that study arm. For this study a retention rate of 80% is targeted.
Measured: 2 months post-operatively
Provider Fidelity
Provider fidelity will be assessed based upon responses to a Reiki Fidelity Provider Survey administered immediately after the intervention session. The survey consists of 11 questions (including one question which contains three sub-questions). For purposes of assessing Provider Fidelity only the first three questions on the survey are scored. For these three questions, providers are asked to identify a score on an 11-point Likert scale ranging from 0 (either "Not at all" or "Uncomfortable") to 10 (either "Completely" or "Very Comfortable") as to the conduct of the intervention, the degree of comfort they felt, and the degree of comfort providers perceived that their patients felt, during the session, for an overall possible scoring range of 0-30. Higher scores associated with and increased level of provider fidelity. Overall scores will be summarized at each time point using basic descriptive statistics.
Measured: Immediately after intervention (before surgery), up to 1 hour
Patient Fidelity
Patient fidelity will be assessed based upon responses to a Reiki Fidelity Patient Survey administered immediately following the intervention session. The survey consists of 8 questions; however, for purposes of assessing Patient Fidelity only questions 1, 2, 6, and 7 on the survey are scored. For these four questions, patients are asked to identify a score on an 11-point Likert scale ranging from 0 (either "Very Negative", "Uncomfortable", or "Not at all") to 10 (either "Very Positive", "Very Comfortable", or "Very Much") as to their experience with the intervention, their level of comfort with the intervention and their expectations as to the impact on physical and emotional recovery derived from the intervention, for an overall possible scoring range of 0-40. Higher scores associated with and increased level of patient fidelity. Overall scores will be summarized at each time point using basic descriptive statistics.
Measured: Immediately after intervention (before surgery), up to 1 hour
Change in Mood States (Quality of Life)
Change in mood states will be assessed using the Profile of Mood States (POMS) Inventory-Short form. POMS is an 11-item checklist of mood states which assesses psychological distress including tension, depression, and fatigue. The questionnaire consists of a list of adjectives and asks patients to provide a score best describing feelings associated with each particular adjective (mood state) over the past week based on a 5 point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely"), yielding an overall possible scoring range of 0-44. Overall scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with an increased level of distress and negative mood states (including tension, depression, fatigue).
Measured: Baseline, 1 month post-operatively, 2 month post-operatively
Secondary outcomes (8)
Stressful Life Events
Stressful life events will be assessed using the List of Threatening Experiences - Questionnaire (LTE-Q). The LTE-Q is a 12-item survey used to assess acute stressful events that could influence quality of life and cortisol outcomes. Patients are provided with 12 questions and asked to provide a binary (Yes/No) response as to whether each event was experienced over the prior 12 month period. "No" responses are assigned a value of 0 and "Yes" responses are assigned a value of 1. Item scores are summed to derive a total score with an overall possible scoring range of 0-12. Overall scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with an increase in stressful life events and a negative impact on quality of life.
Measured: Baseline, 1 month post-operatively, 2 month post-operatively
Religiosity
Religiosity will be assessed using the Duke University Religion Index (DUREL). The DUREL is 5-item survey that measures religious involvement in terms of public religious behavior (church activities), private behavior (praying), and intrinsic religiousness (involvement of religion in dealings in life). The first two statements ask patients about engagement with public and private religious meetings, respectively, and are scored on a scale of "1" (more than once/week; more than once/day, respectively) through "6" (never; rarely or never, respectively) based on frequency of engagement. The last three statements ask about religious beliefs/experiences based on a 5 point scale ranging from 1 ("Definitely true of me") to 5 ("Definitely not true"). Scores for the 5 statements are added for a possible overall range of 5-27. Overall scores will be summarized at each time point using basic descriptive statistics. Lower scores are associated with increased levels of religious involvement.
Measured: Baseline
Spirituality
Spirituality will be assessed using the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12). The FACIT-Sp-12 is a 12-item questionnaire which consists of statements which serve as a measure of spirituality that measures domains of meaning, peace, and faith. Patients are provided with 12 statements that people with similar illnesses have said are important and asked to provide a score indicating how true the particular statement is for them over the past 7 days, based on a 5 point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely") for an overall range of 0-48. Overall scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with an increased level of spiritual well-being.
Measured: Baseline, 1 month post-operatively, 2 month post-operatively
Pain Inventory (Quality of Life)
Pain Severity and Pain Interference will be assessed using the Brief Pain Inventory Short Form (BPI-SF). BPI-SF consists of statements that assess the severity of pain and its impact on functioning in patients with chronic illnesses. The BPI-SF uses a 0-10 numeric rating scale for item rating for 2 subscales: Pain Severity (4 items) and Pain Interference (7 items). Patients provide a Pain Severity score between 0 ("No Pain") and 10 ("Pain as bad as you can imagine") and a mean of the 4 severity items on the BPI-SF is determined. Similarly, patients are asked to provide a Pain Interference score between 0 ("Does not Interfere") and 10 ("Completely interferes") and a mean of the 7 interference items is determined. The two subscales are added for an overall possible range of 0-110. Overall scale scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with increased pain severity and an adverse impact on daily life function.
Measured: Baseline, 1 month post-operatively, 2 month post-operatively
Cancer Behavior (Quality of Life)
Cancer behavior assessing four major constructs: maintaining independence; participating in medical care; coping and stress management; and managing affect, will be assessed using the Cancer Behavior Inventory Brief Form (CBI-B) form. The CBI-B survey consists of a 12-item scale which assesses how confident the patient is in performing specific behaviors during and after cancer treatment. Patients are asked to provide a score on a 9 point scale ranging from 1 ("Not at all Confident") to 9 ("Totally confident"), for an overall possible scoring range of 12-108. Overall scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with an increased level of self-efficacy in coping with cancer.
Measured: Baseline, 1 month post-operatively, 2 month post-operatively
Blood Pressure
Blood pressure (BP) will be reported based on medical chart reviews. BP is comprised of a systolic pressure (arterial pressure during contraction) reading and a diastolic pressure (arterial pressure between heartbeats) reading, both measured in millimeters of mercury (mmHg), and reported as a single reading (systolic/diastolic). Optimal BP ranges can vary based on demographics however, in adults, elevated BP is a risk factor for adverse cardiovascular and cerebrovascular events. Group mean BP readings will be reported using basic descriptive statistics.
Measured: Baseline, 1 month post-operatively, 2 month post-operatively
Heart Rate
Heart rate (HR) will be reported in beats per minute (BPM) at rest based on medical chart reviews. Target (resting) heart rate ranges can vary based on demographics however, in adults, a lower (resting) heart rate is correlated with a higher degree of fitness and a lower incidence of cardiovascular events. Group mean HR will be reported using basic descriptive statistics.
Measured: Baseline, 1 month post-operatively, 2 month post-operatively
Respiration Rate
Respiration rate (RR) will be reported in breaths per minute (bpm) at rest based on medical chart reviews. Normal respiration rates for an adult can vary based on demographics but are generally 12-18 breaths per minute. Elevated respiration rates can be indicative of anxiety or other underlying health conditions. Group mean RR readings will be reported using basic descriptive statistics.
Measured: Baseline, 1 month post-operatively, 2 month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start9 Nov 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Model description
- Consented participants will be allocated in a 1:1 ratio between the Reiki and the Sham Reiki arms. Participants will be assigned to the intervention arms using a permuted block randomized design. Blocks of two (75%) and four (25%) will be used to randomize patients.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Reiki Works, Inc
- Responsible party
- Sponsor
- Investigators
- Alyson Moadel, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524895
- Sponsor's protocol ID
- 2022-14017
- Other IDs
- MRW-22-0001
- Status last verified
- Mar 2026
- First submitted
- 25 Jul 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Medical Reiki for Women Undergoing Surgery for Breast Cancer: Impact on Quality of Life, Medical Recovery Metrics, and Cortisol
- ClinicalTrials.gov ID
- NCT06524895
- Acronym / sponsor ID
- 2022-14017
- Conditions
- Breast Cancer
- Keywords
- Reiki
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Medical Reiki Works, Inc
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Jul 2024 (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.
This pilot study will examine the impact of pre-operative Medical Reiki© on the psychosocial well-being and recovery of underserved women undergoing breast cancer surgery.
Detailed description
Reiki is a form of energy therapy involving the facilitation of healing through the manipulation of biofields utilizing light touch. Practitioners lightly place their hands directly on or above the patient's body to transmit energy from the practitioner to the recipient. This process of targeting the energy fields around the patient's body is believed to stimulate the patient's natural ability to heal itself. Reiki is a safe treatment modality that emphasizes spirituality in healing and wellness whose origins are rooted in ancient Tibetan traditions. The prevalence of integrating complementary therapies such as Reiki into mainstream medical practices is demonstrated by the number of hospitals that make use of these therapies to help alleviate, for example, the fatigue, pain, anxiety, and diminished quality of life experienced by cancer patients and those with other illnesses. Reiki in particular, has become more widespread in cancer centers because of its potential to reduce cancer-related symptoms and enhanced wellness without posing harm to patients.
A pilot double-blind randomized-controlled design will be used to engage 32 women in a pre-operative Reiki intervention designed by Raven Keyes called Medical Reiki© with a follow-up of two months. Women diagnosed with stage I-III breast cancer undergoing mastectomy for their treatment will be recruited to study within two weeks of surgery. Patients will be recruited to receive Medical Reiki© vs Sham Reiki (attention control) before surgery, with medical and psychosocial outcomes assessment conducted at three time points: -T0 - Baseline/pre-surgery; T1 (1-month); T2 (2 months). These assessments will either be self-administered or administered via telephone by the research team. The study The study will aim to determine the feasibility of offering Medical Reiki to breast cancer patients immediately prior to breast surgery; the impact of pre-operative Medical Reiki© vs Sham Reiki on post-operative recovery at the identified timepoints based on the specified measures of Subjective QoL metrics and objective recovery metrics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Consented participants will be allocated in a 1:1 ratio between the Reiki and the Sham Reiki arms. Participants will be assigned to the intervention arms using a permuted block randomized design. Blocks of two (75%) and four (25%) will be used to randomize patients.
| Arm | Type | Receives |
|---|---|---|
| Group A- Medical Reiki | Active comparator | Other: Medical ReikiThe energy medicine will be delivered to the study participant immediately pre-op. The Reiki practitioner will hold the participant's hand for 10 minutes. This will be followed by touching the participant's upper arm along with shoulder for 20 minutes. Clinical staff will ask standard questions to assess mood while receiving the energy medicine. Because this is a medical study, the practitioner will mainly be silent for the 30 minute session. |
| Group B- Sham Reiki | Sham comparator | Other: Sham ReikiPatients will be recruited to receive "Sham" Reiki before surgery. The non-Reiki healer will hold the participant's hand for 10 minutes. This will be followed by touching the participant's upper arm along with shoulder for 20 minutes. Clinical staff will ask standard questions to assess mood while receiving the energy medicine. Because this is a medical study, the non-Reiki healer will mainly be silent for the 30 minute session. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18-99
- Breast Cancer Diagnosis Stage 0-III
- Undergoing unilateral or bilateral mastectomy (with or without reconstruction) within 2 weeks of recruitment
- English Speaking
- From within 50 miles of Bronx County, NY
Key exclusion criteria (2 listed)
- Current, uncontrolled psychiatric co-morbidities
- Pregnant women
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 |
|---|---|---|
| Medical ReikiReiki is a form of energy therapy involving the facilitation of healing through the manipulation of biofields utilizing light touch. It is a process of targeting the energy fields around the patient's body is believed to stimulate the patient's natural ability to heal itself. | Other | Group A- Medical Reiki |
| Sham ReikiSham Reiki involves a non-Reiki healer who mimics the treatment of a Reiki healer. Sham Reiki providers will be medical students who are not interested and without prior knowledge or experience with Reiki Medicine.The medical students will not have any prior experience in Reiki healing or associated energy healing modalities. It is better for this project if the medical student has no interest so there is true placebo effect being monitored. | Other | Group B- Sham Reiki |
Primary outcome
Feasibility based on Number Screened for Inclusion
Time frame: 2 months
The total number of patients screened for inclusion will be summarized and reported.
Feasibility - Percentage of Patients who met Inclusion Criteria
Time frame: 2 months
The number/percentage of patients who met inclusion criteria will be summarized and reported.
Feasibility - Percentage of Patients who Assented for Informed Consent
Time frame: 2 months
The number/percentage of patients who assented for Informed Consent will be summarized and reported.
Feasibility - Percentage of Patients who Completed the Informed Consent Procedure
Time frame: 2 months
The number/percentage of patients who completed the Informed Consent Procedure will be summarized and reported.
Feasibility - Percentage of Patients who Agreed and Refused to Participate
Time frame: 2 months
The number/percentage of patients who agreed/refused to Participate will be summarized and reported.
Feasibility - Percentage of Patients who Completed Baseline Assessments
Time frame: 2 months
The number/percentage of patients who completed baseline assessments will be summarized and reported.
Feasibility - Percentage of Patients who were Randomly Allocated as per allocation list to Treatment Arm
Time frame: 2 months
The number/percentage of patients who who were Randomly Allocated as per allocation list to Treatment Arm will be summarized and reported.
Feasibility - Percentage of Patients who Received Intended Intervention
Time frame: 2 months
The number/percentage of patients who received the intended intervention will be summarized and reported.
Feasibility - Percentage of Patients who Dropped out during Follow-up Visits
Time frame: 2 months
The number/percentage of patients who dropped out during follow-up Visits will be summarized and reported.
Feasibility - Percentage of Patients who Completed all End Line Assessments
Time frame: 2 months
The number/percentage of patients who completed all end Line assessments will be summarized and reported.
Feasibility - Percentage of Patients who were Unmasked during End Line Assessments
Time frame: 2 months
The number/percentage of patients who were Unmasked during End Line Assessments will be summarized and reported.
Feasibility - Retention Rate
Time frame: 2 months post-operatively
Feasibility will be assessed based on retention of study patients in the study arms. For this study retention rate will be determined per study arm and will be equal to the ratio (in percentage) of the number of patients who completed all study activities at two months to the number of patients assigned to that study arm. For this study a retention rate of 80% is targeted.
Provider Fidelity
Time frame: Immediately after intervention (before surgery), up to 1 hour
Provider fidelity will be assessed based upon responses to a Reiki Fidelity Provider Survey administered immediately after the intervention session. The survey consists of 11 questions (including one question which contains three sub-questions). For purposes of assessing Provider Fidelity only the first three questions on the survey are scored. For these three questions, providers are asked to identify a score on an 11-point Likert scale ranging from 0 (either "Not at all" or "Uncomfortable") to 10 (either "Completely" or "Very Comfortable") as to the conduct of the intervention, the degree of comfort they felt, and the degree of comfort providers perceived that their patients felt, during the session, for an overall possible scoring range of 0-30. Higher scores associated with and increased level of provider fidelity. Overall scores will be summarized at each time point using basic descriptive statistics.
Patient Fidelity
Time frame: Immediately after intervention (before surgery), up to 1 hour
Patient fidelity will be assessed based upon responses to a Reiki Fidelity Patient Survey administered immediately following the intervention session. The survey consists of 8 questions; however, for purposes of assessing Patient Fidelity only questions 1, 2, 6, and 7 on the survey are scored. For these four questions, patients are asked to identify a score on an 11-point Likert scale ranging from 0 (either "Very Negative", "Uncomfortable", or "Not at all") to 10 (either "Very Positive", "Very Comfortable", or "Very Much") as to their experience with the intervention, their level of comfort with the intervention and their expectations as to the impact on physical and emotional recovery derived from the intervention, for an overall possible scoring range of 0-40. Higher scores associated with and increased level of patient fidelity. Overall scores will be summarized at each time point using basic descriptive statistics.
Change in Mood States (Quality of Life)
Time frame: Baseline, 1 month post-operatively, 2 month post-operatively
Change in mood states will be assessed using the Profile of Mood States (POMS) Inventory-Short form. POMS is an 11-item checklist of mood states which assesses psychological distress including tension, depression, and fatigue. The questionnaire consists of a list of adjectives and asks patients to provide a score best describing feelings associated with each particular adjective (mood state) over the past week based on a 5 point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely"), yielding an overall possible scoring range of 0-44. Overall scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with an increased level of distress and negative mood states (including tension, depression, fatigue).
8 secondary outcomes
Stressful Life Events
Time frame: Baseline, 1 month post-operatively, 2 month post-operatively
Religiosity
Time frame: Baseline
Spirituality
Time frame: Baseline, 1 month post-operatively, 2 month post-operatively
Pain Inventory (Quality of Life)
Time frame: Baseline, 1 month post-operatively, 2 month post-operatively
Cancer Behavior (Quality of Life)
Time frame: Baseline, 1 month post-operatively, 2 month post-operatively
Blood Pressure
Time frame: Baseline, 1 month post-operatively, 2 month post-operatively
Heart Rate
Time frame: Baseline, 1 month post-operatively, 2 month post-operatively
Respiration Rate
Time frame: Baseline, 1 month post-operatively, 2 month post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- 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.
Alyson Moadel, PhD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Reiki in people with Breast Cancer, run by Albert Einstein College of Medicine 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alyson Moadel, PhD ((718)430-2696, Alyson.moadel-robblee@einsteinmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility based on Number Screened for Inclusion (time frame: 2 months). The study lists 15 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 4 Mar 2026.