Reiki Breast Surgery QOL Project for Women Undergoing Breast Surgery

NCT06524895 | Recruiting DMC

• 2 other identifiers: 2022-14017MRW-22-0001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Reiki

Outcome Measures

Primary Outcomes (15)

• Feasibility based on Number Screened for Inclusion

  The total number of patients screened for inclusion will be summarized and reported.

  2 months

• Feasibility - Percentage of Patients who met Inclusion Criteria

  The number/percentage of patients who met inclusion criteria will be summarized and reported.

  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.

  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.

  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.

  2 months

• Feasibility - Percentage of Patients who Completed Baseline Assessments

  The number/percentage of patients who completed baseline assessments will be summarized and reported.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  Baseline, 1 month post-operatively, 2 month post-operatively

Secondary Outcomes (8)

• Stressful Life Events

  Baseline, 1 month post-operatively, 2 month post-operatively

• Religiosity

  Baseline

• Spirituality

  Baseline, 1 month post-operatively, 2 month post-operatively

• Pain Inventory (Quality of Life)

  Baseline, 1 month post-operatively, 2 month post-operatively

• Cancer Behavior (Quality of Life)

  Baseline, 1 month post-operatively, 2 month post-operatively

Study Arms (2)

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.

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.

Other: Sham Reiki

Interventions

Medical Reiki OTHER

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.

Group A- Medical Reiki

Sham Reiki OTHER

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.

Group B- Sham Reiki

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current, uncontrolled psychiatric co-morbidities
• Pregnant women

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Medical Reiki Works, Inc: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alyson Moadel, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyson Moadel, PhD

CONTACT

(718)430-2696; Alyson.moadel-robblee@einsteinmed.edu

Camille Garrett, MPH

CONTACT

818 903 1451; camille.garrett@einsteinmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to intervention assignment so in every other aspect aside from the "energy healing", Sham practitioners should resemble the Reiki healers, and will be stratified by surgery type. Clinical staff who take objective recovery metrics will be blinded to the intervention and control arm status.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 29, 2024
• Study Start: November 9, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)