Reiki Breast Surgery QOL Project for Women Undergoing Breast Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical Reiki, Sham Reiki.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 99 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study of Medical Reiki for Women Undergoing Surgery for Breast Cancer: Impact on Quality of Life, Medical Recovery Metrics, and Cortisol
Overview
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.
Interventions
- Other Medical Reiki
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. - Other Sham Reiki
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.
Primary outcome measures
- Feasibility based on Number Screened for Inclusion [Time frame: 2 months]
- Feasibility - Percentage of Patients who met Inclusion Criteria [Time frame: 2 months]
- Feasibility - Percentage of Patients who Assented for Informed Consent [Time frame: 2 months]
- Feasibility - Percentage of Patients who Completed the Informed Consent Procedure [Time frame: 2 months]
- Feasibility - Percentage of Patients who Agreed and Refused to Participate [Time frame: 2 months]
- Feasibility - Percentage of Patients who Completed Baseline Assessments [Time frame: 2 months]
- Feasibility - Percentage of Patients who were Randomly Allocated as per allocation list to Treatment Arm [Time frame: 2 months]
- Feasibility - Percentage of Patients who Received Intended Intervention [Time frame: 2 months]
- Feasibility - Percentage of Patients who Dropped out during Follow-up Visits [Time frame: 2 months]
- Feasibility - Percentage of Patients who Completed all End Line Assessments [Time frame: 2 months]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Current, uncontrolled psychiatric co-morbidities
- Pregnant women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Montefiore Medical Center — The Bronx
Identifiers
NCT: NCT06524895 · 2022-14017 · MRW-22-0001