Reiki Breast Surgery QOL Project for Women Undergoing Breast Surgery

Trial Title: Reiki Breast Surgery QOL Project for Women Undergoing Breast Surgery

NCT ID: NCT06524895

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Reiki

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention 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.

Primary purpose: Supportive Care

Masking: Double (Participant, Outcomes Assessor)

Masking description: 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.

Intervention:

Intervention type: Other
Intervention name: Medical Reiki
Description: 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.
Arm group label: Group A- Medical Reiki

Intervention type: Other
Intervention name: Sham Reiki
Description: 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.
Arm group label: Group B- Sham Reiki

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.

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.

Criteria for 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 Bronx County, NY Exclusion Criteria: - Uncontrolled psychiatric co-morbidities - Pregnant women

Gender: Female

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Montefiore Medical Center

Address:
City: Bronx
Zip: 10461
Country: United States

Status: Recruiting

Contact:
Last name: Alyson Moadel, PhD

Phone: 718-430-2696
Email: alyson.moadel-robblee@einsteinmed.edu

Start date: November 9, 2022

Completion date: May 2025

Lead sponsor:
Agency: Albert Einstein College of Medicine
Agency class: Other

Collaborator:
Agency: Medical Reiki Works, Inc
Agency class: Other

Source: Albert Einstein College of Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06524895