Reiki Breast Surgery QOL Project for Women Undergoing Breast Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-09

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Group A- Medical Reiki

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.

Group Type ACTIVE_COMPARATOR

Medical Reiki

Intervention Type 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 B- Sham Reiki

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.

Group Type SHAM_COMPARATOR

Sham Reiki

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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