Reiki for Women Undergoing Breast Surgery
This study is looking at how Medical Reiki©, a type of energy therapy, might help women who are having breast cancer surgery. Reiki involves light touch to target energy fields around your body, which is believed to help your body heal itself. Researchers want to see if Medical Reiki© can improve your well-being and recovery after surgery. You might be able to join if you are a woman between 18 and 99 years old, have been diagnosed with breast cancer (stages 0-III), and are having a mastectomy within two weeks of joining the study. The study aims to see if it's practical to conduct this type of research and how many eligible patients are interested in participating. The current recruitment status is unclear.
- Study design
- This is a pilot study that will randomly assign 32 women to receive either Medical Reiki© or Sham Reiki, where a non-Reiki healer mimics the treatment. It is a double-blind study, meaning neither you nor the researchers will know which treatment you are receiving.
- What's involved
- You would receive a pre-operative Reiki intervention. The study includes a follow-up period of two months after the intervention.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for two months after the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Reiki Breast Surgery QOL Project for Women Undergoing Breast Surgery
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Alyson Moadel, PhD · PRINCIPAL_INVESTIGATOR · Albert Einstein College of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Feasibility based on Number Screened for Inclusion2 months
The total number of patients screened for inclusion will be summarized and reported.
- Feasibility - Percentage of Patients who met Inclusion Criteria2 months
The number/percentage of patients who met inclusion criteria will be summarized and reported.
- Feasibility - Percentage of Patients who Assented for Informed Consent2 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 Procedure2 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 Participate2 months
The number/percentage of patients who agreed/refused to Participate will be summarized and reported.
- Feasibility - Percentage of Patients who Completed Baseline Assessments2 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 Arm2 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 Intervention2 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 Visits2 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 Assessments2 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 Assessments2 months
The number/percentage of patients who were Unmasked during End Line Assessments will be summarized and reported.
- Feasibility - Retention Rate2 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 FidelityImmediately 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 FidelityImmediately 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)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).