Reiki Breast Surgery QOL Project for Women Undergoing Breast Surgery

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.

Feasibility based on Number Screened for Inclusion

Time frame: 2 months

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

Feasibility - Percentage of Patients who met Inclusion Criteria

Time frame: 2 months

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

Feasibility - Percentage of Patients who Assented for Informed Consent

Time frame: 2 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 Procedure

Time frame: 2 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 Participate

Time frame: 2 months

The number/percentage of patients who agreed/refused to Participate will be summarized and reported.

Feasibility - Percentage of Patients who Completed Baseline Assessments

Time frame: 2 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 Arm

Time frame: 2 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 Intervention

Time frame: 2 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 Visits

Time frame: 2 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 Assessments

Time frame: 2 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 Assessments

Time frame: 2 months

The number/percentage of patients who were Unmasked during End Line Assessments will be summarized and reported.

Feasibility - Retention Rate

Time frame: 2 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 Fidelity

Time frame: Immediately 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 Fidelity

Time frame: Immediately 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)

Time frame: 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).

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.