Reiki Breast Surgery QOL Project for Women Undergoing Breast Surgery

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorAlbert Einstein College of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Current, uncontrolled psychiatric co-morbidities

Pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medical Reiki

    Other intervention

    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.

  • Sham Reiki

    Other intervention

    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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Group A- Medical ReikiActive comparator 1 intervention
Group B: Group B- Sham ReikiSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility based on Number Screened for Inclusion

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

Time frame
2 months
2

Feasibility - Percentage of Patients who met Inclusion Criteria

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

Time frame
2 months
3

Feasibility - Percentage of Patients who Assented for Informed Consent

The number/percentage of patients who assented for Informed Consent will be summarized and reported.

Time frame
2 months
4

Feasibility - Percentage of Patients who Completed the Informed Consent Procedure

The number/percentage of patients who completed the Informed Consent Procedure will be summarized and reported.

Time frame
2 months

Secondary outcomes

1

Stressful Life Events

Stressful life events will be assessed using the List of Threatening Experiences - Questionnaire (LTE-Q). The LTE-Q is a 12-item survey used to assess acute stressful events that could influence quality of life and cortisol outcomes. Patients are provided with 12 questions and asked to provide a binary (Yes/No) response as to whether each event was experienced over the prior 12 month period. "No" responses are assigned a value of 0 and "Yes" responses are assigned a value of 1. Item scores are summed to derive a total score with an overall possible scoring range of 0-12. Overall scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with an increase in stressful life events and a negative impact on quality of life.

Time frame
Baseline, 1 month post-operatively, 2 month post-operatively
2

Religiosity

Religiosity will be assessed using the Duke University Religion Index (DUREL). The DUREL is 5-item survey that measures religious involvement in terms of public religious behavior (church activities), private behavior (praying), and intrinsic religiousness (involvement of religion in dealings in life). The first two statements ask patients about engagement with public and private religious meetings, respectively, and are scored on a scale of "1" (more than once/week; more than once/day, respectively) through "6" (never; rarely or never, respectively) based on frequency of engagement. The last three statements ask about religious beliefs/experiences based on a 5 point scale ranging from 1 ("Definitely true of me") to 5 ("Definitely not true"). Scores for the 5 statements are added for a possible overall range of 5-27. Overall scores will be summarized at each time point using basic descriptive statistics. Lower scores are associated with increased levels of religious involvement.

Time frame
Baseline
3

Spirituality

Spirituality will be assessed using the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12). The FACIT-Sp-12 is a 12-item questionnaire which consists of statements which serve as a measure of spirituality that measures domains of meaning, peace, and faith. Patients are provided with 12 statements that people with similar illnesses have said are important and asked to provide a score indicating how true the particular statement is for them over the past 7 days, based on a 5 point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely") for an overall range of 0-48. Overall scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with an increased level of spiritual well-being.

Time frame
Baseline, 1 month post-operatively, 2 month post-operatively
4

Pain Inventory (Quality of Life)

Pain Severity and Pain Interference will be assessed using the Brief Pain Inventory Short Form (BPI-SF). BPI-SF consists of statements that assess the severity of pain and its impact on functioning in patients with chronic illnesses. The BPI-SF uses a 0-10 numeric rating scale for item rating for 2 subscales: Pain Severity (4 items) and Pain Interference (7 items). Patients provide a Pain Severity score between 0 ("No Pain") and 10 ("Pain as bad as you can imagine") and a mean of the 4 severity items on the BPI-SF is determined. Similarly, patients are asked to provide a Pain Interference score between 0 ("Does not Interfere") and 10 ("Completely interferes") and a mean of the 7 interference items is determined. The two subscales are added for an overall possible range of 0-110. Overall scale scores will be summarized at each time point using basic descriptive statistics. Higher scores are associated with increased pain severity and an adverse impact on daily life function.

Time frame
Baseline, 1 month post-operatively, 2 month post-operatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Albert Einstein College of Medicine

Lead sponsor

Medical Reiki Works, Inc

Collaborator