Pilot Study of Medical Reiki for Women Undergoing Surgery for Breast Cancer: Impact on Quality of Life, Medical Recovery Metrics, and Cortisol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Feasibility - Percentage of Patients who Completed the Informed Consent Procedure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Current, uncontrolled psychiatric co-morbidities
- •Pregnant women
研究组 & 干预措施
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.
干预措施: Medical Reiki (Other)
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.
干预措施: Sham Reiki (Other)
结局指标
主要结局
Feasibility - Percentage of Patients who Completed the Informed Consent Procedure
时间窗: 2 months
The number/percentage of patients who completed the Informed Consent Procedure will be summarized and reported.
Feasibility - Percentage of Patients who Completed Baseline Assessments
时间窗: 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
时间窗: 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
时间窗: 2 months
The number/percentage of patients who received the intended intervention will be summarized and reported.
Feasibility based on Number Screened for Inclusion
时间窗: 2 months
The total number of patients screened for inclusion will be summarized and reported.
Feasibility - Percentage of Patients who Assented for Informed Consent
时间窗: 2 months
The number/percentage of patients who assented for Informed Consent will be summarized and reported.
Feasibility - Percentage of Patients who were Unmasked during End Line Assessments
时间窗: 2 months
The number/percentage of patients who were Unmasked during End Line Assessments will be summarized and reported.
Provider Fidelity
时间窗: 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
时间窗: 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.
Feasibility - Percentage of Patients who met Inclusion Criteria
时间窗: 2 months
The number/percentage of patients who met inclusion criteria will be summarized and reported.
Feasibility - Percentage of Patients who Agreed and Refused to Participate
时间窗: 2 months
The number/percentage of patients who agreed/refused to Participate will be summarized and reported.
Feasibility - Percentage of Patients who Completed all End Line Assessments
时间窗: 2 months
The number/percentage of patients who completed all end Line assessments will be summarized and reported.
Feasibility - Percentage of Patients who Dropped out during Follow-up Visits
时间窗: 2 months
The number/percentage of patients who dropped out during follow-up Visits will be summarized and reported.
Feasibility - Retention Rate
时间窗: 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.
Change in Mood States (Quality of Life)
时间窗: 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).
次要结局
- Stressful Life Events(Baseline, 1 month post-operatively, 2 month post-operatively)
- Religiosity(Baseline)
- Heart Rate(Baseline, 1 month post-operatively, 2 month post-operatively)
- Spirituality(Baseline, 1 month post-operatively, 2 month post-operatively)
- Pain Inventory (Quality of Life)(Baseline, 1 month post-operatively, 2 month post-operatively)
- Cancer Behavior (Quality of Life)(Baseline, 1 month post-operatively, 2 month post-operatively)
- Blood Pressure(Baseline, 1 month post-operatively, 2 month post-operatively)
- Respiration Rate(Baseline, 1 month post-operatively, 2 month post-operatively)