Reiki Breast Surgery QOL Project for Women Undergoing Breast Surgery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Medical Reiki, Sham Reiki.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer. Базовые параметры: 18 лет — 99 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Pilot Study of Medical Reiki for Women Undergoing Surgery for Breast Cancer: Impact on Quality of Life, Medical Recovery Metrics, and Cortisol
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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. - Другое 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.
Первичные конечные точки
- Feasibility based on Number Screened for Inclusion [Срок оценки: 2 months]
- Feasibility - Percentage of Patients who met Inclusion Criteria [Срок оценки: 2 months]
- Feasibility - Percentage of Patients who Assented for Informed Consent [Срок оценки: 2 months]
- Feasibility - Percentage of Patients who Completed the Informed Consent Procedure [Срок оценки: 2 months]
- Feasibility - Percentage of Patients who Agreed and Refused to Participate [Срок оценки: 2 months]
- Feasibility - Percentage of Patients who Completed Baseline Assessments [Срок оценки: 2 months]
- Feasibility - Percentage of Patients who were Randomly Allocated as per allocation list to Treatment Arm [Срок оценки: 2 months]
- Feasibility - Percentage of Patients who Received Intended Intervention [Срок оценки: 2 months]
- Feasibility - Percentage of Patients who Dropped out during Follow-up Visits [Срок оценки: 2 months]
- Feasibility - Percentage of Patients who Completed all End Line Assessments [Срок оценки: 2 months]
Вторичные конечные точки (8)
- Stressful Life Events [Срок оценки: Baseline, 1 month post-operatively, 2 month post-operatively]
- Religiosity [Срок оценки: Baseline]
- Spirituality [Срок оценки: Baseline, 1 month post-operatively, 2 month post-operatively]
- Pain Inventory (Quality of Life) [Срок оценки: Baseline, 1 month post-operatively, 2 month post-operatively]
- Cancer Behavior (Quality of Life) [Срок оценки: Baseline, 1 month post-operatively, 2 month post-operatively]
- Blood Pressure [Срок оценки: Baseline, 1 month post-operatively, 2 month post-operatively]
- Heart Rate [Срок оценки: Baseline, 1 month post-operatively, 2 month post-operatively]
- Respiration Rate [Срок оценки: Baseline, 1 month post-operatively, 2 month post-operatively]
Критерии участия
Критерии включения
- 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
Критерии исключения
- Current, uncontrolled psychiatric co-morbidities
- Pregnant women
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Montefiore Medical Center — The Bronx
Идентификаторы
NCT: NCT06524895 · 2022-14017 · MRW-22-0001