跳至主要内容
临床试验/NCT04086017
NCT04086017撤回不适用

Teaching Caregivers of Hospice Patients to Administer Reiki for Symptom Management and Caregiver Support: A Feasibility Pilot Study

Ohio State University2 个研究点 分布在 1 个国家开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Establish successful enrollment of patient-caregiver dyads

研究概览

简要总结

Being a family caregiver for a patient at the end of life is both rewarding and stressful. When the end of life is nearing, caregivers may be unsure of how to help their family member. Reiki, a light touch energy therapy has been shown to increase relaxation and improve sleep quality, and decrease pain, anxiety, depressive symptoms, and medication use in both hospitalized and community-dwelling adults. This feasibility study is designed to evaluate whether teaching caregivers is feasible in addition to evaluating any benefit to FCGs and patients.

详细描述

The time a patient and family caregiver (FCG) spend together in a patient's final days is filled with emotion. Patients may turn inward and be filled with peace, or they may be bothered by symptoms. Caregivers often experience feelings of helplessness and anticipatory grief. Learning and providing a skill such as Reiki may give caregivers a way to help the patient with symptoms while at the same time feeling useful. Patient and caregiver closeness may be enhanced. Reiki has been shown to be helpful with symptoms such as pain, anxiety, depression, fatigue, and others. However, teaching caregivers of terminal hospice patients, Reiki has not been studied. The knowledge gained from this feasibility study will guide future interventions aimed at the comfort of hospice patients and FCGs.

Approximately 1.49 million Medicare beneficiaries received hospice care during 2017, and most had a FCG. During the final days or weeks, FCGs are unsure of what do or how to best help the patient when everyday caregiving actives such as physical care or nutrition are not required or no longer desired by the patient. Caregiver symptoms of depression, anxiety, or anticipatory grief increase toward the end of life along with increased patient symptoms. Having a specific skill to help the patient with symptoms or simply to show care and provide touch may empower FCGs and improve the quality of life for both caregivers and patients.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients will be eligible for the study if they are
  • ≥ 18 years old
  • receiving hospice at home.
  • Caregivers will be eligible if they are
  • ≥ 18 years old,
  • willing to complete measures, and if they are randomized to the Reiki group
  • willing to learn Reiki therapy, provide at least two Reiki therapy sessions with the patient of at least 10 minutes twice per day with at least two hours between sessions and complete one 10-minute self-Reiki session per day. Two caregivers may participate in the study.

排除标准

  • Patients will be excluded if:
  • they have a diagnosis of atrial fibrillation
  • they have an active pacemaker, or
  • death is expected in less than two weeks.
  • Caregivers will be excluded if they
  • cannot understand or speak English
  • have severe, uncorrected hearing loss
  • have self-reported uncontrolled atrial fibrillation
  • have a self-reported diagnosis of dementia
  • have a self-reported psychiatric disorder (bipolar disorder, schizophrenia)
  • are unwilling or unable to complete measures (both groups) or perform Reiki and self-Reiki (intervention cohort).

结局指标

主要结局

Establish successful enrollment of patient-caregiver dyads

时间窗: 10 days

Successful enrollment will be measured by the number of dyads enrolled versus those approached

Establish successful completion of patent-caregiver dyad data collection

时间窗: 10 days

Successful completion of data collection will be measured by the number of dyads who complete all data collection surveys from dyads enrolled

次要结局

  • Explore family caregiver feelings related to Reiki through the System usability Scale (modified)(Day 11)
  • Compare symptoms between patients in the intervention and usual care group(Days 0 and 11)
  • Compare symptoms between caregivers in the intervention and usual care group using the Rotterdam Symptom Checklist(Days 0 and 11)
  • Change in caregiver symptom profile as measured by the Rotterdam Symptom Checklist.(Days 0 and 11)
  • Change in heart rate variability measured using a heart rate monitor(Day 1 and 2)
  • Compare daily symptoms between caregivers in the intervention and usual care group(Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10)
  • Change in patient symptom profile as measured by the Rotterdam Symptom Checklist.(Days 0 and 11)
  • Change in caregiver symptom profile as measured by PROMIS-43.(Days 0 and 11)
  • Explore family caregiver feelings related to Reiki through the Reiki Experience Questionnaire (Reiki-EQ)(Day 11)
  • Compare daily symptoms between patients in the intervention and usual care group(Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10)
  • Compare symptoms between caregivers in the intervention and usual care group using the PROMIS-43 Symptom Profile(Days 0 and 11)
  • Change in caregiver daily symptoms as measured by the daily Symptom Severity Assessment.(Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10)
  • Change in daily patient symptoms as measured by the daily Symptom Severity Assessment.(Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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