Clinical trial NCT04086017: Teaching Caregivers of Hospice Patients to Administer Reiki
Official title: Teaching Caregivers of Hospice Patients to Administer Reiki for Symptom Management and Caregiver Support: A Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hospice
Pain
Anxiety
Stress
Keywords: symptom management
Reiki therapy
self-care
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: OhioHealth
First posted: 2019-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial: intervention and usual care
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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).

Primary outcomes:
measure: Establish successful enrollment of patient-caregiver dyads
timeFrame: 10 days
measure: Establish successful completion of patent-caregiver dyad data collection
timeFrame: 10 days
Secondary outcomes:
measure: Change in heart rate variability measured using a heart rate monitor
timeFrame: Day 1 and 2
measure: Explore family caregiver feelings related to Reiki through the System usability Scale (modified)
timeFrame: Day 11
measure: Explore family caregiver feelings related to Reiki through the Reiki Experience Questionnaire (Reiki-EQ)
timeFrame: Day 11
measure: Compare daily symptoms between patients in the intervention and usual care group
timeFrame: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
measure: Compare symptoms between patients in the intervention and usual care group
timeFrame: Days 0 and 11
measure: Compare daily symptoms between caregivers in the intervention and usual care group
timeFrame: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
measure: Compare symptoms between caregivers in the intervention and usual care group using the Rotterdam Symptom Checklist
timeFrame: Days 0 and 11
measure: Compare symptoms between caregivers in the intervention and usual care group using the PROMIS-43 Symptom Profile
timeFrame: Days 0 and 11
measure: Change in daily patient symptoms as measured by the daily Symptom Severity Assessment.
timeFrame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
measure: Change in patient symptom profile as measured by the Rotterdam Symptom Checklist.
timeFrame: Days 0 and 11
measure: Change in caregiver daily symptoms as measured by the daily Symptom Severity Assessment.
timeFrame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
measure: Change in caregiver symptom profile as measured by the Rotterdam Symptom Checklist.
timeFrame: Days 0 and 11
measure: Change in caregiver symptom profile as measured by PROMIS-43.
timeFrame: Days 0 and 11
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Nursing
state: Ohio
Study officials:
affiliation: Ohio State University
name: Susan E Thrane, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: