Teaching Caregivers of Hospice Patients to Administer Reiki

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain; Stress; Anxiety; Hospice
• Intervention / Treatment: Other: Reiki therapy

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reiki teaching; Reiki Master will perform the teaching and attunement process for Level 1 Reiki and teach the caregiver(s) how to complete a simple 10-minute Reiki session with the patient and a 10-minute self-Reiki session for the caregiver(s). The Reiki Master will explain that Reiki sessions can be given whenever the patient and caregiver feel it is appropriate, but sessions should be at minimum twice per 24-hour period for at least 10 minutes with at least two hours between sessions. Reiki sessions may be more frequent than twice per day and/or longer than 10 minutes. Self-Reiki sessions should be performed daily for at least 10 minutes but maybe more frequent and/or longer in length. Each family caregiver will receive a copy of the book. The patient and caregiver will wear a Holter monitor continuously for 48 hours beginning when the caregiver(s) are trained in Reiki to measure HRV, a valid measure for stress.	Other: Reiki therapy; Reiki is a complementary health approach where trained providers place their hands lightly on or just above a person, in discrete positions, with the goal of facilitating the person's own healing response. A Reiki practitioner will perform the initial teaching and instruct the caregivers how to perform a simple 10-minute Reiki and self-Reiki session.
No Intervention: Usual care; Patients and caregivers will complete all measures expected of the intervention cohort including daily symptom checklist for 10 days. The patient and caregiver will wear a Holter monitor for the first 48 hours of study participation to measure heart rate variability (HRV), a valid measure for stress. The patient and/or caregiver may opt out of the Holter monitor if requested and still participate in the rest of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish successful enrollment of patient-caregiver dyads	Successful enrollment will be measured by the number of dyads enrolled versus those approached	10 days
Establish successful completion of patent-caregiver dyad data collection	Successful completion of data collection will be measured by the number of dyads who complete all data collection surveys from dyads enrolled	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate variability measured using a heart rate monitor	Explore heart rate variability as a measure of stress using a heart rate monitor in end-of-life patients and their caregivers	Day 1 and 2
Explore family caregiver feelings related to Reiki through the System usability Scale (modified)	Explore family caregiver feelings related to Reiki by having caregivers complete the System Usability Scale (modified) at the end of the 10 day intervention period. The System Usability Scale is a 13 item survey that measures whether respondents thought that learning Reiki went well, was understandable, and if they were confident using Reiki. Each item is answered by circling an answer on a Likert scale from "strongly disagree" to "strongly agree."	Day 11
Explore family caregiver feelings related to Reiki through the Reiki Experience Questionnaire (Reiki-EQ)	Explore family caregiver feelings related to Reiki by having caregivers complete the Reiki-EQ at the end of the 10 day intervention period. This questionnaire is a combination of Likert responses as well as optional an area for participants to write additional information if they would like. This questionnaire assesses what the participants thought about learning and providing Reiki.	Day 11
Compare daily symptoms between patients in the intervention and usual care group	Examine and describe changes in 6 symptoms daily using the Daily Symptom Severity Assessment (SSA). The SSA measures 6 symptoms (pain, anxiety, shortness of breath, nausea, sleep, and sense of inner peace/happiness) using a visual analog scale	Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
Compare symptoms between patients in the intervention and usual care group	Examine and describe symptom profiles, present illness, and co-morbidities of patients using the Rotterdam Symptom Checklist. The Rotterdam Symptom Checklist is a list of 30 common symptoms. Following each symptom is a Likert scale with four choices ranging from "not at all" to "very much."	Days 0 and 11
Compare daily symptoms between caregivers in the intervention and usual care group	Examine and describe changes in 6 symptoms daily using the Daily Symptom Severity Assessment (SSA). The SSA measures 6 symptoms (pain, anxiety, shortness of breath, nausea, sleep, and sense of inner peace/happiness) using a visual analog scale	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 Rotterdam Symptom Checklist	Examine and describe symptom profiles, present illness, and co-morbidities of caregivers using the Rotterdam Symptom Checklist. The Rotterdam Symptom Checklist is a list of 30 common symptoms. Following each symptom is a Likert scale with four choices ranging from "not at all" to "very much."	Days 0 and 11
Compare symptoms between caregivers in the intervention and usual care group using the PROMIS-43 Symptom Profile	Examine and describe symptom profiles of family caregivers using the Patient Reported Outcomes Measurement Information System (PROMIS-43). The PROMIS-43 asks 6 questions within each of 7 symptom domains (physical function, anxiety, depression, fatigue, sleep disturbance, social activities, and pain interference) as well as a pain intensity score from 0 to 10. Questions in symptom domains are scored on a 5 level Likert score from "not at all" or "never" to "very much" or "always." Scores on this measure are totaled with a lower score indicating a better ability to function.	Days 0 and 11
Change in daily patient symptoms as measured by the daily Symptom Severity Assessment.	Explore the patient symptoms within the intervention and usual care groups as measured by the daily Symptom Severity Assessment (SSA) over the study period. The SSA measures 6 symptoms (pain, anxiety, shortness of breath, nausea, sleep, and sense of inner peace/happiness) using a visual analog scale. Changes will be assessed within the intervention and usual care groups.	Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
Change in patient symptom profile as measured by the Rotterdam Symptom Checklist.	Explore the patient symptoms within the intervention and usual care groups as measured by the Rotterdam Symptom Checklist. Examine and describe symptom profiles, present illness, and co-morbidities of patients using the Rotterdam Symptom Checklist. The Rotterdam Symptom Checklist is a list of 30 common symptoms. Following each symptom is a Likert scale with four choices ranging from "not at all" to "very much."	Days 0 and 11
Change in caregiver daily symptoms as measured by the daily Symptom Severity Assessment.	Explore the caregiver symptoms within the intervention and usual care groups as measured by the daily Symptom Severity Assessment (SSA) over the study period. The SSA measures 6 symptoms (pain, anxiety, shortness of breath, nausea, sleep, and sense of inner peace/happiness) using a visual analog scale. Changes will be assessed within the intervention and usual care groups.	Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
Change in caregiver symptom profile as measured by the Rotterdam Symptom Checklist.	Explore the caregiver symptoms within the intervention and usual care groups as measured by the Rotterdam Symptom Checklist. Examine and describe symptom profiles, present illness, and co-morbidities of patients using the Rotterdam Symptom Checklist. The Rotterdam Symptom Checklist is a list of 30 common symptoms. Following each symptom is a Likert scale with four choices ranging from "not at all" to "very much."	Days 0 and 11
Change in caregiver symptom profile as measured by PROMIS-43.	Explore the caregiver symptoms within the intervention and usual care groups as measured by Patient Reported Outcome Measurement Information System (PROMIS) symptom questionnaire over the study period. The PROMIS-43 asks 6 questions within each of 7 symptom domains (physical function, anxiety, depression, fatigue, sleep disturbance, social activities, and pain interference) as well as a pain intensity score from 0 to 10. Questions in symptom domains are scored on a 5 level Likert score from "not at all" or "never" to "very much" or "always." Scores on this measure are totaled with a lower score indicating a better ability to function.	Days 0 and 11

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: OhioHealth
• Investigators: Principal Investigator: Susan E Thrane, PhD, RN, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): May 4, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: symptom management; self-care; Reiki therapy
• Other Study ID Numbers: 2019B0544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No