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Teaching Caregivers of Hospice Patients to Administer Reiki

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04086017
Recruitment Status : Not yet recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
OhioHealth
Information provided by (Responsible Party):
Susan Thrane, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Hospice Pain Anxiety Stress Other: Reiki therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial: intervention and usual care
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Teaching Caregivers of Hospice Patients to Administer Reiki for Symptom Management and Caregiver Support: A Feasibility Pilot Study
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Establish successful enrollment of patient-caregiver dyads [ Time Frame: 10 days ]
    Successful enrollment will be measured by the number of dyads enrolled versus those approached

  2. Establish successful completion of patent-caregiver dyad data collection [ Time Frame: 10 days ]
    Successful completion of data collection will be measured by the number of dyads who complete all data collection surveys from dyads enrolled


Secondary Outcome Measures :
  1. Change in heart rate variability measured using a heart rate monitor [ Time Frame: Day 1 and 2 ]
    Explore heart rate variability as a measure of stress using a heart rate monitor in end-of-life patients and their caregivers

  2. Explore family caregiver feelings related to Reiki through the System usability Scale (modified) [ Time Frame: Day 11 ]
    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."

  3. Explore family caregiver feelings related to Reiki through the Reiki Experience Questionnaire (Reiki-EQ) [ Time Frame: Day 11 ]
    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.

  4. Compare daily symptoms between patients in the intervention and usual care group [ Time Frame: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 ]
    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

  5. Compare symptoms between patients in the intervention and usual care group [ Time Frame: Days 0 and 11 ]
    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."

  6. Compare daily symptoms between caregivers in the intervention and usual care group [ Time Frame: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 ]
    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

  7. Compare symptoms between caregivers in the intervention and usual care group using the Rotterdam Symptom Checklist [ Time Frame: Days 0 and 11 ]
    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."

  8. Compare symptoms between caregivers in the intervention and usual care group using the PROMIS-43 Symptom Profile [ Time Frame: Days 0 and 11 ]
    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.

  9. Change in daily patient symptoms as measured by the daily Symptom Severity Assessment. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 ]
    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.

  10. Change in patient symptom profile as measured by the Rotterdam Symptom Checklist. [ Time Frame: Days 0 and 11 ]
    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."

  11. Change in caregiver daily symptoms as measured by the daily Symptom Severity Assessment. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 ]
    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.

  12. Change in caregiver symptom profile as measured by the Rotterdam Symptom Checklist. [ Time Frame: Days 0 and 11 ]
    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."

  13. Change in caregiver symptom profile as measured by PROMIS-43. [ Time Frame: Days 0 and 11 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086017


Contacts
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Contact: Susan E Thrane, PhD, RN 614-292-5684 thrane.2@osu.edu
Contact: Charles von Gunten, MD, PhD 614-533-6299 Charles.vonGunten@ohiohealth.com

Locations
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United States, Ohio
The Ohio State University College of Nursing
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
OhioHealth
Investigators
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Principal Investigator: Susan E Thrane, PhD, RN Ohio State University

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Responsible Party: Susan Thrane, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT04086017     History of Changes
Other Study ID Numbers: 2019X0052
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susan Thrane, Ohio State University:
symptom management
Reiki therapy
self-care