HospiceNCT04086017
Teaching Caregivers of Hospice Patients to Administer Reiki
A study testing Reiki therapy in people with Hospice and Pain, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Reiki therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Nursing
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the 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.
- Being tested
- Reiki therapy
- Keywords
- symptom management, Reiki therapy, self-care
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Reiki teaching | Experimental | 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. Receives: Other: Reiki therapy |
| Usual care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Establish successful enrollment of patient-caregiver dyads
Successful enrollment will be measured by the number of dyads enrolled versus those approached
Measured: 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
Measured: 10 days
Secondary outcomes (13)
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
Measured: 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."
Measured: 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.
Measured: 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
Measured: 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."
Measured: 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
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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."
Measured: 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.
Measured: Days 0 and 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 Oct 2020
- Primary completion4 May 2021
- Study completion31 Aug 2021
Why it stopped: Because of COVID-19 we moved to a virtual format but older patients and caregivers were not open to a virtual format.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospiceStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial: intervention and usual care
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- OhioHealth
- Responsible party
- Sponsor
- Investigators
- Susan E Thrane, PhD, RN, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086017
- Sponsor's protocol ID
- 2019B0544
- Status last verified
- Dec 2024
- First submitted
- 9 Sep 2019
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Caregivers of Hospice Patients to Administer Reiki for Symptom Management and Caregiver Support: A Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT04086017
- Acronym / sponsor ID
- 2019B0544
- Keywords
- symptom management, Reiki therapy, self-care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of COVID-19 we moved to a virtual format but older patients and caregivers were not open to a virtual format.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- OhioHealth
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial: intervention and usual care
| Arm | Type | Receives |
|---|---|---|
| Reiki teaching | Experimental | Other: Reiki therapyReiki 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. |
| Usual care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reiki therapyReiki 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. | Other | Reiki teaching |
Primary outcome
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
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
13 secondary outcomes
Change in heart rate variability measured using a heart rate monitor
Time frame: Day 1 and 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 through the Reiki Experience Questionnaire (Reiki-EQ)
Time frame: Day 11
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
Compare symptoms between patients in the intervention and usual care group
Time frame: Days 0 and 11
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
Compare symptoms between caregivers in the intervention and usual care group using the Rotterdam Symptom Checklist
Time frame: Days 0 and 11
Compare symptoms between caregivers in the intervention and usual care group using the PROMIS-43 Symptom Profile
Time frame: Days 0 and 11
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
Change in patient symptom profile as measured by the Rotterdam Symptom Checklist.
Time frame: Days 0 and 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
Change in caregiver symptom profile as measured by the Rotterdam Symptom Checklist.
Time frame: Days 0 and 11
Change in caregiver symptom profile as measured by PROMIS-43.
Time frame: Days 0 and 11
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Hospice
Not yet recruitingObservational study
IN-TALK: Co-producing a Hospice Intimacy Support Toolkit in England
Communication About Intimacy Needs in Hospice and Palliative Care
Not yet recruiting
Inpatient Hospice Transitions Checklist
Dementia
Not yet recruiting
Integrating Rhythmical Massage in Palliative Care
Palliative Care, Health Services, Palliative Care
RecruitingObservational study
Prehospital Care of End-of-Life Patients by the Strasbourg Mobile Emergency and Resuscitation Service: A Qualitative Study of Healthcare Professionals' Experiences and Use of a Comfort Care Booklet
End-of-life Care, Palliative Care
Recruiting
CommunityRx-Dementia + Peer Navigation (CRxDpeer)
Alzheimer s Disease, Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan E Thrane, PhD, RN principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki therapy in people with Hospice and Pain, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish successful enrollment of patient-caregiver dyads (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.