Teaching Caregivers of Hospice Patients to Administer Reiki

NCT04086017 | Withdrawn DMC

• 1 other identifier: 2019B0544
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospice; Pain; Anxiety; Stress

Keywords

symptom management; Reiki therapy; self-care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Change in heart rate variability measured using a heart rate monitor

  Day 1 and 2

• Explore family caregiver feelings related to Reiki through the System usability Scale (modified)

  Day 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 patients in the intervention and usual care group

  Days 0 and 11

Study Arms (2)

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.

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.

Interventions

Reiki therapy OTHER

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.

Reiki teaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ohio State University: lead
• OhioHealth: collaborator

Study Sites (1)

The Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Susan E Thrane, PhD, RN

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial: intervention and usual care

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: October 1, 2020
• Primary Completion: May 4, 2021
• Study Completion: August 31, 2021
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)