Reiki Intervention for Seriously Ill Elders Intensive Care Unit (RISE-ICU)

NCT03685760 | Completed

• 2 other identifiers: 2017H0402GRT00051029
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this proposal is to demonstrate the feasibility of conducting a future large-scale, randomized controlled trial (RCT) to test whether Reiki is superior to sham Reiki and usual care when delivered to critically ill older adults who require mechanical ventilation (MV). Our three-arm, pilot RCT will include 45 subjects and their LARs (45) recruited from the Ohio State University Wexner Medical Center (OSU-WMC) intensive care units (ICUs) who are randomly allocated 1:1:1 to: 1) Reiki, 2) sham Reiki, or 3) usual care for 5 days or until the subject is discharged from the hospital or expires. The Investigators will perform interviews with the subjects' LARs upon study enrollment to determine the subjects preadmission physical, functional, and cognitive health status. Each subject will be assessed for pain, anxiety, and agitation and have their vital signs taken daily for 5 days using valid and reliable tools. Medical records will be used to record demographic and clinical characteristics. The Investigators will survey each subject and their LAR regarding their experiences with the Reiki, sham Reiki or usual care sessions. Reiki and sham Reiki will be administered for 5 consecutive days even if the subject is transferred to the floor from the ICU. Usual care will also involve a 5-day period. Study Arms. Reiki. Three professional Reiki therapists trained at Level 2 (intermediate) and with a minimum of 2 years of Reiki practice will administer the Reiki intervention. Sham Reiki. Three actors will administer sham Reiki. Usual Care. Subjects assigned to usual care will not receive Reiki or sham Reiki. The usual care group will undergo the same in-person symptom assessments and electronic health record (EHR) reviews as the Reiki and sham Reiki groups. Reiki therapy is not part of usual care in the participating ICUs. The knowledge gained from this study will contribute to a better understanding of how/if a nonpharmacologic intervention can reduce the symptoms experienced by critically ill older adults.

Conditions

Mechanical Ventilation Complication; Complementary Health Approach

Keywords

Mechanically Ventilated Older Adults; Reiki; Pain; Agitation; Delirium

Outcome Measures

Primary Outcomes (6)

• Establish the timing of subject recruitment

  Measured by the proportion of eligible patients enrolled on Days 1, 2, or 3 of mechanical ventilation initiation

  Days 1, 2, or 3

• Establish level of protocol adherence by participants

  Measured by the number of days on protocol that subjects complete assigned intervention

  Days 1-5

• Evaluate and refine the study protocol

  Number of participants that complete the daily in-person pain, anxiety, and delirium assessments

  Days 1-5

• Enrollment population

  Measured by the number and proportion of patients versus legally authorized representatives (LARs) who consent to study enrollment.

  Days 1, 2, or 3

• Establish level of protocol adherence by Interventionists

  The ability of Reiki and sham Reiki interventionists to adhere to study protocol.

  Days 1-5

• Facilitators/Barriers to successful Reiki Intervention implementation

  Measure subject and LAR perception of the enrollment process, interventions, and symptom management effectiveness over the 5 day intervention period as assessed by the questionnaires completed .

  Days 1-5

Secondary Outcomes (6)

• Pain assessed by numeric rating scale, (NRS)

  Days 1-10

• Pain assessed by Critical-Care Pain Observation Tool (CPOT)

  Days 1-10

• Level of Arousal

  Days 1 - 10

• Delirium/ Coma free days

  Days 1 - 10

• Anxiety level assessed with the Visual Analog Scale-Anxiety (VAS-A)

  Days 1 - 10

Study Arms (3)

Reiki

EXPERIMENTAL

Reiki will be administered for 5 consecutive days even if the subject is transferred to the floor from the ICU. Thirty minutes before and after the daily Reiki, session, the bedside nurse will obtain a set of baseline vital signs (heart rate, respiratory rate, blood pressure; non-invasively) for safety monitoring data.

Other: Reiki therapy

Sham Reiki

SHAM COMPARATOR

Sham Reiki will be administered for 5 consecutive days even if the subject is transferred to the floor from the ICU. Thirty minutes before and after the daily sham Reiki, session, the bedside nurse will obtain a set of baseline vital signs (heart rate, respiratory rate, blood pressure; non-invasively) for safety monitoring data.

Other: Sham Reiki

Usual Care

NO INTERVENTION

Twice per day, 30 minutes apart, the bedside nurse will obtain a set of baseline vital signs (heart rate, respiratory rate, blood pressure; non-invasively) for safety monitoring data. Usual care will also involve a 5-day period.

Interventions

Reiki therapy OTHER

Reiki, a complementary health approach where trained practitioners place their hands lightly on or just above a person, in discrete positions, with the goal of facilitating the person's own healing response. Reiki therapists will administer the Reiki intervention (i.e., a 30-minute treatment in which the subject is lightly touched for 3 minutes at each of 10 standardized Reiki hand positions).

Reiki

Sham Reiki OTHER

Sham (pretend) Reiki therapists will administer the sham Reiki intervention (i.e., a 30-minute treatment in which the subject is lightly touched for 3 minutes at each of 10 standardized Reiki hand positions). Sham providers do not have Reiki training.

Sham Reiki

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 55 years old
• admitted to one of the participating medical intensive care units (MICUs)
• intubated and on mechanical ventilation for acute respiratory failure
• expected to require mechanical ventilation for at least an additional 48 hours after enrollment.
• all critically ill patients age 55 and older with acute respiratory failure, on mechanical ventilation (invasive and noninvasive) or high flow oxygen therapy

You may not qualify if:

• coma due to structural brain diseases (e.g., stroke, intracranial hemorrhage, anoxic brain injury)
• expected death within 24 hours of study enrollment or lack of commitment to aggressive treatment by family/medical team
• inability to reach LAR to provide consent within 72 hours of ICU admission
• legal blindness or deafness because these patients cannot be assessed using the proposed study instruments
• airborne isolation precautions to minimize interventionists exposure and need for N95 respirators

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pain; Psychomotor Agitation; Delirium

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Confusion; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Michele Balas, PhD, RN

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessor are masked as well as all investigators except one co-investigator.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three Group Randomized Controlled Trial

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 26, 2018
• Study Start: October 24, 2018
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)