Clinical trial NCT03685760: Reiki Intervention for Seriously Ill Elders Intensive Care Unit (RISE-ICU)
Official title: Reiki Intervention for Seriously Ill Elders Intensive Care Unit (RISE-ICU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Complementary Health Approach
Keywords: Mechanically Ventilated Older Adults
Reiki
Pain
Agitation
Delirium
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 39
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three Group Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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. The Reiki intervention involves a 30-minute treatment in which the participant is lightly touched for 3 minutes at each of 10 standardized Reiki hand positions (eyes, temples, crown, back of head, thymus/lungs, abdomen, scapula, mid back, lower back, feet). Sham Reiki. Three actors matched for age and sex with the Reiki therapists will administer sham Reiki. Sham interventionists may not be providers of any touch therapy or bodywork modalities (e.g. Reiki, Therapeutic Touch, Healing Touch, general massage) nor may they be providers of any type of complementary therapies (e.g. aromatherapy, guided imagery, hypnosis). The sham Reiki session consists of 30-minutes of direct contact using the same 10 standardized hand positions as the Reiki intervention. To minimize unconscious healing intentions, sham interventionists will occupy their minds with thoughts unrelated to the participant (e.g., counting backwards from 100 to 1). 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.

Eligibility criteria: Inclusion Criteria:

* \> 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Establish the timing of subject recruitment
timeFrame: Days 1, 2, or 3
measure: Establish level of protocol adherence by participants
timeFrame: Days 1-5
measure: Evaluate and refine the study protocol
timeFrame: Days 1-5
measure: Enrollment population
timeFrame: Days 1, 2, or 3
measure: Establish level of protocol adherence by Interventionists
timeFrame: Days 1-5
measure: Facilitators/Barriers to successful Reiki Intervention implementation
timeFrame: Days 1-5
Secondary outcomes:
measure: Pain assessed by numeric rating scale, (NRS)
timeFrame: Days 1-10
measure: Pain assessed by Critical-Care Pain Observation Tool (CPOT)
timeFrame: Days 1-10
measure: Level of Arousal
timeFrame: Days 1 - 10
measure: Delirium/ Coma free days
timeFrame: Days 1 - 10
measure: Anxiety level assessed with the Visual Analog Scale-Anxiety (VAS-A)
timeFrame: Days 1 - 10
measure: Other symptoms
timeFrame: Days 1 - 10
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Nursing
state: Ohio
Study officials:
affiliation: Ohio State University
name: Michele Balas, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: