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

Mechanical Ventilation Complication Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Complementary Health Approach
• Mechanical Ventilation Complication

• NCT number: NCT03685760
• Study type: Interventional
• Source: Ohio State University
• Status: Completed
• Phase: N/A
• Start date: October 24, 2018
• Completion date: March 6, 2020