Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03685760 |
Other study ID # |
2017H0402 |
Secondary ID |
GRT00051029 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 24, 2018 |
Est. completion date |
March 6, 2020 |
Study information
Verified date |
January 2022 |
Source |
Ohio State University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
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.
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.