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NCT03685760 · ClinicalTrials.gov registry record · NA
Reiki Intervention for Seriously Ill Elders Intensive Care Unit (RISE-ICU)
A NA study, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT03685760: Completed NA study, sponsored by Ohio State University.
NCT03685760 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03685760, a NA study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study 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 sy
Primary Outcome
Measured by the proportion of eligible patients enrolled on Days 1, 2, or 3 of mechanical ventilation initiation
Interventions
- OTHER Sham Reiki
- OTHER Reiki therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2020-03-06 |
| Phase | NA |
What the finished NCT03685760 record still lists
NCT03685760 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham Reiki is the first listed.
NCT03685760 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03685760 about?
NCT03685760 is a clinical study titled "Reiki Intervention for Seriously Ill Elders Intensive Care Unit (RISE-ICU)". 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 thr...
What is the current status of trial NCT03685760?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2018-10-24. Estimated completion is 2020-03-06.
What interventions are being tested in trial NCT03685760?
The interventions under investigation include: Sham Reiki (OTHER), Reiki therapy (OTHER).
Who is sponsoring clinical trial NCT03685760?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03685760's enrollment target sits among peer trials
39 1536th of 2000 higher than 463 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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