Reiki Intervention for Seriously Ill Elders Intensive Care Unit (RISE-ICU)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 11/10/2018 |
| Start Date: | October 24, 2018 |
| End Date: | October 31, 2020 |
| Contact: | Michele C Balas, PhD |
| Email: | balas.17@osu.edu |
| Phone: | 614-688-2050 |
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 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 Tough, 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.
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 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 Tough, 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.
Inclusion Criteria:
- > 65 years old
- admitted to one of the participating MICUs
- intubated and on mechanical ventilation for acute respiratory failure
- expected to require mechanical ventilation for at least an additional 48 hours after
enrollment.
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
- transfer from another hospital or ICU on mechanical ventilation.
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