Mechanical Ventilation ComplicationRISE-ICUNCT03685760
Reiki Intervention for Seriously Ill Elders Intensive Care Unit (RISE-ICU)
A study testing Reiki therapy in people with Mechanical Ventilation Complication and Complementary Health Approach, run by Ohio State University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Complementary Health Approach
- What is being tested?
- Reiki therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2018to 6 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Nursing
Columbus, Ohio, 43210
About this study
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.
Read the 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.
- Being tested
- Reiki therapy, Sham Reiki
- Keywords
- Mechanically Ventilated Older Adults, Reiki, Pain, Agitation, Delirium
- Medical subject headings
- Pain, Psychomotor Agitation, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki therapyOther
Reiki, a complementary health approach where trained practitioners place their hands lightly on or just above a person, in discrete positions, with the goal of facilitating the person's own healing response. Reiki therapists will administer the Reiki intervention (i.e., a 30-minute treatment in which the subject is lightly touched for 3 minutes at each of 10 standardized Reiki hand positions).
Sham ReikiOther
Sham (pretend) Reiki therapists will administer the sham Reiki intervention (i.e., a 30-minute treatment in which the subject is lightly touched for 3 minutes at each of 10 standardized Reiki hand positions). Sham providers do not have Reiki training.
| Study group | Role | What they receive |
|---|---|---|
| Reiki | Experimental | Reiki will be administered for 5 consecutive days even if the subject is transferred to the floor from the ICU. Thirty minutes before and after the daily Reiki, session, the bedside nurse will obtain a set of baseline vital signs (heart rate, respiratory rate, blood pressure; non-invasively) for safety monitoring data. Receives: Other: Reiki therapy |
| Sham Reiki | Sham comparator | Sham Reiki will be administered for 5 consecutive days even if the subject is transferred to the floor from the ICU. Thirty minutes before and after the daily sham Reiki, session, the bedside nurse will obtain a set of baseline vital signs (heart rate, respiratory rate, blood pressure; non-invasively) for safety monitoring data. Receives: Other: Sham Reiki |
| Usual Care | No intervention | Twice per day, 30 minutes apart, the bedside nurse will obtain a set of baseline vital signs (heart rate, respiratory rate, blood pressure; non-invasively) for safety monitoring data. Usual care will also involve a 5-day period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the timing of subject recruitment
Measured by the proportion of eligible patients enrolled on Days 1, 2, or 3 of mechanical ventilation initiation
Measured: Days 1, 2, or 3
Establish level of protocol adherence by participants
Measured by the number of days on protocol that subjects complete assigned intervention
Measured: Days 1-5
Evaluate and refine the study protocol
Number of participants that complete the daily in-person pain, anxiety, and delirium assessments
Measured: Days 1-5
Enrollment population
Measured by the number and proportion of patients versus legally authorized representatives (LARs) who consent to study enrollment.
Measured: Days 1, 2, or 3
Establish level of protocol adherence by Interventionists
The ability of Reiki and sham Reiki interventionists to adhere to study protocol.
Measured: Days 1-5
Facilitators/Barriers to successful Reiki Intervention implementation
Measure subject and LAR perception of the enrollment process, interventions, and symptom management effectiveness over the 5 day intervention period as assessed by the questionnaires completed .
Measured: Days 1-5
Secondary outcomes (6)
Pain assessed by numeric rating scale, (NRS)
Incidence, severity, and duration of pain as measured using a 0-10 visually enlarged horizontal pain numeric rating scale (NRS) in participants that can self report.
Measured: Days 1-10
Pain assessed by Critical-Care Pain Observation Tool (CPOT)
Incidence, severity, and duration of pain as measured by the Critical-Care Pain Observation Tool (CPOT) for participants that are unable to self report. The CPOT has four behavioral categories: facial expression; body movements; muscle tension; and compliance with the ventilator for intubated subjects or vocalization for extubated subjects. Items in each section are scored 0 to 2, with a possible total score of 0 to 8.
Measured: Days 1-10
Level of Arousal
As measured by Richmond Agitation and Sedation Scale (RASS) which is a 10-point scale, with four levels of anxiety or agitation ranging from +1 (restless) to +4 (combative), one level representing an alert and calm state (0), and five levels of sedation ranging from -5 (unarousable) to -1 (drowsy).
Measured: Days 1 - 10
Delirium/ Coma free days
As measured by Confusion Assessment Method ICU (CAM-ICU) which includes four features of delirium: (1) acute onset or fluctuating course; (2) inattention; (3) disorganized thinking.
Measured: Days 1 - 10
Anxiety level assessed with the Visual Analog Scale-Anxiety (VAS-A)
Anxiety will be measured with the 100-mm Visual Analog Scale-Anxiety. The VAS-A will be presented to participants with a vertical orientation; the bottom of the scale anchored by the statement "not anxious at all" and the top anchored by "most anxious ever." Subjects will indicate their current level of anxiety in response to the question "How anxious are you feeling today?"
Measured: Days 1 - 10
Other symptoms
As measured by Patient Symptom Survey
Measured: Days 1 - 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start24 Oct 2018
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three Group Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Balas, PhD, RN, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685760
- Sponsor's protocol ID
- 2017H0402
- Other IDs
- GRT00051029
- Acronym
- RISE-ICU
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reiki Intervention for Seriously Ill Elders Intensive Care Unit (RISE-ICU)
- ClinicalTrials.gov ID
- NCT03685760
- Acronym / sponsor ID
- RISE-ICU / 2017H0402
- Keywords
- Mechanically Ventilated Older Adults, Reiki, Pain, Agitation, Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three Group Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Reiki | Experimental | Other: Reiki therapyReiki will be administered for 5 consecutive days even if the subject is transferred to the floor from the ICU. Thirty minutes before and after the daily Reiki, session, the bedside nurse will obtain a set of baseline vital signs (heart rate, respiratory rate, blood pressure; non-invasively) for safety monitoring data. |
| Sham Reiki | Sham comparator | Other: Sham ReikiSham Reiki will be administered for 5 consecutive days even if the subject is transferred to the floor from the ICU. Thirty minutes before and after the daily sham Reiki, session, the bedside nurse will obtain a set of baseline vital signs (heart rate, respiratory rate, blood pressure; non-invasively) for safety monitoring data. |
| Usual Care | No intervention | –Twice per day, 30 minutes apart, the bedside nurse will obtain a set of baseline vital signs (heart rate, respiratory rate, blood pressure; non-invasively) for safety monitoring data. Usual care will also involve a 5-day period. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reiki therapyReiki, a complementary health approach where trained practitioners place their hands lightly on or just above a person, in discrete positions, with the goal of facilitating the person's own healing response. Reiki therapists will administer the Reiki intervention (i.e., a 30-minute treatment in which the subject is lightly touched for 3 minutes at each of 10 standardized Reiki hand positions). | Other | Reiki |
| Sham ReikiSham (pretend) Reiki therapists will administer the sham Reiki intervention (i.e., a 30-minute treatment in which the subject is lightly touched for 3 minutes at each of 10 standardized Reiki hand positions). Sham providers do not have Reiki training. | Other | Sham Reiki |
Primary outcome
Establish the timing of subject recruitment
Time frame: Days 1, 2, or 3
Measured by the proportion of eligible patients enrolled on Days 1, 2, or 3 of mechanical ventilation initiation
Establish level of protocol adherence by participants
Time frame: Days 1-5
Measured by the number of days on protocol that subjects complete assigned intervention
Evaluate and refine the study protocol
Time frame: Days 1-5
Number of participants that complete the daily in-person pain, anxiety, and delirium assessments
Enrollment population
Time frame: Days 1, 2, or 3
Measured by the number and proportion of patients versus legally authorized representatives (LARs) who consent to study enrollment.
Establish level of protocol adherence by Interventionists
Time frame: Days 1-5
The ability of Reiki and sham Reiki interventionists to adhere to study protocol.
Facilitators/Barriers to successful Reiki Intervention implementation
Time frame: Days 1-5
Measure subject and LAR perception of the enrollment process, interventions, and symptom management effectiveness over the 5 day intervention period as assessed by the questionnaires completed .
6 secondary outcomes
Pain assessed by numeric rating scale, (NRS)
Time frame: Days 1-10
Pain assessed by Critical-Care Pain Observation Tool (CPOT)
Time frame: Days 1-10
Level of Arousal
Time frame: Days 1 - 10
Delirium/ Coma free days
Time frame: Days 1 - 10
Anxiety level assessed with the Visual Analog Scale-Anxiety (VAS-A)
Time frame: Days 1 - 10
Other symptoms
Time frame: Days 1 - 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Balas, PhD, RN principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki therapy in people with Mechanical Ventilation Complication and Complementary Health Approach, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the timing of subject recruitment (time frame: Days 1, 2, or 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.