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Trial record 65 of 73 for:    aromatherapy

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

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ClinicalTrials.gov Identifier: NCT03685760
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Ohio State University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Complementary Health Approach Other: Reiki therapy Other: Sham Reiki Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three Group Randomized Controlled Trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants and outcomes assessor are masked as well as all investigators except one co-investigator.
Primary Purpose: Supportive Care
Official Title: Reiki Intervention for Seriously Ill Elders Intensive Care Unit (RISE-ICU)
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : October 31, 2020

Arm Intervention/treatment
Experimental: Reiki
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.
Other: Reiki therapy
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 Comparator: Sham Reiki
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.
Other: Sham Reiki
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.

No Intervention: Usual Care
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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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 .


Secondary Outcome Measures :
  1. Pain assessed by numeric rating scale, (NRS) [ Time Frame: Days 1-10 ]
    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.

  2. Pain assessed by Critical-Care Pain Observation Tool (CPOT) [ Time Frame: Days 1-10 ]
    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.

  3. Level of Arousal [ Time Frame: Days 1 - 10 ]
    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).

  4. Delirium/ Coma free days [ Time Frame: Days 1 - 10 ]
    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.

  5. Anxiety level assessed with the Visual Analog Scale-Anxiety (VAS-A) [ Time Frame: Days 1 - 10 ]
    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?"

  6. Other symptoms [ Time Frame: Days 1 - 10 ]
    As measured by Patient Symptom Survey



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685760


Contacts
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Contact: Michele C Balas, PhD 614-688-2050 balas.17@osu.edu
Contact: Susan E Thrane, PhD 614-292-5684 thrane.2@osu.edu

Locations
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United States, Ohio
The Ohio State University College of Nursing Recruiting
Columbus, Ohio, United States, 43210
Contact: Michele Balas, PhD RN    614-688-2050    balas.17@osu.edu   
Contact: Judith Tate, PhD, RN    614-292-4907    tate.230@osu.edu   
Sponsors and Collaborators
Ohio State University

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Responsible Party: Ohio State University
ClinicalTrials.gov Identifier: NCT03685760     History of Changes
Other Study ID Numbers: 2017H0402
GRT00051029 ( Other Grant/Funding Number: American Association of Critical Care Nurses )
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ohio State University:
Mechanically Ventilated Older Adults
Reiki
Pain
Agitation
Delirium