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
|Condition or disease||Intervention/treatment||Phase|
|Mechanical Ventilation Complication Complementary Health Approach||Other: Reiki therapy Other: Sham Reiki||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|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|
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.
- 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 .
- 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.
- 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.
- 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).
- 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.
- 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?"
- Other symptoms [ Time Frame: Days 1 - 10 ]As measured by Patient Symptom Survey
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
|Contact: Michele C Balas, PhDemail@example.com|
|Contact: Susan E Thrane, PhDfirstname.lastname@example.org|
|United States, Ohio|
|The Ohio State University College of Nursing||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Michele Balas, PhD RN 614-688-2050 email@example.com|
|Contact: Judith Tate, PhD, RN 614-292-4907 firstname.lastname@example.org|