- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05387746
Integrative Self-care Approaches for HCP Wellbeing
Caring Science, Mindful Practice™ and Reiki: Integrative Self-care Approaches to Promote Interprofessional Healthcare Provider Wellbeing
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary research procedures are:
- Participants will complete an online pre-training survey via REDCap, including a demographic questionnaire, and questions related to Physical Function, Depression, Anxiety, Fatigue, Sleep Disturbance, Social Roles/Activities, Resilience, Burnout, COVID-19 Experience, Caring Science, and Reiki Knowledge and Application.
- Participants will participate in the 4-week (virtual) CSMP and (in-person) Reiki Training course.
- Participants will complete the online post-training survey with the same questions included in the pre-training survey.
- Data analysis will be conducted by the research team using descriptive statistics, bivariate analysis, and multivariate linear/logistic regression analysis to assess for relationships between the Reiki and CSMP training and HCP wellbeing.
The research team will enroll up to 20 participants comprising of interprofessional staff including nurses, physicians and/or medical residents, physical therapists, as well as other healthcare providers.
All parts of the protocol will be conducted at CSMC.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Healthcare provider must:
- Be 18 years or older
- Be full-time employee of a CSMC hospital/clinic
- MDs/DOs must have admitting privileges to a hospital and/or have private practice/ or be a current medical resident enrolled in a Cedars Sinai Medical Residency Program
- Provide direct patient care in hospital and/or clinic
- Consent to participating in the study
Exclusion Criteria:
Healthcare provider who do not meet all the inclusion criteria and/or reports:
- They do not provide direct patient care
- Do not consent to participating in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Caring Science, Mindful Practice and Reiki Training
|
Participants will complete a) 4 week internet-based course on Caring Science Mindful Practice and b) 12 hour Reiki training.
The participants will also complete online post-training survey with the same questions included in pre-training survey.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in perception of wellbeing
Time Frame: baseline, 30 days post, and 60 days post-training
|
PROMIS® is a publicly available, highly reliable, precise measure of patient-reported health status for physical, mental, and social well-being.
Maslach Burnout Inventory covers 3 areas: Emotional Exhaustion, Depersonalization, and low sense of Personal Accomplishment.
The investigator chose two items from the MBI as a previous study has shown that relative to the full MBI, single-item measures of emotional exhaustion and depersonalization exhibit strong and consistent associations with key outcomes in various HCWs.
Connor-Davidson Resilience Scale is a brief, two-item self-rated measure of resilience, which has shown to have internal consistency, test-retest reliability, convergent validity, and divergent validity as well as significant correlation with the full scale.
The investigator will also collect information including demographics, COVID-19 experiences, and knowledge/application of CSMP and Reiki using generic questionnaires that have not been validated.
|
baseline, 30 days post, and 60 days post-training
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Linda Kim, Cedars-Sinai Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00002087
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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