Burnout, ProfessionalNCT05387746
Integrative Self-care Approaches for HCP Wellbeing
A study testing Caring Science, Mindful Practice and Reiki Training in people with Burnout, Professional, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this pilot study is to assess the impact of a hospital-based integrative self-care program (e.g., a. Reiki and b. Caring Science and Mindful Practice [CSMP] course) for interprofessional staff including nurses, physicians and/or medical residents, physical therapists, as well as other healthcare… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- Caring Science, Mindful Practice and Reiki Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 18 Aug 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Caring Science, Mindful Practice™ and Reiki: Integrative Self-care Approaches to Promote Interprofessional Healthcare Provider Wellbeing
The purpose of this pilot study is to assess the impact of a hospital-based integrative self-care program (e.g., a. Reiki and b. Caring Science and Mindful Practice [CSMP] course) for interprofessional staff including nurses, physicians and/or medical residents, physical therapists, as well as other healthcare providers on their wellbeing.
Read the 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.
- Conditions
- Burnout, Professional
- Being tested
- Caring Science, Mindful Practice and Reiki Training
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caring Science, Mindful Practice and Reiki TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Caring Science, Mindful Practice and Reiki Training | Other | Not described Receives: Behavioral: Caring Science, Mindful Practice and Reiki Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in perception of wellbeing
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.
Measured: baseline, 30 days post, and 60 days post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Sep 2022
- Primary completion18 Aug 2024
- Study completion18 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weil Foundation
- Responsible party
- Principal investigator, Linda Kim, Cedars-Sinai Medical Center
- Investigators
- Linda Kim, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387746
- Sponsor's protocol ID
- STUDY00002087
- Status last verified
- Aug 2024
- First submitted
- 19 May 2022
- Last updated
- 21 Aug 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring Science, Mindful Practice™ and Reiki: Integrative Self-care Approaches to Promote Interprofessional Healthcare Provider Wellbeing
- ClinicalTrials.gov ID
- NCT05387746
- Acronym / sponsor ID
- STUDY00002087
- Conditions
- Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Weil Foundation
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 18 Aug 2024 (actual)
- Study completion
- 18 Aug 2024 (actual)
- First posted
- 24 May 2022 (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 purpose of this pilot study is to assess the impact of a hospital-based integrative self-care program (e.g., a. Reiki and b. Caring Science and Mindful Practice [CSMP] course) for interprofessional staff including nurses, physicians and/or medical residents, physical therapists, as well as other healthcare providers on their wellbeing.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caring Science, Mindful Practice and Reiki Training | Other | Behavioral: Caring Science, Mindful Practice and Reiki Training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Healthcare provider must:
Key exclusion criteria (3 listed)
- Healthcare provider who do not meet all the inclusion criteria and/or reports:
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 |
|---|---|---|
| Caring Science, Mindful Practice and Reiki TrainingParticipants 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. | Behavioural | Caring Science, Mindful Practice and Reiki Training |
Primary outcome
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.
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 21 Aug 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.
Linda Kim principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caring Science, Mindful Practice and Reiki Training in people with Burnout, Professional, run by Cedars-Sinai Medical Center 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 6 inclusion and 3 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 21 Aug 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. 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?
Changes in perception of wellbeing (time frame: baseline, 30 days post, and 60 days post-training). 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 21 Aug 2024.