Wellbeing of Healthcare Providersin Frontline COVID-19 DepartmentsNCT05104827
Integrative Medicine Impact on Frontline COVID-19 Personnel Wellbeing
A study testing Complementary Integrative Medicine in people with Wellbeing of Healthcare Providersin Frontline COVID-19 Departments, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Treating COVID-19 hospitalized patients incurred heavy burden of physical and emotional stress. The present study is taking place at Carmel Medical Center in collaboration with the integrative oncology and the internal medicine teams with aim to improve the wellbeing of healthcare providers working in frontline… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wellbeing of Healthcare Providersin Frontline COVID-19 Departments
- What is being tested?
- Complementary Integrative Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Dec 2020to 1 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthcare providers and personnel working in frontline COVID-19 hospital departments.
Who cannot join
- Personnel not consenting to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eran Ben-Arye is the Study Primary Investigator
Treating COVID-19 hospitalized patients incurred heavy burden of physical and emotional stress. The present study is taking place at Carmel Medical Center in collaboration with the integrative oncology and the internal medicine teams with aim to improve the wellbeing of healthcare providers working in frontline COVID-19 departments. In this prospective preference study, Healthcare providers (HCPs) working inside COVID-19 departments are referred to integrative oncology-trained practitioners for assessment of their two leading concerns followed by 30-minute individually tailored treatment. The study assess, based on the Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire, the impact of personalized integrative oncology modalities on the physical and emotional concerns as well as Heart Rate Variability of participating HCPs in COVID-19 departments.
Read the detailed description
Background: Treating COVID-19 hospitalized patients incurred heavy burden of physical and emotional stress. The present study is taking place at Carmel Medical Center in collaboration with the integrative oncology and the internal medicine teams with aim to improve the wellbeing of healthcare providers working in frontline COVID-19 departments.
Purpose: To explore the impact of personalized integrative oncology modalities on the physical and emotional concerns as well as physiological parameters (e.g., Heart Rate Variability, HRV) of healthcare practitioners (HCPs) in COVID-19 department.
Methods: In this prospective preference study, HCPs working inside COVID-19 departments are referred to integrative oncology-trained practitioners for assessment of their two leading concerns followed by 30-minute individually tailored treatment, scheduled during the working shift and performed adjacent to the COVID department. Integrative treatment include one or more of the following modalities: acupuncture, manual (e.g., acupressure, anthroposophic medicine, reflexology), movement (QiGong, Feldenkrais and Paula methods), and mind-body therapies. The Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire is used for pre- and post-treatment quantitative and qualitative assessment. HCP's narratives analysis is purposed to identify concerns and impact of the integrative treatment program.
HRV is assessed during the integrative treatment. Three minutes intervals at start and after 20 minutes are used for pre- and post-treatment assessment. The primary outcome is RMSSD (root square of successive differences) indicating parasympathetic activity. Secondary outcomes are further parameters from the time domain analysis (SDNN, pNN50) and frequency domain analysis (LF/HF Ratio).
- Being tested
- Complementary Integrative Medicine
- Keywords
- Integrative medicine, Resilience, Covid-19, Quality of life
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complementary Integrative MedicineOther
Also called Acupuncture, acupressure, manual-movement, mind-body relaxation techniques
30-minute individually tailored integrative medicine care, including acupuncture, acupressure, reflexology, movement therapies like QiGong or Feldenkrais as well as Anthroposophic Medicine and mind-body treatments.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare providers | Experimental | Healthcare providers employed in COVID-19 departments are referred to integrative oncology-trained practitioners for an evaluation of their two main concerns, followed by a 30-minute individually tailored integrative care. Receives: Other: Complementary Integrative Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative quality of life assessment
Concerns analysis based on Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire on a scale ranging from 9 (no concern) to 6 (worst)
Measured: 48 hours
Qualitative quality of life assessment
Free-text narratives analysis using ATLAS.Ti software for systematic coding
Measured: 48 hours
Heart Rate Variability analysis
RMSSD parameter indicating parasympathetic activity
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start31 Dec 2020
- Primary completion31 Dec 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wellbeing of Healthcare Providersin Frontline COVID-19 DepartmentsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective non-controlled study
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eran Ben-Arye, Carmel Medical Center
- Investigators
- Eran Ben-Arye, MD, Principal investigator, Medical director, Integrative Oncology Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104827
- Sponsor's protocol ID
- CMC-20-0202
- Status last verified
- Aug 2024
- First submitted
- 1 Nov 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vagedes J, Kassem S, Gressel O, Samuels N, Eden A, Ben-Arye E. Parasympathetic Versus Sympathetic Changes in Heart Rate Variability After a Multimodal Integrative Medicine Intervention for Frontline COVID-19 Personnel. Psychosom Med. 2023 Jan 1;85(1):53-60. doi: 10.1097/PSY.0000000000001153. Epub 2022 Nov 9.
PubMed 36346679
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
- Eran Ben-Arye is the Study Primary Investigator
- ClinicalTrials.gov ID
- NCT05104827
- Acronym / sponsor ID
- CMC-20-0202
- Keywords
- Integrative medicine, Resilience, Covid-19, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 3 Nov 2021 (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.
Treating COVID-19 hospitalized patients incurred heavy burden of physical and emotional stress. The present study is taking place at Carmel Medical Center in collaboration with the integrative oncology and the internal medicine teams with aim to improve the wellbeing of healthcare providers working in frontline COVID-19 departments. In this prospective preference study, Healthcare providers (HCPs) working inside COVID-19 departments are referred to integrative oncology-trained practitioners for assessment of their two leading concerns followed by 30-minute individually tailored treatment. The study assess, based on the Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire, the impact of personalized integrative oncology modalities on the physical and emotional concerns as well as Heart Rate Variability of participating HCPs in COVID-19 departments.
Detailed description
Background: Treating COVID-19 hospitalized patients incurred heavy burden of physical and emotional stress. The present study is taking place at Carmel Medical Center in collaboration with the integrative oncology and the internal medicine teams with aim to improve the wellbeing of healthcare providers working in frontline COVID-19 departments.
Purpose: To explore the impact of personalized integrative oncology modalities on the physical and emotional concerns as well as physiological parameters (e.g., Heart Rate Variability, HRV) of healthcare practitioners (HCPs) in COVID-19 department.
Methods: In this prospective preference study, HCPs working inside COVID-19 departments are referred to integrative oncology-trained practitioners for assessment of their two leading concerns followed by 30-minute individually tailored treatment, scheduled during the working shift and performed adjacent to the COVID department. Integrative treatment include one or more of the following modalities: acupuncture, manual (e.g., acupressure, anthroposophic medicine, reflexology), movement (QiGong, Feldenkrais and Paula methods), and mind-body therapies. The Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire is used for pre- and post-treatment quantitative and qualitative assessment. HCP's narratives analysis is purposed to identify concerns and impact of the integrative treatment program.
HRV is assessed during the integrative treatment. Three minutes intervals at start and after 20 minutes are used for pre- and post-treatment assessment. The primary outcome is RMSSD (root square of successive differences) indicating parasympathetic activity. Secondary outcomes are further parameters from the time domain analysis (SDNN, pNN50) and frequency domain analysis (LF/HF Ratio).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective non-controlled study
| Arm | Type | Receives |
|---|---|---|
| Healthcare providers | Experimental | Other: Complementary Integrative MedicineHealthcare providers employed in COVID-19 departments are referred to integrative oncology-trained practitioners for an evaluation of their two main concerns, followed by a 30-minute individually tailored integrative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare providers and personnel working in frontline COVID-19 hospital departments.
Key exclusion criteria (1 listed)
- Personnel not consenting to participate
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 |
|---|---|---|
| Complementary Integrative MedicineAlso: Acupuncture, acupressure, manual-movement, mind-body relaxation techniques30-minute individually tailored integrative medicine care, including acupuncture, acupressure, reflexology, movement therapies like QiGong or Feldenkrais as well as Anthroposophic Medicine and mind-body treatments. | Other | Healthcare providers |
Primary outcome
Quantitative quality of life assessment
Time frame: 48 hours
Concerns analysis based on Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire on a scale ranging from 9 (no concern) to 6 (worst)
Qualitative quality of life assessment
Time frame: 48 hours
Free-text narratives analysis using ATLAS.Ti software for systematic coding
Heart Rate Variability analysis
Time frame: 30 minutes
RMSSD parameter indicating parasympathetic activity
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.
- Derived from this study: PubMed 36346679Vagedes J, Kassem S, Gressel O, Samuels N, Eden A, Ben-Arye E. Parasympathetic Versus Sympathetic Changes in Heart Rate Variability After a Multimodal Integrative Medicine Intervention for Frontline COVID-19 Personnel. Psychosom Med. 2023 Jan 1;85(1):53-60. doi: 10.1097/PSY.0000000000001153. Epub 2022 Nov 9.
- Individual participant dataSharing planned: No
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.
Eran Ben-Arye, MD principal investigator
Medical director, Integrative Oncology Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complementary Integrative Medicine in people with Wellbeing of Healthcare Providersin Frontline COVID-19 Departments, run by Carmel Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 Israel. 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?
Quantitative quality of life assessment (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05104827, which also lists 1 linked publication.
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.