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Integrative Medicine Impact on Frontline COVID-19 Personnel Wellbeing

Primary Purpose

Wellbeing of Healthcare Providersin Frontline COVID-19 Departments

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Complementary Integrative Medicine
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Wellbeing of Healthcare Providersin Frontline COVID-19 Departments focused on measuring Integrative medicine, Resilience, Covid-19, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

* Healthcare providers and personnel working in frontline COVID-19 hospital departments.

Exclusion Criteria:

* Personnel not consenting to participate

Sites / Locations

  • Carmel Medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthcare providers

Arm Description

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.

Outcomes

Primary Outcome Measures

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)
Qualitative quality of life assessment
Free-text narratives analysis using ATLAS.Ti software for systematic coding
Heart Rate Variability analysis
RMSSD parameter indicating parasympathetic activity

Secondary Outcome Measures

Full Information

First Posted
November 1, 2021
Last Updated
February 16, 2023
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05104827
Brief Title
Integrative Medicine Impact on Frontline COVID-19 Personnel Wellbeing
Official Title
Eran Ben-Arye is the Study Primary Investigator
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carmel Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wellbeing of Healthcare Providersin Frontline COVID-19 Departments
Keywords
Integrative medicine, Resilience, Covid-19, Quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective non-controlled study
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthcare providers
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Complementary Integrative Medicine
Other Intervention Name(s)
Acupuncture, acupressure, manual-movement, mind-body relaxation techniques
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quantitative quality of life assessment
Description
Concerns analysis based on Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire on a scale ranging from 9 (no concern) to 6 (worst)
Time Frame
48 hours
Title
Qualitative quality of life assessment
Description
Free-text narratives analysis using ATLAS.Ti software for systematic coding
Time Frame
48 hours
Title
Heart Rate Variability analysis
Description
RMSSD parameter indicating parasympathetic activity
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: * Healthcare providers and personnel working in frontline COVID-19 hospital departments. Exclusion Criteria: * Personnel not consenting to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eran Ben-Arye, MD
Phone
972528709282
Email
eranben@netvision.net.il
First Name & Middle Initial & Last Name or Official Title & Degree
Sameer Kasem, MD
Phone
972508573244
Email
samirqa@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eran Ben-Arye, MD
Organizational Affiliation
Medical director, Integrative Oncology Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel Medical center
City
Haifa
ZIP/Postal Code
35152
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eran Ben-Arye, MD
Phone
972528709282
Ext
0
Email
eranbe@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Eran Ben-Arye

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36346679
Citation
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.
Results Reference
derived

Learn more about this trial

Integrative Medicine Impact on Frontline COVID-19 Personnel Wellbeing

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