Integrative Medicine Impact on Frontline COVID-19 Personnel Wellbeing

February 16, 2023 updated by: Eran Ben-Arye, Carmel Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Haifa, Israel, 35152
        • Recruiting
        • Carmel Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

* Personnel not consenting to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthcare providers
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.
Other: Complementary Integrative Medicine
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.
Other Names:
  • Acupuncture, acupressure, manual-movement, mind-body relaxation techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
48 hours
Qualitative quality of life assessment
Time Frame: 48 hours
Free-text narratives analysis using ATLAS.Ti software for systematic coding
48 hours
Heart Rate Variability analysis
Time Frame: 30 minutes
RMSSD parameter indicating parasympathetic activity
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Investigators

  • Principal Investigator: Eran Ben-Arye, MD, Medical director, Integrative Oncology Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-20-0202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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