Clinical trial NCT05104827: Integrative Medicine Impact on Frontline COVID-19 Personnel Wellbeing
Official title: Eran Ben-Arye is the Study Primary Investigator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wellbeing of Healthcare Providersin Frontline COVID-19 Departments
Keywords: Integrative medicine
Resilience
Covid-19
Quality of life
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective non-controlled study
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

\* Personnel not consenting to participate

Primary outcomes:
measure: Quantitative quality of life assessment
timeFrame: 48 hours
measure: Qualitative quality of life assessment
timeFrame: 48 hours
measure: Heart Rate Variability analysis
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical center
Study officials:
affiliation: Medical director, Integrative Oncology Program
name: Eran Ben-Arye, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.