NCT05104827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

3 years

First QC Date

November 1, 2021

Last Update Submit

August 20, 2024

Conditions

Keywords

Integrative medicineResilienceCovid-19Quality of life

Outcome Measures

Primary Outcomes (3)

  • 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)

    48 hours

  • Qualitative quality of life assessment

    Free-text narratives analysis using ATLAS.Ti software for systematic coding

    48 hours

  • Heart Rate Variability analysis

    RMSSD parameter indicating parasympathetic activity

    30 minutes

Study Arms (1)

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.

Other: Complementary Integrative Medicine

Interventions

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.

Also known as: Acupuncture, acupressure, manual-movement, mind-body relaxation techniques
Healthcare providers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \* Personnel not consenting to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical center

Haifa, 35152, Israel

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19

Interventions

Acupuncture TherapyAcupressure

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsTherapy, Soft TissueMusculoskeletal ManipulationsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Eran Ben-Arye, MD

    Medical director, Integrative Oncology Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Prospective non-controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate professor

Study Record Dates

First Submitted

November 1, 2021

First Posted

November 3, 2021

Study Start

December 31, 2020

Primary Completion

December 31, 2023

Study Completion

June 1, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations