NCT06612749

Brief Summary

The study assesses integrative medicine intervention effects on healthcare providers' quality-of-life during wartime.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 25, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

August 25, 2024

Last Update Submit

September 24, 2024

Conditions

Keywords

ResilienceIntegrative medicineHealthcare providersAcupuncture

Outcome Measures

Primary Outcomes (2)

  • Assessing HCPs QoL-related concerns using the Measure Yourself Concerns and Wellbeing (MYCAW).

    The MYCAW asks patients to list their two most significant concerns and general feeling of wellbeing (from 0, "doesn't bother me at all"; to 6, "bothers me greatly"). At post-treatment, the HCPs are asked to re-score the two original leading concerns and general well-being, followed by two open-ended questions about "Other things affecting your health"; and "What has been most important for you?" with respect to the IM treatments they had received. In the post-intervention narratives, HCPs are asked to describe the most important aspects of their treatment. HCP narratives are considered as free-text narratives, which may be qualitatively analyzed using ATLAS.Ti software for systematic coding, to identify clusters of emotional-spiritual keywords (ESKs), such as "calming", "release", "relaxation" and "disengagement".

    Before and immediately following the IO intervention; and at 24-48 hours post-treatment.

  • Assessment of objective physiological changes during the intervention

    Assessment of objective physiological changes during the 30-minute intervention are conducted using chest-lead electrocardiogram monitoring autonomic heart rate variability (HRV) throughout the intervention.

    During the 30 minutes intervention

Study Arms (1)

Integrative medicine intervention

EXPERIMENTAL

Healthcare providers were treated for 30 minutes with integrative medicine based on manual and mind-body modalities

Other: Integrative medicine including manual and/or mind-body treatments

Interventions

Referred HCPs are recommended a multi-modal IM program, include at least one of the following: acupuncture; manual-movement therapies (e.g., acupressure, Anthroposophic medicine touch therapies, reflexology, Qi Gong, and Feldenkrais method); and mind-body medicine (e.g., relaxation and breathing techniques).

Also known as: Acupuncture, Relaxation, Acupressure
Integrative medicine intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare providers reporting war-related concerns affecting their quality of life

You may not qualify if:

  • \* Healthcare providers with no quality-of-life related concerns they attribute to the war r

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical center

Haifa, Israel

RECRUITING

Related Publications (3)

  • Ben-Arye E, Gressel O, Samuels N, Stein N, Eden A, Vagedes J, Kassem S. Complementary and integrative medicine intervention in front-line COVID-19 clinicians. BMJ Support Palliat Care. 2022 Apr 5:bmjspcare-2021-003333. doi: 10.1136/bmjspcare-2021-003333. Online ahead of print.

    PMID: 35383045BACKGROUND
  • 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.

    PMID: 36346679BACKGROUND
  • Kassem S, Vagedes J, Gressel O, Samuels N, Elias S, Ben-Arye E. Spirit and Sense: Autonomic Response to Integrative Medicine Intervention for Health Care Personnel During Wartime. Biopsychosoc Sci Med. 2025 Jul-Aug 01;87(6):380-387. doi: 10.1097/PSY.0000000000001402. Epub 2025 Jun 11.

MeSH Terms

Interventions

Acupuncture TherapyAcupressure

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsTherapy, Soft TissueMusculoskeletal ManipulationsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Eran Ben-Arye, MD

CONTACT

Sameer Kassem, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Integrative Medicine Program

Study Record Dates

First Submitted

August 25, 2024

First Posted

September 25, 2024

Study Start

October 23, 2023

Primary Completion

March 31, 2025

Study Completion

September 1, 2025

Last Updated

September 25, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations