ClinicalTrials.gg
RecruitingNCT06612749Updated Sep 25, 2024

Assessing the Impact of Integrative Medicine on Anxiety and Wellbeing of Healthcare Providers Exposed to Terror or War

An interventional study of Integrative medicine including manual and/or mind-body treatments in Quality of Life, sponsored by Carmel Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-25.

Sponsored by Carmel Medical Center · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Registered 10 months after the study started (first participant enrolled Oct 2023, registered Aug 2024).
  • Started Oct 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study summary

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

Read the detailed description

The study is prospective, non-randomized and non-controlled, and taking place at the Carmel Medical Center in Haifa, northern Israel, from October 2023. The study was launched in proximity with the outbreak of the October 2023 war in the Middle East. As this timing was and is still regarded in Israel as an emergency life-threatening situation and considering the research limitation to healthcare providers only, the Carmel Medical Center Institutional Review Board has exempted the study from requiring written consent from participants, after reviewing the study protocol. However, Participation in the study was voluntary, and no incentive, financial or other was offered.

The hospital administration and department refer healthcare providers (HCPs) to integrative medicine intervention those if reporting emotional, physical, or other QoL concerns directly or indirectly related to the current conflict in Israel. The IM intervention entails a 30-minute treatment session, with an additional 10 minutes allocated for both pre- and post- treatment assessment. IM treatments are individually tailored to the HCP's QoL-related concerns, taking into consideration their willingness to undergo the recommended modalities. In all cases, a multi-modal IM program is recommended, which includes 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). During these treatments participants are asked to lay on a treatment bed, with relaxed non-paced breathing throughout the session. The IM treatments are provided by IM-trained therapists who work in an integrative oncology setting.

02

Conditions studied

  • Quality of Life

Keywords

  • Resilience
  • Integrative medicine
  • Healthcare providers
  • Acupuncture
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In context

Lead sponsor

Carmel Medical Center is the lead sponsor of 119 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Integrative medicine intervention

    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

  • OtherIntegrative medicine including manual and/or mind-body treatments

    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

06

What researchers measure

Primary outcomes

  1. 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".

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

  2. 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.

    Time frame: During the 30 minutes intervention

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 35383045 ↗
  • 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. PubMed 36346679 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06612749
Responsible party
Eran Ben-Arye (Director, Integrative Medicine Program, Carmel Medical Center) — Principal investigator
First posted
Sep 25, 2024
Start date
Oct 23, 2023
Primary completion
Mar 31, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Sep 25, 2024

Study contacts

Eran Ben-Arye, MD
Contact
ERANBE@clalit.org.il
+972528709282
Sameer Kassem, MD
Contact
samirqa@clalit.org.il
+972508573244

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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