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

September 24, 2024 updated by: Eran Ben-Arye, Carmel Medical Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

600

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
        • Recruiting
        • Carmel Medical Center
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: 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
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).
Other Names:
  • Acupuncture
  • Relaxation
  • Acupressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing HCPs QoL-related concerns using the Measure Yourself Concerns and Wellbeing (MYCAW).
Time Frame: Before and immediately following the IO intervention; and at 24-48 hours post-treatment.
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
Time Frame: During the 30 minutes 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

Collaborators and Investigators

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

Sponsor

Carmel Medical Center

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)

October 23, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

August 25, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15102023

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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