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NCT Number: NCT06612749

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

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

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Key information

Conditions

Quality of Life

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrative medicine including manual and/or mind-body treatments

Other

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

Primary outcomes

  1. 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".

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eran Ben-Arye, MD

CONTACT

[email protected]

+972528709282

Sameer Kassem, MD

CONTACT

[email protected]

+972508573244

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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