Clinical trial NCT06612749: Assessing the Impact of Integrative Medicine on Anxiety and Wellbeing of Healthcare Providers Exposed to Terror or War
Official title: Assessing the Impact of Integrative Medicine on Anxiety and Wellbeing of Healthcare Providers Exposed Directly or Indirectly to Terror, Trauma or War
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Quality of Life
Keywords: Resilience
Integrative medicine
Healthcare providers
Acupuncture
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessing HCPs QoL-related concerns using the Measure Yourself Concerns and Wellbeing (MYCAW).
timeFrame: Before and immediately following the IO intervention; and at 24-48 hours post-treatment.
measure: Assessment of objective physiological changes during the intervention
timeFrame: During the 30 minutes intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical center
Study officials:
References:
citation: 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.
citation: 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.