- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05104827
Integrative Medicine Impact on Frontline COVID-19 Personnel Wellbeing
Eran Ben-Arye er studiens primæretterforsker
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Background: Treating COVID-19 hospitalized patients incurred heavy burden of physical and emotional stress. The present study is taking place at Carmel Medical Center in collaboration with the integrative oncology and the internal medicine teams with aim to improve the wellbeing of healthcare providers working in frontline COVID-19 departments.
Purpose: To explore the impact of personalized integrative oncology modalities on the physical and emotional concerns as well as physiological parameters (e.g., Heart Rate Variability, HRV) of healthcare practitioners (HCPs) in COVID-19 department.
Methods: In this prospective preference study, HCPs working inside COVID-19 departments are referred to integrative oncology-trained practitioners for assessment of their two leading concerns followed by 30-minute individually tailored treatment, scheduled during the working shift and performed adjacent to the COVID department. Integrative treatment include one or more of the following modalities: acupuncture, manual (e.g., acupressure, anthroposophic medicine, reflexology), movement (QiGong, Feldenkrais and Paula methods), and mind-body therapies. The Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire is used for pre- and post-treatment quantitative and qualitative assessment. HCP's narratives analysis is purposed to identify concerns and impact of the integrative treatment program.
HRV is assessed during the integrative treatment. Three minutes intervals at start and after 20 minutes are used for pre- and post-treatment assessment. The primary outcome is RMSSD (root square of successive differences) indicating parasympathetic activity. Secondary outcomes are further parameters from the time domain analysis (SDNN, pNN50) and frequency domain analysis (LF/HF Ratio).
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Eran Ben-Arye, MD
- Telefonnummer: 972528709282
- E-post: eranben@netvision.net.il
Studer Kontakt Backup
- Navn: Sameer Kasem, MD
- Telefonnummer: 972508573244
- E-post: samirqa@clalit.org.il
Studiesteder
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Haifa, Israel, 35152
- Rekruttering
- Carmel Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
* Healthcare providers and personnel working in frontline COVID-19 hospital departments.
Exclusion Criteria:
* Personnel not consenting to participate
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Healthcare providers
Healthcare providers employed in COVID-19 departments are referred to integrative oncology-trained practitioners for an evaluation of their two main concerns, followed by a 30-minute individually tailored integrative care.
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30-minute individually tailored integrative medicine care, including acupuncture, acupressure, reflexology, movement therapies like QiGong or Feldenkrais as well as Anthroposophic Medicine and mind-body treatments.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Quantitative quality of life assessment
Tidsramme: 48 timer
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Concerns analysis based on Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire on a scale ranging from 9 (no concern) to 6 (worst)
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48 timer
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Qualitative quality of life assessment
Tidsramme: 48 hours
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Free-text narratives analysis using ATLAS.Ti software for systematic coding
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48 hours
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Heart Rate Variability analysis
Tidsramme: 30 minutes
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RMSSD parameter indicating parasympathetic activity
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30 minutes
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Eran Ben-Arye, MD, Medical director, Integrative Oncology Program
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMC-20-0202
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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