- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07804927
STRess Assessment of INterventional Cardiology Fellows and Attendings
31. august 2026 oppdatert av: Minneapolis Heart Institute Foundation
Interventional cardiology (IC) fellows and attendings experience high levels of stress.
In a recent study, IC fellowship was considered very stressful by 22%, somewhat stressful by 62%, and not stressful by 16%(1).
In a different study, 29% of the IC fellows considered leaving their job during the past year, while more than a quarter (29%) felt overwhelmed ≥3x/week(2).
Moreover, the same study reports that burnout affects 69% of the interventional cardiologists.
In addition, in the Medscape Cardiologist Lifestyle, Happiness & Burnout Report 2023, 43% of the cardiologists in general reported being burned out and 23% were depressed(3).
However, it remains unknown whether they deal with increased stress before, during, and after a procedure, if their stress decreases (and if so, how much) with experience, and how they recover after a procedure.
The present study will study the stress levels of IC fellows and attendings using various subjective metrics and wearable devices.
Studieoversikt
Status
Rekruttering
Forhold
Studietype
Observasjonsmessig
Registrering (Antatt)
15
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Minnesota
-
Minneapolis, Minnesota, Forente stater, 55407
- Rekruttering
- Minneapolis Heart Institute Foundation
-
Ta kontakt med:
- Bavana V Rangan, BDS, MPH
- Telefonnummer: 817-821-9945
- E-post: bavana.rangan@allina.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
N/A
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The target study population is all interventional cardiology attendings and fellows at Minneapolis Heart Institute.
Beskrivelse
Inclusion Criteria:
- Interventional Cardiology fellow or attending.
- Age 18 years or older.
- Willing and able to provide informed consent.
- Access to smartphone (Apple or Android platform).
- Willing and able to wear the wearable devices.
Exclusion Criteria:
1- Any health condition that in the opinion of the investigator would preclude individual's participation in the study such as conditions that would preclude them from wearing the study wearables and participating to provide wearable data.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Heart Rate Variability (HRV)
Tidsramme: From enrollment to end of study period at 14 days
|
Heart Rate Variability (HRV) as assessed by the wearable devices
|
From enrollment to end of study period at 14 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Stress
Tidsramme: Baseline and at the end of study period at 14 days
|
Subjective stress assessed by the STAI-short version at baseline, before and after a procedure.
Higher scores on the STAI indicate greater anxiety
|
Baseline and at the end of study period at 14 days
|
|
Procedural characteristics
Tidsramme: Perioperative
|
Procedural characteristics as assessed by the post-procedural questionnaire
|
Perioperative
|
|
Burnout
Tidsramme: From enrollment to end of study period at 14 days
|
Burnout as assessed by the Mini-Z survey.
A higher score indicates increased burnout
|
From enrollment to end of study period at 14 days
|
|
Heart Rate
Tidsramme: From enrollment to end of study period at 14 days
|
Heart rate as assessed by the wearable device(s).
|
From enrollment to end of study period at 14 days
|
|
Sleep
Tidsramme: From enrollment to end of study period at 14 days
|
Sleep metrics as assessed by the wearable device(s).
|
From enrollment to end of study period at 14 days
|
|
Blood oxygen
Tidsramme: From enrollment to end of study period at 14 days
|
Blood oxygen as assessed by the wearable device(s).
|
From enrollment to end of study period at 14 days
|
|
Respiratory rate
Tidsramme: From enrollment to end of study period at 14 days
|
Respiratory rate as assessed by the wearable device(s).
|
From enrollment to end of study period at 14 days
|
|
Body temperature
Tidsramme: From enrollment to end of study period at 14 days
|
Body temperature as assessed by the wearable device(s).
|
From enrollment to end of study period at 14 days
|
|
Workout metrics
Tidsramme: From enrollment to end of study period at 14 days
|
Workout metrics as assessed by the wearable device(s).
|
From enrollment to end of study period at 14 days
|
|
Energy consumption
Tidsramme: From enrollment to end of study period at 14 days
|
Energy consumption as assessed by the wearable device(s).
|
From enrollment to end of study period at 14 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. oktober 2023
Primær fullføring (Antatt)
4. oktober 2027
Studiet fullført (Antatt)
4. oktober 2027
Datoer for studieregistrering
Først innsendt
17. august 2026
Først innsendt som oppfylte QC-kriteriene
31. august 2026
Først lagt ut (Faktiske)
4. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- STRAIN
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .