- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05515172
Resilience Intervention for Health Professionals COVID-19
23. august 2022 opdateret af: Universidad de Monterrey
Resilience Intervention in Times of Crisis for Health Professionals During the COVID-19 Contingency
In the fight against the coronavirus (COVID-19) pandemic, health personnel, especially nursing staff, have been facing enormous pressure, including a high risk of infection and inadequate protection against contamination, overwork, frustration, discrimination, isolation, lack of contact with their families and exhaustion.
Therefore, the World Health Organization (WHO) has requested particular interventions to promote emotional well-being in health workers exposed to COVID-19, which must be implemented immediately, especially those aimed at women and nursing staff. .
Psychological support services, including counseling or intervention via phone, internet, and apps, have been widely deployed by local and national mental health institutions in response to the COVID-19 outbreak.
Complementing these efforts, the present study seeks, through mind-body medicine strategies, to promote resilience among nurses exposed to COVID-19 in critical phases.
A multidisciplinary team of expert volunteers designed the intervention in different mind-body medicine techniques (for example, medicine, psychology, thanatology, meditation, health, and wellness coaches, certified Qi Gong, and yoga instructors) and is made up of 3 components main: "micropractices," cohesion and support groups, which will be implemented for 12 weeks in health personnel.
This intervention responds to the international call to promote health personnel's physical and emotional health during the COVID-19 pandemic, offering an opportunity to accompany them during this time and mitigate the effects on health in the short and long term.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
371
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Nuevo Leon
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San Pedro Garza Garcia, Nuevo Leon, Mexico, 66278
- TecSalud
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Signed informed consent
Exclusion Criteria:
- Lack of signature in the informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Intervention group
Mindfulness-based intervention is composed of micropractices, cohesion groups, affirmations, and journaling.
This was administered via a webpage designed for this intervention.
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The intervention was designed by a volunteer multidisciplinary team expert in different mind-body medicine techniques (for example, medicine, psychology, thanatology, meditation, health, and wellness coaches, certified Qi Gong, and yoga instructors) and is made up of 3 components main: "micropractices," cohesion and support groups, which will be implemented for a period of 12 weeks.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline to 6 months follow-up of Subjective Well-being
Tidsramme: At baseline, and 6 months follow-up
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Subjective Well-Being will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.
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At baseline, and 6 months follow-up
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Change from Baseline to 6 months follow-up of Negative Emotions
Tidsramme: At baseline, and 6 months follow-up
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Negative Emotions will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.
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At baseline, and 6 months follow-up
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Change from Baseline to 6 months follow-up of Perception of Health
Tidsramme: At baseline, and 6 months follow-up
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Perception of Health will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.
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At baseline, and 6 months follow-up
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Change from Baseline to 6 months follow-up of Stress
Tidsramme: At baseline and 6 months follow-up
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Stress will be measured using the perceived stress scale.
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At baseline and 6 months follow-up
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Change from Baseline to 6 months follow-up of Resilience
Tidsramme: At baseline and 6 months follow-up
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Resilience will be measured using the brief resilience scale
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At baseline and 6 months follow-up
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Change from Baseline to 6 months follow-up of mindfulness
Tidsramme: At baseline and 6 months follow-up
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Resilience will be measured using the mindfulness-awareness attention scale
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At baseline and 6 months follow-up
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Change from Baseline to 6 months follow-up of burnout
Tidsramme: At baseline and 6 months follow-up
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Burnout will be measured using the Burnout Clinical Subtypes Questionnaire
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At baseline and 6 months follow-up
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2020
Primær færdiggørelse (Faktiske)
30. maj 2020
Studieafslutning (Faktiske)
1. april 2021
Datoer for studieregistrering
Først indsendt
23. august 2022
Først indsendt, der opfyldte QC-kriterier
23. august 2022
Først opslået (Faktiske)
25. august 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. august 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. august 2022
Sidst verificeret
1. august 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20191210-CEI
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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