NCT05515172

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
371

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

August 23, 2022

Last Update Submit

August 23, 2022

Conditions

Keywords

mindfulnessresilienceCOVID-19nurses

Outcome Measures

Primary Outcomes (7)

  • Change from Baseline to 6 months follow-up of Subjective Well-being

    Subjective Well-Being will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.

    At baseline, and 6 months follow-up

  • Change from Baseline to 6 months follow-up of Negative Emotions

    Negative Emotions will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.

    At baseline, and 6 months follow-up

  • Change from Baseline to 6 months follow-up of Perception of Health

    Perception of Health will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.

    At baseline, and 6 months follow-up

  • Change from Baseline to 6 months follow-up of Stress

    Stress will be measured using the perceived stress scale.

    At baseline and 6 months follow-up

  • Change from Baseline to 6 months follow-up of Resilience

    Resilience will be measured using the brief resilience scale

    At baseline and 6 months follow-up

  • Change from Baseline to 6 months follow-up of mindfulness

    Resilience will be measured using the mindfulness-awareness attention scale

    At baseline and 6 months follow-up

  • Change from Baseline to 6 months follow-up of burnout

    Burnout will be measured using the Burnout Clinical Subtypes Questionnaire

    At baseline and 6 months follow-up

Study Arms (1)

Intervention group

EXPERIMENTAL

Mindfulness-based intervention is composed of micropractices, cohesion groups, affirmations, and journaling. This was administered via a webpage designed for this intervention.

Other: Mindfulness-based Intervention

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent

You may not qualify if:

  • Lack of signature in the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TecSalud

San Pedro Garza García, Nuevo León, 66278, Mexico

Location

Related Publications (1)

  • Cepeda-Lopez AC, Solis Dominguez L, Villarreal Zambrano S, Garza-Rodriguez IY, Del Valle AC, Quiroga-Garza A. A comparative study of well-being, resilience, mindfulness, negative emotions, stress, and burnout among nurses after an online mind-body based intervention during the first COVID-19 pandemic crisis. Front Psychol. 2023 Mar 13;14:848637. doi: 10.3389/fpsyg.2023.848637. eCollection 2023.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 25, 2022

Study Start

April 1, 2020

Primary Completion

May 30, 2020

Study Completion

April 1, 2021

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations