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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05515172
Other study ID # 20191210-CEI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2020
Est. completion date April 1, 2021

Study information

Verified date August 2022
Source Universidad de Monterrey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 371
Est. completion date April 1, 2021
Est. primary completion date May 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Signed informed consent Exclusion Criteria: - Lack of signature in the informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mindfulness-based Intervention
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.

Locations

Country Name City State
Mexico TecSalud San Pedro Garza Garcia Nuevo Leon

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Monterrey

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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