Clinical Trials in Italy / NCT05308537
Recruiting Not applicable

Randomized Controlled Trial of the Mindful Compassion Care Program in Reducing Psychological Distress Amongst Nurses During the COVID-19 Pandemic

NCT05308537 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2023-01-27
Last updated
2024-11-25

Condition(s) studied

BurnoutCOVID-19

Investigational drug(s) / intervention(s)

Mindful Compassion Care Program

Mindful Compassion Care Program: The intervention is a proven effective mindfulness programme based on well-known scientific programmes such as mindfulness-based stress reduction mindfulness-based cognitive therapy and compassion focused therapy.

Study summary

Recent studies have shown that nurses have been more affected by the COVID-19 pandemic than any other group of hospital workers in terms of anxiety, depression, and burnout. Several clinical studies had previously demonstrated the effectiveness of mindfulness and compassion interventions in reducing burnout and emotional distress amongst healthcare professionals. A parallel-group randomized controlled trial will assess the feasibility, acceptability, and efficacy of a mindfulness and compassion-focused programme on frontline nurses who had been working during the COVID-19 pandemic. Seventy-two participants will be divided equally into an intervention group and a control group. Primary outcome will be assessed using the Emotional Exhaustion subscale of the Maslach Burnout Inventory General Survey (MBI-GS). Secondary outcomes will be measured by the Cynicism and Professional Efficacy subscales of the MBI-GS; the Patient Health Questionnaire (PHQ-9); the Generalized Anxiety Disorder (GAD-7); the Insomnia Severity Index (ISI); the Impact of Stressful Events (IES-R); the Perceived Stress Scale (PSS); the Five Facet Mindfulness Questionnaire (FFMQ); and the Forms of Self-Criticising/attacking and Self-Reassuring Scale (FSCRS). The study aims to fill a gap in the literature and present a scientifically validated intervention for those healthcare professionals most exposed to the stressful conditions of working during the COVID-19 pandemic.

Eligibility

Sex
ALL
Min age
25 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: To be included in the study, a participants will have to be: * a nurse employed at AOUI for the past two years; * working within intensive care units, infectious disease unit, pulmonary medicine and internal medicine units that have been converted to COVID-19 sub-intensive units; * scoring above the cut-off score for the Emotional Exhaustion sub-scale (EX) of the MBI-GS (equal to or greater than 2.20) in accordance with Italian norms Exclusion Criteria: Respondents will be excluded if they: * have participated in mindfulness-based interventions in the previous 6 months; * show a score \< 2.20 in the EX subscale of the MBI-GS; * are receiving psychosocial or psychiatric treatment. Participants allocated to the WL will be requested not to participate in a mindfulness course offered elsewhere.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Università di Verona Verona Italia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05308537 on ClinicalTrials.gov ↗ ← All trials in Italy