NCT05308537 Randomized Controlled Trial of the Mindful Compassion Care Program in Reducing Psychological Distress Amongst Nurses During the COVID-19 Pandemic
| NCT ID | NCT05308537 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universita di Verona |
| Condition | Burnout |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2023-01-27 |
| Primary Completion | 2023-02-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 33 participants in total. It began in 2023-01-27 with a primary completion date of 2023-02-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05308537 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 65 Years, studying Burnout. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05308537 currently recruiting?
Yes, NCT05308537 is actively recruiting participants. Contact the research team at antonio.lasalvia@univr.it for enrollment information.
Where is the NCT05308537 trial being conducted?
This trial is being conducted at Verona, Italy.
Who is sponsoring the NCT05308537 clinical trial?
NCT05308537 is sponsored by Universita di Verona. The trial plans to enroll 33 participants.