- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07468240
Mindfulness-Based Psychoeducation for Burnout, Decision-Making, and Existential Anxiety in High-Risk Unit Nurses (MINDEX)
The Effect of a Mindfulness-Based Psychoeducation Program on Burnout, Clinical Decision-Making, and Existential Anxiety in Nurses Working in High-Risk Units
High-risk units, including intensive care, oncology, and emergency services, are clinical environments characterized by rapid decision-making demands and heavy workloads, placing substantial emotional and physical strain on nurses and other healthcare professionals. These challenging working conditions may contribute to burnout, negatively influence clinical decision-making processes, and increase levels of existential anxiety. Frequent exposure to death and critical illness can intensify nurses' confrontation with themes such as meaning, responsibility, and psychological resilience within their professional roles.
Existential anxiety involves fundamental human concerns related to life, death, freedom, responsibility, and meaning, which may become more salient in high-risk healthcare settings. In recent years, mindfulness-based approaches have gained attention as effective interventions for supporting healthcare professionals. Mindfulness emphasizes present-moment awareness and a nonjudgmental attitude toward thoughts and emotions, and has been shown to help individuals cope with stress and emotional burden more adaptively.
This study aims to evaluate the effects of a mindfulness-based psychoeducation program on burnout, clinical decision-making, and existential anxiety among nurses working in high-risk units, including intensive care, oncology, and emergency services. The findings of this study are expected to contribute to the development of supportive interventions that may enhance nurses' psychological well-being, professional functioning, and the overall quality of patient care.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Centre
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Düzce, Centre, Turkey (Türkiye), 81000
- Düzce University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Registered nurses working in high-risk clinical units, including intensive care units, oncology departments, and emergency services.
- Having at least one year of professional nursing experience.
- Willingness to participate in the study on a voluntary basis, with provision of informed consent.
Exclusion Criteria:
- Having a current or past diagnosis of a psychiatric disorder, such as schizophrenia, major depressive disorder, or bipolar disorder.
- Inability to complete the intervention program, defined as attendance of less than 70% of the scheduled sessions.
- Being pregnant or in the postpartum period, due to potential physical and psychological vulnerability during these stages.
- Presence of active suicidal ideation or a history of severe psychological trauma.
- Current use of psychoactive medication or ongoing intensive psychological treatment, including psychotherapy and/or pharmacological interventions.
- Previous participation in a mindfulness-based psychoeducational program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness-Based Psychoeducation Program
Participants receive a mindfulness-based psychoeducational program.
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The mindfulness-based psychoeducational program is a structured, group-based intervention designed for nurses working in high-risk hospital units.
The program includes mindfulness practices, psychoeducational content, and experiential exercises aimed at enhancing awareness, emotional regulation, and adaptive coping with work-related psychological challenges.
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No Intervention: No Intervention
Participants receive no intervention during the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Burnout
Time Frame: 12 weeks
|
Burnout Scale - Short Version: The scale was developed by Maslach and Pines (2005) to assess individuals' levels of burnout and was adapted into Turkish by Tümkaya et al. (2009), who conducted validity and reliability analyses.
The Short Version of the Burnout Scale is a unidimensional instrument consisting of 10 items rated on a seven-point Likert scale (1 = never, 2 = almost never, 3 = rarely, 4 = sometimes, 5 = often, 6 = very often, 7 = always).
Higher scores obtained from the scale indicate higher levels of burnout.
In the Turkish adaptation study conducted by Tümkaya et al. (2009), the Cronbach's alpha coefficient was reported as 0.91 (Tümkaya, Sabahattin, & Çavuşoğlu, 2009).
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical decision-making
Time Frame: 12 weeks
|
Nursing Anxiety and Self-Confidence with Clinical Decision Making (NASC-CDM©) Scale: The NASC-CDM© was developed by White and adapted into Turkish by Bektaş et al.
The 27-item, six-point Likert scale assesses self-confidence and anxiety separately in clinical decision-making.
Both subscales include three dimensions: (1) using resources and listening fully to obtain information, (2) using available information to identify the problem, and (3) knowing and taking action.
Higher scores on the self-confidence subscale indicate greater clinical decision-making confidence, whereas lower scores on the anxiety subscale indicate lower anxiety.
Scores for each subscale range from 27 to 162.
In the Turkish study, Cronbach's alpha was 0.97 (self-confidence) and 0.96 (anxiety).
In the present study, alpha coefficients were 0.98 and 0.94, respectively.
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12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Existential anxiety
Time Frame: 12 weeks
|
Existential Concerns Questionnaire (ECQ): The original form of the scale was developed by van Bruggen, Klooster, Westerhof, Vos, Kleine, Bohlmeijer, and Glas (2017), and it was adapted into Turkish by Ümmet, Ekşi, Özkapu, and Ekşi (2018).
The ECQ consists of 22 items rated on a five-point Likert scale and includes three subscales: general existential anxiety (13 items), death anxiety (5 items), and avoidance (4 items).
Total scores range from 22 to 110, with higher scores indicating higher levels of existential anxiety.
In reliability analyses, the test-retest coefficients were reported as 0.81 for the general anxiety subscale, 0.73 for the death anxiety subscale, 0.69 for the avoidance subscale, and 0.87 for the total scale.
Cronbach's alpha coefficients were 0.85 for general anxiety, 0.72 for death anxiety, 0.62 for avoidance, and 0.88 for the total scale (Ümmet et al., 2018).
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12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AYBU-ETK-2025/1235
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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