NCT07468240

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

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

June 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 30, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

January 30, 2026

Last Update Submit

March 11, 2026

Conditions

Keywords

Burnout, ProfessionalAnxiety, ExistentialClinical Decision-MakingMindfulnessNurses

Outcome Measures

Primary Outcomes (1)

  • Burnout

    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).

    12 weeks

Secondary Outcomes (1)

  • Clinical decision-making

    12 weeks

Other Outcomes (1)

  • Existential anxiety

    12 weeks

Study Arms (2)

Mindfulness-Based Psychoeducation Program

EXPERIMENTAL

Participants receive a mindfulness-based psychoeducational program.

Behavioral: Mindfulness-Based Psychoeducational Program

No Intervention

NO INTERVENTION

Participants receive no intervention during the study period.

Interventions

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.

Mindfulness-Based Psychoeducation Program

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Düzce University Hospital

Düzce, Centre, 81000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Burnout, PsychologicalBurnout, ProfessionalAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorOccupational StressOccupational DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study uses a parallel-group randomized design. Eligible participants are randomly assigned to either an intervention group receiving a mindfulness-based psychoeducational program or a control group receiving no intervention during the study period. Outcomes are assessed at baseline and post-intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

March 12, 2026

Study Start

June 1, 2025

Primary Completion

December 22, 2025

Study Completion

December 22, 2025

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical considerations and the sensitive nature of psychological data collected from participants.

Locations