NCT07127809

Brief Summary

The goal of this clinical trial is to evaluate whether a mindfulness-based intervention can reduce job burnout and enhance psychological capital among hospital nurses. The study will involve female nurses aged 22-50 working in four tertiary hospitals in Taizhou, China. The main questions it aims to answer are: Can mindfulness practice improve nurses' psychological capital (as measured by the Psychological Capital Questionnaire, PCQ-24)? Can it reduce job burnout (as measured by the Maslach Burnout Inventory - General Survey, MBI-GS)? Is there a sustained effect over time (2 and 4 months post-intervention)? Researchers will compare the intervention group (mindfulness practice) with a control group (routine work, no additional intervention) to see if mindfulness leads to measurable improvements in psychological well-being and burnout symptoms. Participants will: Complete online questionnaires at baseline,and at 2 and 4 month follow-ups. Engage in a structured mindfulness practice program delivered via a mobile app (intervention group only). Continue their routine work responsibilities throughout the study period. This study also explores the influence of multilevel psychological capital-at the individual, organizational, and family levels-on nurse burnout, aiming to develop an evidence-based, scalable approach to address nurse mental health in high-stress healthcare environments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

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

May 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2025

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

July 18, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

Job burnoutMindfulness-based interventionPsychological capitalMultilevel analysis

Outcome Measures

Primary Outcomes (2)

  • Job Burnout Level measured by the Maslach Burnout Inventory - General Survey (MBI-GS)

    Evaluate the change in job burnout symptoms (emotional exhaustion, cynicism, and reduced professional efficacy) among nurses in the intervention group compared to control.

    Baseline, Day 40, and 2- and 4-month follow-ups

  • Psychological Capital Level measured by the Psychological Capital Questionnaire (PCQ-24)

    Assess the change in psychological capital, including self-efficacy, hope, resilience, and optimism among nurses receiving the mindfulness intervention compared to control.

    Baseline, Day 40, and 2- and 4-month follow-ups

Secondary Outcomes (1)

  • Mindfulness Level measured by the Five Facet Mindfulness Questionnaire (FFMQ)

    Baseline, Day 40, and 2- and 4-month follow-ups

Study Arms (2)

Mindfulness Practice

EXPERIMENTAL

Nurses receive structured mindfulness practice in addition to routine work.

Behavioral: Mindfulness Practice

Control Group

NO INTERVENTION

Nurses continue routine work without additional intervention.

Interventions

Participants in this group will engage in a structured mindfulness practice program delivered via a custom-developed mobile app. The intervention includes guided mindfulness exercises such as meditation, breathing techniques, and body awareness, designed to be practiced daily alongside routine nursing duties. The program aims to enhance psychological capital and reduce job burnout symptoms over a 40-day intervention period, with follow-up assessments at 2 and 4 months post-intervention.

Mindfulness Practice

Eligibility Criteria

Age22 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Registered nurses aged 22-50
  • Employed full-time in tertiary hospitals in Taizhou, China
  • Moderate or high levels of burnout (Maslach Burnout Inventory - General Survey screening)
  • Provided informed consent

You may not qualify if:

  • Diagnosed psychiatric disorders or ongoing psychotropic medication
  • Prior formal mindfulness training
  • Inability to use mobile applications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taizhou central hospital

Taizhou, Zhejiang, 318000, China

Location

MeSH Terms

Conditions

Burnout, PsychologicalPsychological Well-Being

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Nursing

Study Record Dates

First Submitted

July 18, 2025

First Posted

August 17, 2025

Study Start

May 1, 2024

Primary Completion

May 31, 2025

Study Completion

September 25, 2025

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD), including the final dataset and accompanying data dictionary, will be made available to researchers outside the primary study group.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
IPD will be available beginning 12 months after publication of the primary results and for a period of 5 years thereafter.
Access Criteria
Qualified researchers may request access by contacting the principal investigator at xiamengjie@tzc.edu.cn. Requests must include a methodologically sound research proposal and will require signing a data use agreement. Data will be shared via a secure, password-protected repository.

Locations