- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07699835
Efficacy of a Gamified Blended Mindfulness Program to Reduce Burnout, Stress, and Anxiety in Nursing Students: A Randomized Controlled Trial
Efficacy of a Gamified Blended Mindfulness Program to Reduce Burnout, Stress, and Anxiety in Nursing Students
The primary purpose of this randomized controlled trial is to evaluate the efficacy of a 12-week gamified blended mindfulness intervention in reducing academic burnout, perceived stress, and anxiety among first-year nursing students. Nursing students frequently face high academic and clinical demands that deplete their psychological resources, leading to high levels of stress and emotional exhaustion during their training. While mindfulness interventions can mitigate these negative effects, adherence to standard digital programs often remains a challenge.
To address this, the study investigates the impact of incorporating gamification elements into a mindfulness program. Participants are randomly assigned to one of three groups: a minimal-treatment control group, a standard blended mindfulness group, or a gamified blended mindfulness group. The intervention spans 12 weeks and consists of 24 guided meditation sessions (16 online and 8 in-person).
The central hypothesis is that the gamified architecture will act as a behavioral reinforcement mechanism, improving student adherence to the program. Consequently, researchers hypothesize that participants in the gamified group will exhibit significantly lower post-intervention levels of emotional exhaustion, perceived stress, and anxiety compared to those in both the standard mindfulness intervention and the control group.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ceuta
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Ceuta, Ceuta, Spain, 51005
- Ceuta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Enrolled as a first-year undergraduate nursing student at the Ceuta Campus of the University of Granada (Spain).
- Aged 18 years or older.
- Voluntarily provide informed consent prior to participation.
Exclusion Criteria:
- Pre-existing clinical diagnosis of anxiety or depressive disorders.
- Current use of prescribed psychotropic medications (concurrent psychopharmacological treatment).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Participants in this control cohort (CG) receive a single-session minimal psychoeducational intervention rather than a structured multi-week mindfulness program.
|
Participants receive baseline information regarding the definition and health effects of meditation, alongside advice on how to independently practice it using free sessions available on a mobile application.
|
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Active Comparator: Intervention Group 1
Participants in this group (IG1) receive a structured 12-week blended mindfulness-based stress-reduction program without any gamification elements.
|
A 12-week program consisting of 24 guided meditation sessions (16 online and 8 in-person).
Sessions are led by a mindfulness expert, last between 15 and 30 minutes, and focus on breathing techniques and guided meditation practices.
|
|
Experimental: Intervention Group 2
articipants in this group (IG2) receive the standard 12-week blended mindfulness program enhanced with a structured gamified architecture designed to increase adherence and engagement.
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A 12-week, 24-session blended mindfulness program (15-30 minutes per session) integrated with gamification elements.
Participants earn one point per completed session to enter a draw for a premium nursing training app subscription.
The system also provides weekly automated score updates and a final anonymized leaderboard.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Academic Burnout: Emotional Exhaustion
Time Frame: Baseline (T0) and immediately following the 12-week intervention period (T1).
|
Assessed using the Emotional Exhaustion subscale of the Maslach Burnout Inventory-Student Survey (MBI-SS).
This subscale consists of 5 items rated on a 7-point frequency scale ranging from 0 (never) to 6 (daily).
Higher scores indicate higher levels of emotional exhaustion.
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Baseline (T0) and immediately following the 12-week intervention period (T1).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Academic Burnout: Cynicism
Time Frame: Baseline (T0) and immediately following the 12-week intervention period (T1).
|
Assessed using the Cynicism subscale of the Maslach Burnout Inventory-Student Survey (MBI-SS).
It consists of 4 items rated on a 7-point scale (0 = never to 6 = daily).
Higher scores indicate higher levels of cynicism toward studies.
|
Baseline (T0) and immediately following the 12-week intervention period (T1).
|
|
Academic Burnout: Academic Efficacy
Time Frame: Baseline (T0) and immediately following the 12-week intervention period (T1).
|
ssessed using the Academic Efficacy subscale of the Maslach Burnout Inventory-Student Survey (MBI-SS).
It consists of 6 items rated on a 7-point scale (0 = never to 6 = daily).
Higher scores indicate higher levels of academic efficacy (considered a protective factor against burnout).
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Baseline (T0) and immediately following the 12-week intervention period (T1).
|
|
Perceived Stress
Time Frame: Baseline (T0) and immediately following the 12-week intervention period (T1).
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Assessed using the 10-item Perceived Stress Scale (PSS).
Higher total scores indicate higher levels of perceived stress.
|
Baseline (T0) and immediately following the 12-week intervention period (T1).
|
|
Anxiety
Time Frame: Baseline (T0) and immediately following the 12-week intervention period (T1).
|
Assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS).
This subscale consists of 7 items, each scored from 0 to 3, with subscale totals ranging from 0 to 21.
Higher scores indicate higher levels of anxiety symptomatology.
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Baseline (T0) and immediately following the 12-week intervention period (T1).
|
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Depression
Time Frame: Baseline (T0) and immediately following the 12-week intervention period (T1).
|
Assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS).
This subscale consists of 7 items, each scored from 0 to 3, with subscale totals ranging from 0 to 21.
Higher scores indicate higher levels of depressive symptomatology.
|
Baseline (T0) and immediately following the 12-week intervention period (T1).
|
|
Student Engagement
Time Frame: Baseline (T0) and immediately following the 12-week intervention period (T1).
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Evaluated using the 9-item short version of the Utrecht Work Engagement Scale for Students (UWES-9).
All items use a 0-6 frequency scale.
Higher scores indicate higher levels of academic work engagement.
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Baseline (T0) and immediately following the 12-week intervention period (T1).
|
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Dispositional Mindfulness
Time Frame: Baseline (T0) and immediately following the 12-week intervention period (T1).
|
Measured by the Mindful Attention Awareness Scale (MAAS).
This is a 15-item instrument designed to assess core characteristics of dispositional mindfulness, specifically open awareness and attention to the present moment.
Higher scores denote greater mindfulness.
|
Baseline (T0) and immediately following the 12-week intervention period (T1).
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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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4638/CEIH/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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