Burnout SyndromeNCT07699835
Efficacy of a Gamified Blended Mindfulness Program to Reduce Burnout, Stress, and Anxiety in Nursing Students: A Randomized Controlled Trial
A study testing Psychoeducation and Free App Recommendation, Standard Blended Mindfulness Program and Gamified Blended Mindfulness Program in people with Burnout Syndrome and Psychological Stress, Anxiety, and Depression Associated With Academic Pressure, run by Universidad de Granada at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout Syndrome, Psychological Stress, Anxiety, and Depression Associated With Academic Pressure, Anxiety
- What is being tested?
- Psychoeducation and Free App Recommendation, Standard Blended Mindfulness Program and Gamified Blended Mindfulness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pre-existing clinical diagnosis of anxiety or depressive disorders.
- Current use of prescribed psychotropic medications (concurrent psychopharmacological treatment).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Burnout Syndrome, Psychological Stress, Anxiety, and Depression Associated With Academic Pressure, Anxiety
- Being tested
- Psychoeducation and Free App Recommendation, Standard Blended Mindfulness Program, Gamified Blended Mindfulness Program
- Keywords
- Mental Health Promotion, Nursing Students
- Medical subject headings
- Burnout, Psychological, Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation and Free App RecommendationBehavioural
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.
Standard Blended Mindfulness ProgramBehavioural
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.
Gamified Blended Mindfulness ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants in this control cohort (CG) receive a single-session minimal psychoeducational intervention rather than a structured multi-week mindfulness program. Receives: Behavioral: Psychoeducation and Free App Recommendation |
| Intervention Group 1 | Active comparator | Participants in this group (IG1) receive a structured 12-week blended mindfulness-based stress-reduction program without any gamification elements. Receives: Behavioral: Standard Blended Mindfulness Program |
| Intervention Group 2 | Experimental | 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. Receives: Behavioral: Gamified Blended Mindfulness Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Academic Burnout: Emotional Exhaustion
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.
Measured: Baseline (T0) and immediately following the 12-week intervention period (T1).
Secondary outcomes (7)
Academic Burnout: Cynicism
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.
Measured: Baseline (T0) and immediately following the 12-week intervention period (T1).
Academic Burnout: Academic Efficacy
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).
Measured: Baseline (T0) and immediately following the 12-week intervention period (T1).
Perceived Stress
Assessed using the 10-item Perceived Stress Scale (PSS). Higher total scores indicate higher levels of perceived stress.
Measured: Baseline (T0) and immediately following the 12-week intervention period (T1).
Anxiety
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.
Measured: Baseline (T0) and immediately following the 12-week intervention period (T1).
Depression
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.
Measured: Baseline (T0) and immediately following the 12-week intervention period (T1).
Student Engagement
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.
Measured: Baseline (T0) and immediately following the 12-week intervention period (T1).
Dispositional Mindfulness
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.
Measured: Baseline (T0) and immediately following the 12-week intervention period (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Feb 2025
- Primary completion5 Sep 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María José Membrive Jiménez, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699835
- Sponsor's protocol ID
- 4638/CEIH/2024
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Gamified Blended Mindfulness Program to Reduce Burnout, Stress, and Anxiety in Nursing Students
- ClinicalTrials.gov ID
- NCT07699835
- Acronym / sponsor ID
- 4638/CEIH/2024
- Conditions
- Burnout Syndrome, Psychological Stress, Anxiety, and Depression Associated With Academic Pressure, Anxiety
- Keywords
- Mental Health Promotion, Nursing Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Psychoeducation and Free App RecommendationParticipants in this control cohort (CG) receive a single-session minimal psychoeducational intervention rather than a structured multi-week mindfulness program. |
| Intervention Group 1 | Active comparator | Behavioral: Standard Blended Mindfulness ProgramParticipants in this group (IG1) receive a structured 12-week blended mindfulness-based stress-reduction program without any gamification elements. |
| Intervention Group 2 | Experimental | Behavioral: Gamified Blended Mindfulness Programarticipants in this group (IG2) receive the standard 12-week blended mindfulness program enhanced with a structured gamified architecture designed to increase adherence and engagement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Pre-existing clinical diagnosis of anxiety or depressive disorders.
- Current use of prescribed psychotropic medications (concurrent psychopharmacological treatment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation and Free App RecommendationParticipants 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. | Behavioural | Control Group |
| Standard Blended Mindfulness ProgramA 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. | Behavioural | Intervention Group 1 |
| Gamified Blended Mindfulness ProgramA 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. | Behavioural | Intervention Group 2 |
Primary outcome
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.
7 secondary outcomes
Academic Burnout: Cynicism
Time frame: 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).
Perceived Stress
Time frame: 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).
Depression
Time frame: 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).
Dispositional Mindfulness
Time frame: Baseline (T0) and immediately following the 12-week intervention period (T1).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation and Free App Recommendation, Standard Blended Mindfulness Program and Gamified Blended Mindfulness Program in people with Burnout Syndrome and Psychological Stress, Anxiety, and Depression Associated With Academic Pressure, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Academic Burnout: Emotional Exhaustion (time frame: Baseline (T0) and immediately following the 12-week intervention period (T1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.