Efficacy of a Gamified Blended Mindfulness Program to Reduce Burnout, Stress, and Anxiety in Nursing Students: A Randomized Controlled Trial

NCT07699835 | Completed DMC

• 1 other identifier: 4638/CEIH/2024
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief 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. 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; Anxiety; Psychological Stress, Anxiety, and Depression Associated With Academic Pressure

Keywords

Mental Health Promotion; Nursing Students

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (T0) and immediately following the 12-week intervention period (T1).

Secondary Outcomes (7)

• Academic Burnout: Cynicism

  Baseline (T0) and immediately following the 12-week intervention period (T1).

• Academic Burnout: Academic Efficacy

  Baseline (T0) and immediately following the 12-week intervention period (T1).

• Perceived Stress

  Baseline (T0) and immediately following the 12-week intervention period (T1).

• Anxiety

  Baseline (T0) and immediately following the 12-week intervention period (T1).

• Depression

  Baseline (T0) and immediately following the 12-week intervention period (T1).

Study Arms (3)

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.

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.

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.

Behavioral: Gamified Blended Mindfulness Program

Interventions

Psychoeducation and Free App Recommendation BEHAVIORAL

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.

Control Group

Standard Blended Mindfulness Program BEHAVIORAL

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.

Intervention Group 1

Gamified Blended Mindfulness Program BEHAVIORAL

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.

Intervention Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pre-existing clinical diagnosis of anxiety or depressive disorders.
• Current use of prescribed psychotropic medications (concurrent psychopharmacological treatment).

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Ceuta

Ceuta, Ceuta, 51005, Spain

Location

MeSH Terms

Conditions

Burnout, Psychological; Stress, Psychological; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: February 1, 2025
• Primary Completion: September 5, 2025
• Study Completion: March 1, 2026
• Last Updated: July 13, 2026

Record last verified: 2025-07

Locations

ES (1)