NCT07649733

Brief Summary

Projecte Benestar 2026 is a multicenter randomized controlled study evaluating a brief immersive educational program delivered through virtual reality for healthcare workers. The program is designed to support emotional well-being, self-care, mindfulness, and emotional regulation in professionals working in healthcare settings. Participants will be active healthcare or healthcare-support workers from participating centers. They will be randomly assigned to one of two groups. One group will receive the virtual reality program at the beginning of the study, while the other group will continue usual activity and receive the same program later, after a wait-list period. The main objective is to evaluate whether the program reduces emotional exhaustion, measured with the Maslach Burnout Inventory. Secondary objectives include evaluating changes in depersonalization, personal accomplishment, work engagement, usability, satisfaction, adherence, and tolerability of the virtual reality program.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Jun 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

June 5, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

June 5, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

Virtual RealityMindfulnessHealthcare workersBurnout

Outcome Measures

Primary Outcomes (1)

  • Change in Emotional Exhaustion Score on the Maslach Burnout Inventory-Human Services Survey

    Emotional exhaustion will be assessed using the Emotional Exhaustion subscale of the Maslach Burnout Inventory-Human Services Survey. The subscale includes 9 items scored from 0 to 6, with total scores ranging from 0 to 54. Higher scores indicate greater emotional exhaustion. Changes will be compared between the immediate intervention group and the wait-list control group during the first intervention period, and will also be assessed after the delayed intervention group completes the program.

    Baseline, approximately 4 to 8 weeks, and approximately 7 months

Secondary Outcomes (8)

  • Change in Depersonalization Score on the Maslach Burnout Inventory-Human Services Survey

    Baseline, approximately 4 to 8 weeks, and approximately 7 months

  • Change in Personal Accomplishment Score on the Maslach Burnout Inventory-Human Services Survey

    Baseline, approximately 4 to 8 weeks, and approximately 7 months

  • Change in Vigor Score on the Utrecht Work Engagement Scale-9

    Baseline, approximately 4 to 8 weeks, and approximately 7 months

  • Change in Dedication Score on the Utrecht Work Engagement Scale-9

    Baseline, approximately 4 to 8 weeks, and approximately 7 months

  • Change in Absorption Score on the Utrecht Work Engagement Scale-9

    Baseline, approximately 4 to 8 weeks, and approximately 7 months

  • +3 more secondary outcomes

Other Outcomes (2)

  • Tolerability of the Virtual Reality Program

    Immediately after Sessions 1 through 8 and at intervention completion, up to 8 weeks

  • Incidence of Virtual Reality-Related Adverse Events or Session Interruptions

    From intervention start to intervention completion, approximately 4 to 8 weeks

Study Arms (2)

Immediate Intervention: Projecte Benestar VR Program

EXPERIMENTAL

Participants randomized to this arm will receive the Projecte Benestar virtual reality educational program during the first intervention period. The program includes 8 individual immersive sessions focused on mindfulness, breathing, body scan, emotional regulation, RAIN, self-compassion, and integration. Sessions last approximately 9 to 15 minutes and may be delivered over 8 weeks or 4 weeks depending on center logistics.

Behavioral: Projecte Benestar Virtual Reality Educational Program

Wait-list Control: Delayed Projecte Benestar VR Program

OTHER

Participants randomized to this arm will continue usual activity during the initial wait-list control period. After approximately 6 months, they will receive the same Projecte Benestar virtual reality educational program, consisting of 8 individual immersive sessions focused on mindfulness, breathing, body scan, emotional regulation, RAIN, self-compassion, and integration.

Behavioral: Projecte Benestar Virtual Reality Educational Program

Interventions

Projecte Benestar is an immersive educational virtual reality program focused on mindfulness, emotional regulation, and self-compassion for workers in healthcare settings. The program includes 8 individual sessions delivered through autonomous virtual reality headsets. Each session lasts approximately 9 to 15 minutes and includes guided audio and immersive 3D content. Sessions may be delivered over 8 weeks or in an intensive 4-week format, depending on local logistics.

Immediate Intervention: Projecte Benestar VR ProgramWait-list Control: Delayed Projecte Benestar VR Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active permanent or temporary staff member at a participating healthcare center where the program is implemented
  • Age 18 years or older
  • Able to understand, accept, and sign the informed consent form
  • Willing to complete the study procedures, attend the planned weekly sessions, and complete the study questionnaires

You may not qualify if:

  • Photosensitive epilepsy or history of seizures triggered by visual stimuli
  • Severe motion sickness or previous intolerance to immersive devices
  • Visual or hearing impairment that prevents adequate use of the virtual reality headset

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Badalona Serveis Assistencials

Badalona, Barcelona, 08911, Spain

RECRUITING

ABS Valls Urbà | Gerència d'Atenció Primària i a la Comunitat

Valls, Tarragona, 43800, Spain

RECRUITING

Related Publications (3)

  • Maslach C, Jackson SE, Leiter MP. Maslach Burnout Inventory Manual. 4th ed. Mind Garden; 2018.

    BACKGROUND
  • Dominguez-Salas S, Rodriguez-Dominguez C, Arcos-Romero AI, Allande-Cusso R, Garcia-Iglesias JJ, Gomez-Salgado J. Psychometric Properties of the Utrecht Work Engagement Scale (UWES-9) in a Sample of Active Health Care Professionals in Spain. Psychol Res Behav Manag. 2022 Nov 30;15:3461-3472. doi: 10.2147/PRBM.S387242. eCollection 2022.

    PMID: 36474956BACKGROUND
  • Ferrer Costa J, Moran N, Garcia Marti C, Colmenares Hernandez LJ, Radu Ciorba Ciorba F, Ciudad MJ. Immediate Impact of an 8-Week Virtual Reality Educational Program on Burnout and Work Engagement Among Health Care Professionals: Pre-Post Pilot Study. JMIR XR Spat Comput. 2024 Apr 25;1:e55678. doi: 10.2196/55678. eCollection 2024.

    PMID: 41341876BACKGROUND

MeSH Terms

Conditions

Burnout, PsychologicalOccupational Stress

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorOccupational Diseases

Study Officials

  • Jose Ferrer Costa, MD, MSc

    Badalona Serveis Assistencials - Universitat Oberta de Catalunya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

José Ferrer Costa, MD, MSc

CONTACT

Rosa García Sierra, RN, PhD, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and local study staff cannot be masked because of the nature of the virtual reality intervention. Outcome data will be collected using standardized self-administered questionnaires. The outcomes assessor/statistician responsible for scoring and analyzing the primary and secondary questionnaire outcomes will be masked to group allocation until the primary analysis is completed.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Multicenter randomized controlled trial with a delayed-start wait-list control design. Participants are randomized 1:1 by center to immediate intervention or delayed intervention. Group A receives the virtual reality program first, while Group B continues usual activity as a wait-list control. After the first intervention period and wait-list period, Group B receives the same intervention, while Group A remains in follow-up and may serve as a post-intervention comparison group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Family Physician, Coordinating Investigator

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 16, 2026

Study Start

June 8, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in future publications may be shared upon reasonable request to the corresponding author. Data will not be publicly available in an open repository. Access will be subject to approval by the study investigators, institutional data protection requirements, and, where required, a data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the main study results and for 5 years thereafter.
Access Criteria
De-identified individual participant data underlying the published results may be shared upon reasonable request to the corresponding author. Access will be limited to researchers who provide a methodologically sound proposal for approved research purposes. Requests will be reviewed by the study investigators and, where required, by the participating institutions. Data will not be made publicly available in an open repository. Access will be subject to applicable data protection requirements and, if required, a data sharing agreement.

Locations