- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07649733
Projecte Benestar 2026: Virtual Reality Program for Healthcare Workers (BENESTAR)
Projecte Benestar 2026: Multicenter Study of the Effectiveness and Implementability of an Immersive Educational Program for Workers in Healthcare Settings
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is a multicenter randomized controlled trial with a delayed-start wait-list control design. The study will evaluate Projecte Benestar, an immersive educational virtual reality program designed to support emotional well-being, self-care, mindfulness, emotional regulation, and self-compassion among workers in healthcare settings.
The study population will include active professionals working in participating healthcare organizations, including clinical and non-clinical staff with direct healthcare contact or support functions. Participating institutions may include primary care, hospital, and intermediate care settings. Recruitment will be conducted among eligible workers who voluntarily agree to participate and provide informed consent.
Participants will be randomized in a 1:1 ratio, stratified by center, to one of two study groups. Group A will receive the intervention during the first weeks of the study. Group B will continue usual activity during the initial period and will receive the same intervention after a wait-list period of approximately 6 months. This delayed-start design allows comparison between immediate intervention and usual activity while ensuring that all participants are eventually offered the program.
The intervention consists of eight brief individual virtual reality sessions delivered through autonomous virtual reality headsets. Each session lasts approximately 9 to 15 minutes and combines short educational content with guided immersive practice. The contents include mindfulness, breathing exercises, body scan practices, emotional regulation strategies, the RAIN technique, self-compassion, and a final integration session. Sessions may be delivered in a standard 8-week format with one session per week, or in an intensive 4-week format with two sessions per week, depending on local logistical capacity.
The virtual reality content is fixed and non-adaptive. All participants receive the same sequence of sessions. The application does not require internet connection during use and does not collect automatic data from the device. Participants complete sessions seated in a quiet institutional space, with a local study reference person available for technical support or in case of discomfort.
The primary outcome is change in emotional exhaustion measured with the Maslach Burnout Inventory-Human Services Survey. Secondary outcomes include the other burnout dimensions of depersonalization and personal accomplishment, work engagement measured with the Utrecht Work Engagement Scale, usability measured with the System Usability Scale, participant satisfaction, adherence to the sessions, and tolerability or incidents related to virtual reality use.
Data will be collected at baseline, after the first intervention cycle, at 6 months, after the delayed intervention cycle, and at 12 months. The main analysis will compare changes in outcomes between the immediate intervention group and the wait-list control group, with additional within-group pre-post analyses and follow-up assessments over time.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: José Ferrer Costa, MD, MSc
- Telefonnummer: +34937407482
- E-Mail: jfcosta@bsa.cat
Studieren Sie die Kontaktsicherung
- Name: Rosa García Sierra, RN, PhD, MSc
- Telefonnummer: +3493 741 53 38
- E-Mail: rgarciasi.mn.ics@gencat.cat
Studienorte
-
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Barcelona
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Badalona, Barcelona, Spanien, 08911
- Rekrutierung
- Badalona Serveis Assistencials
-
Kontakt:
- Jose Ferrer, MD, MSc
- Telefonnummer: +34937407482
- E-Mail: jfcosta@bsa.cat
-
-
Tarragona
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Valls, Tarragona, Spanien, 43800
- Rekrutierung
- ABS Valls Urbà | Gerència d'Atenció Primària i a la Comunitat
-
Kontakt:
- Jessica Bofarull
- Telefonnummer: +34977602000
- E-Mail: jbofarull.tgn.ics@gencat.cat
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Immediate Intervention: Projecte Benestar VR Program
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.
|
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.
|
|
Sonstiges: Wait-list Control: Delayed Projecte Benestar VR Program
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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Emotional Exhaustion Score on the Maslach Burnout Inventory-Human Services Survey
Zeitfenster: Baseline, approximately 4 to 8 weeks, and approximately 7 months
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Depersonalization Score on the Maslach Burnout Inventory-Human Services Survey
Zeitfenster: Baseline, approximately 4 to 8 weeks, and approximately 7 months
|
Depersonalization will be assessed using the Depersonalization subscale of the Maslach Burnout Inventory-Human Services Survey.
The subscale includes 5 items scored from 0 to 6, with total scores ranging from 0 to 30.
Higher scores indicate greater depersonalization.
|
Baseline, approximately 4 to 8 weeks, and approximately 7 months
|
|
Change in Personal Accomplishment Score on the Maslach Burnout Inventory-Human Services Survey
Zeitfenster: Baseline, approximately 4 to 8 weeks, and approximately 7 months
|
Personal accomplishment will be assessed using the Personal Accomplishment subscale of the Maslach Burnout Inventory-Human Services Survey.
The subscale includes 8 items scored from 0 to 6, with total scores ranging from 0 to 48.
Higher scores indicate greater personal accomplishment.
|
Baseline, approximately 4 to 8 weeks, and approximately 7 months
|
|
Change in Vigor Score on the Utrecht Work Engagement Scale-9
Zeitfenster: Baseline, approximately 4 to 8 weeks, and approximately 7 months
|
Vigor will be assessed using the Vigor dimension of the Utrecht Work Engagement Scale-9.
This dimension includes 3 items scored from 0 to 6.
The dimension score will be calculated as the mean of the items, ranging from 0 to 6. Higher scores indicate greater vigor, reflecting higher energy and mental resilience at work.
|
Baseline, approximately 4 to 8 weeks, and approximately 7 months
|
|
Change in Dedication Score on the Utrecht Work Engagement Scale-9
Zeitfenster: Baseline, approximately 4 to 8 weeks, and approximately 7 months
|
Dedication will be assessed using the Dedication dimension of the Utrecht Work Engagement Scale-9.
This dimension includes 3 items scored from 0 to 6.
The dimension score will be calculated as the mean of the items, ranging from 0 to 6. Higher scores indicate greater dedication, reflecting a stronger sense of significance, enthusiasm, inspiration, pride, and challenge at work.
|
Baseline, approximately 4 to 8 weeks, and approximately 7 months
|
|
Change in Absorption Score on the Utrecht Work Engagement Scale-9
Zeitfenster: Baseline, approximately 4 to 8 weeks, and approximately 7 months
|
Absorption will be assessed using the Absorption dimension of the Utrecht Work Engagement Scale-9.
This dimension includes 3 items scored from 0 to 6.
The dimension score will be calculated as the mean of the items, ranging from 0 to 6. Higher scores indicate greater absorption, reflecting being more fully concentrated and deeply involved in work.
|
Baseline, approximately 4 to 8 weeks, and approximately 7 months
|
|
System Usability Scale Score After the Virtual Reality Program
Zeitfenster: After completion of the intervention: approximately 4 to 8 weeks for the immediate intervention group and approximately 7 months for the delayed intervention group
|
Usability will be assessed using the System Usability Scale, a 10-item questionnaire that provides a global usability score ranging from 0 to 100.
Higher scores indicate greater perceived usability of the virtual reality program.
|
After completion of the intervention: approximately 4 to 8 weeks for the immediate intervention group and approximately 7 months for the delayed intervention group
|
|
Participant Satisfaction With the Virtual Reality Program
Zeitfenster: After completion of the intervention: approximately 4 to 8 weeks for the immediate intervention group and approximately 7 months for the delayed intervention group
|
Satisfaction will be assessed using 2 ad hoc visual analog scale items scored from 0 to 10.
The items assess perceived usefulness of the intervention and willingness to recommend the experience to colleagues.
Higher scores indicate greater satisfaction.
|
After completion of the intervention: approximately 4 to 8 weeks for the immediate intervention group and approximately 7 months for the delayed intervention group
|
|
Adherence to the Virtual Reality Program
Zeitfenster: From intervention start to intervention completion, approximately 4 to 8 weeks
|
Adherence will be calculated as the percentage of completed virtual reality sessions out of the total planned sessions.
The program includes 8 planned sessions.
Higher percentages indicate greater adherence to the intervention.
|
From intervention start to intervention completion, approximately 4 to 8 weeks
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Tolerability of the Virtual Reality Program
Zeitfenster: Immediately after Sessions 1 through 8 and at intervention completion, up to 8 weeks
|
Tolerability will be assessed immediately after Sessions 1 through 8 and at intervention completion by recording symptoms related to virtual reality use, including eye fatigue, blurred vision, headache, dizziness, nausea, disorientation, anxiety, or ergonomic discomfort.
Symptoms will be rated using an ad hoc 4-point scale from none to severe.
Lower scores indicate better tolerability.
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Immediately after Sessions 1 through 8 and at intervention completion, up to 8 weeks
|
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Incidence of Virtual Reality-Related Adverse Events or Session Interruptions
Zeitfenster: From intervention start to intervention completion, approximately 4 to 8 weeks
|
Virtual reality-related incidents will be recorded after each session using a session incident log.
Events may include dizziness, cybersickness, headache, anxiety, visual discomfort, or other symptoms leading to session interruption or withdrawal.
The outcome will be summarized as the number and proportion of participants with any recorded incident.
|
From intervention start to intervention completion, approximately 4 to 8 weeks
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Jose Ferrer Costa, MD, MSc, Badalona Serveis Assistencials - Universitat Oberta de Catalunya
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Maslach C, Jackson SE, Leiter MP. Maslach Burnout Inventory Manual. 4th ed. Mind Garden; 2018.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BENESTAR-26/085-P
- 26/085-P (Andere Kennung: CEIm IDIAP Jordi Gol Approval Code)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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