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Projecte Benestar 2026: Virtual Reality Program for Healthcare Workers (BENESTAR)

10 czerwca 2026 zaktualizowane przez: Jose Ferrer Costa, Badalona Serveis Assistencials

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

100

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: José Ferrer Costa, MD, MSc
  • Numer telefonu: +34937407482
  • E-mail: jfcosta@bsa.cat

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Hiszpania
    • Barcelona
      • Badalona, Barcelona, Hiszpania, 08911
        • Rekrutacyjny
        • Badalona Serveis Assistencials
        • Kontakt:
          • Jose Ferrer, MD, MSc
          • Numer telefonu: +34937407482
          • E-mail: jfcosta@bsa.cat
    • Tarragona
      • Valls, Tarragona, Hiszpania, 43800
        • Rekrutacyjny
        • ABS Valls Urbà | Gerència d'Atenció Primària i a la Comunitat
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: Projecte Benestar Virtual Reality Educational Program
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.
Inny: 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.
Behawioralne: Projecte Benestar Virtual Reality Educational Program
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Emotional Exhaustion Score on the Maslach Burnout Inventory-Human Services Survey
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Depersonalization Score on the Maslach Burnout Inventory-Human Services Survey
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Tolerability of the Virtual Reality Program
Ramy czasowe: 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.
Immediately after Sessions 1 through 8 and at intervention completion, up to 8 weeks
Incidence of Virtual Reality-Related Adverse Events or Session Interruptions
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Badalona Serveis Assistencials

Współpracownicy

Institut Catala de Salut
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Corporació de Salut del Maresme i la Selva

Śledczy

  • Główny śledczy: Jose Ferrer Costa, MD, MSc, Badalona Serveis Assistencials - Universitat Oberta de Catalunya

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

8 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2027

Ukończenie studiów (Szacowany)

1 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

5 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

16 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • BENESTAR-26/085-P
  • 26/085-P (Inny identyfikator: CEIm IDIAP Jordi Gol Approval Code)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

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.

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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