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

2026年6月10日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:José Ferrer Costa, MD, MSc
  • 電話番号:+34937407482
  • メールjfcosta@bsa.cat

研究連絡先のバックアップ

研究場所

    • Barcelona
      • Badalona、Barcelona、スペイン、08911
        • 募集
        • Badalona Serveis Assistencials
        • コンタクト:
          • Jose Ferrer, MD, MSc
          • 電話番号:+34937407482
          • メールjfcosta@bsa.cat
    • Tarragona
      • Valls、Tarragona、スペイン、43800
        • 募集
        • ABS Valls Urbà | Gerència d'Atenció Primària i a la Comunitat
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
他の: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Emotional Exhaustion Score on the Maslach Burnout Inventory-Human Services Survey
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Depersonalization Score on the Maslach Burnout Inventory-Human Services Survey
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Tolerability of the Virtual Reality Program
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Jose Ferrer Costa, MD, MSc、Badalona Serveis Assistencials - Universitat Oberta de Catalunya

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月8日

一次修了 (推定)

2027年12月1日

研究の完了 (推定)

2027年12月1日

試験登録日

最初に提出

2026年6月5日

QC基準を満たした最初の提出物

2026年6月10日

最初の投稿 (実際)

2026年6月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月16日

QC基準を満たした最後の更新が送信されました

2026年6月10日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • BENESTAR-26/085-P
  • 26/085-P (その他の識別子:CEIm IDIAP Jordi Gol Approval Code)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

IPD 共有時間枠

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.

IPD 共有アクセス基準

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.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Projecte Benestar Virtual Reality Educational Programの臨床試験

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