Immersive Virtual Reality for the Management of Anxiety Among Nurses (RVI-Nurse)

April 1, 2026 updated by: SCP Anesthésie - Réanimation de la Clinique du Pont de Chaume

Use of Immersive Virtual Reality for the Management of Anxiety Among Nurses : a Randomized Trial

The nursing profession is recognized as one of the most demanding in the healthcare sector. Constant exposure to illness, suffering, and death, combined with an increasing workload, leads to fatigue, stress, and especially persistent anxiety. This anxiety affects not only the psychological and physical health of nurses but also the quality of care provided. From an organizational perspective, anxiety promotes absenteeism, demotivation, and turnover, creating a vicious cycle of collective exhaustion.

To relieve their anxiety, an increasing number of healthcare providers are turning to complementary medicine, particularly immersive virtual reality (VR) interventions.

Immersive VR hypnosis has been used for several years as a non-pharmacological approach to anxiety management. It constitutes a relational experience engaging both physiological and psychological mechanisms, allowing the user to improve their experience and reduce or even eliminate anxiety.

Randomized clinical trials conducted in recent years have evaluated the efficacy of immersive VR hypnosis. Some results indicate that it reduces anxiety more significantly than pharmacological treatments in control groups and is at least as effective as other complementary therapies (relaxation, massage, acupuncture, yoga, etc.). However, the strength of these conclusions remains limited due to a substantial risk of methodological bias. Rigorous new studies, with strict control conditions, are required, particularly regarding the efficacy of hypnosis applied to nurses.

Since 2024, the investigators have offered hypnotic VR sessions to nurses at the Clinique du Pont de Chaume to better manage their anxiety. Despite the high satisfaction rate reported in our questionnaires, the investigators now aim to statistically evaluate the efficacy of this intervention. Ultimately, these results could justify a broader investment in this type of equipment, making it available to a larger number of healthcare professionals but only if this complementary intervention demonstrates scientific efficacy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Research Hypothesis The hypothesis of this study is that hypnotic immersive virtual reality (VR) interventions can reduce nurses' anxiety.

Benefit/Risk Assessment The use of hypnotic immersive VR techniques presents no risk to nurses. This approach is complementary to existing protocols, notably by providing immersive VR headsets during rest periods.

________________________________________ Research Objectives Primary Objective To evaluate the efficacy of hypnotic immersive VR in reducing anxiety among day-shift nurses before and after a coffee break.

Secondary Objective To assess the effect of hypnotic immersive VR on nurses' satisfaction following the coffee break.

Study Design This is a pilot, open-label, randomized controlled trial (RCT), conducted intention-to-treat, single-center, aiming to evaluate the efficacy of hypnotic immersive virtual reality (VR) interventions on day-shift nurses' anxiety after a coffee break.

The protocol is initially limited to day-shift nurses for organizational reasons and to maintain group homogeneity. Night-shift nurses are exposed to different constraints: smaller staff, altered circadian rhythm, limited number of physicians, etc.

The secondary objective of this study is to assess the impact of this intervention on nurses' satisfaction.

________________________________________ Study Endpoints Primary Endpoint The primary endpoint is the change in the Spielberger anxiety score, measured between the beginning and the end of the coffee break.

Secondary Endpoint The secondary endpoint is the nurses' satisfaction, measured using a Likert scale.

________________________________________ Study Timeline Start of recruitment: Upon obtaining all regulatory approvals. Recruitment period: 24 months. Duration of participation per nurse: 1 day (maximum delay between inclusion and data collection).

Total study duration: 27 months. Pre-Inclusion and Inclusion Visits Pre-inclusion visit: Conducted by Dr. PEREIRA DE SOUZA NETO 2 weeks to 1 month before data collection. During this visit, the nurse is informed about the protocol, its objectives, constraints, potential risks (nausea, vomiting), and expected benefits. A copy of the information sheet and consent form is provided for reflection.

Inclusion visit: Conducted by Dr. PEREIRA DE SOUZA on the day of data collection. The nurse provides written informed consent. Both the nurse and investigator sign and date the consent form. Copies are distributed as follows:

One copy is given to the nurse. The original is kept by Dr. PEREIRA DE SOUZA in a secure location inaccessible to third parties, even in case of staff reassignments during the study.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Nurses who have received appropriate information, agreed to participate, and signed the informed consent form.

Nurses working day shifts (06:00-18:00) with a coffee break scheduled from 09:00 to 09:15.

Exclusion Criteria:

Nurses who have not provided informed consent or cannot comply with the study protocol.

History of photosensitive epilepsy or seizures. Unstable vestibular disorders or a severe history of motion sickness preventing the use of immersive VR.

Employer refusal if participation cannot be organized outside work obligations (participation must remain voluntary and without professional consequences).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hypnotic Immersive Virtual Reality Group
  • On the day of the study, upon arrival in the coffee break room, nurses complete the Spielberger self-assessment anxiety questionnaire.
  • The anesthesiologist responsible for the protocol (Dr. PEREIRA DE SOUZA) ensures that the nurse has understood the study protocol and answers any questions.
  • The nurse then begins the hypnotic immersive VR session in a calm, dedicated room.
  • At the end of the session, before returning to work, the nurse completes the Spielberger questionnaire again, along with a Likert scale to evaluate satisfaction. Any potential adverse effects (nausea, vomiting, etc.) are also recorded.
Other: virtual reality
Since 2024, the investigators have offered hypnotic VR sessions to nurses at the Clinique du Pont de Chaume to better manage their anxiety. Despite the high satisfaction rate reported in our questionnaires, the investigators now aim to statistically evaluate the efficacy of this intervention. Ultimately, these results could justify a broader investment in this type of equipment, making it available to a larger number of healthcare professionals (orderlies, nursing assistants, secretaries, pharmacists, physicians, etc.), but only if this complementary intervention demonstrates scientific efficacy.
No Intervention: Control Group
  • On the day of the study, upon arrival in the coffee break room, nurses complete the Spielberger questionnaire.
  • The anesthesiologist (Dr. PEREIRA DE SOUZA) ensures understanding of the protocol and answers questions.
  • The nurse then takes their coffee break normally with their team.
  • At the end of the coffee break, before returning to work, the nurse completes the Spielberger questionnaire again, along with the Likert scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Spielberger questionnaire measurement
Time Frame: From enrollement to the end of study at 1 day
To evaluate the efficacy of hypnotic immersive VR in changing anxiety among day-shift nurses before and after a coffee break. Anxiety will be measured with the Spielberger anxiety score, measured between the beginning and the end of hypnotic immersive VR or between the beginning and the end of the coffee break or
From enrollement to the end of study at 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary endpoint is the nurses' satisfaction, measured using a Likert scale.
Time Frame: From enrollement to the end of study at 1 day

At the end of the session, before returning to work, the nurse completes the Likert scale to evaluate satisfaction.

Would you say that the experience with Immersive Virtual Reality had a positive or negative impact?

Very positive

Somewhat positive

Neither positive nor negative

Somewhat negative

Very negative

Any potential adverse effects (nausea, vomiting, etc.) are also recorded.
From enrollement to the end of study at 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCP Anesthésie - Réanimation de la Clinique du Pont de Chaume

Investigators

  • Principal Investigator: Edmundo P PEREIRA DE SOUZA NETO, Phd, Clinique du Pont de Chaume - Montauban

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

December 6, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVI-Nurse

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data collection is performed by Dr. PEREIRA DE SOUZA NETO, and data management by a Data Manager of the Clinical Research and Innovation Department of Clinique du Pont de Chaume.

Any transfer of all or part of the study database is decided by the sponsor and formalized in a written agreement.

IPD Sharing Time Frame

At the end of the study

IPD Sharing Access Criteria

All information required by the protocol must be recorded in the electronic patient record.

Study Monitoring

  • Logistics and monitoring:

    • Managed by the Clinical Research Associate (CRA) in collaboration with the principal investigator.
    • Includes organizing inclusions, participant follow-up, and protocol compliance control.

  • Progress reports:

    • The CRA prepares and submits regular progress reports to the sponsor.
    • Reports include recruitment, adverse events, and collected data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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