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AnxietyRVI-NurseNCT07293221

Immersive Virtual Reality for the Management of Anxiety Among Nurses

A study testing virtual reality in people with Anxiety and Nurse Based Care Management, run by SCP Anesthésie - Réanimation de la Clinique du Pont de Chaume at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety, Nurse Based Care Management
What is being tested?
virtual reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteFrance
Study dates
1 Mar 2026to 1 Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Edmundo P PEREIRA DE SOUZA NETO, PhD contact

0770017259

edmundo.pereira-de-souza@hotmail.fr

Edmundo P Souza Neto, PhD contact

33+770017259

edmundo.pereira-de-souza@hotmail.fr

France1 site, 1 recruiting
  • Clinique du Pont de Chaume - Montauban

    Montauban, 82000

    Edmundo PEREIRA DE SOUZA NETO, PhD, edmundo.pereira-de-souza@hotmail.fr

    Edmundo P SOUZA NETO, PhD, 0770017259, edmundo.pereira-de-souza@hotmail.fr

    Recruiting

Other trials in France

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
virtual reality
Keywords
Anxiety
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • virtual realityOther

    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.

Study groups in NCT07293221
Study groupRoleWhat they receive
Hypnotic Immersive Virtual Reality GroupActive comparator* 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.
Receives: Other: virtual reality
Control GroupNo intervention* 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Spielberger questionnaire measurement

    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

    Measured: From enrollement to the end of study at 1 day

Secondary outcomes (1)
  1. The secondary endpoint is the nurses' satisfaction, measured using a Likert scale.

    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.

    Measured: From enrollement to the end of study at 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2025
  2. Study start1 Mar 2026
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
nurses will be randomized into two parallel, open-label groups
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07293221
Sponsor's protocol ID
RVI-Nurse
Acronym
RVI-Nurse
Status last verified
Apr 2026
First submitted
22 Sep 2025
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Williamson A. What is hypnosis and how might it work? Palliat Care. 2019 Jan 31;12:1178224219826581. doi: 10.1177/1178224219826581. eCollection 2019. No abstract available.

    PubMed 30728719
  • Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain? AORN J. 2007 Mar;85(3):589-604. doi: 10.1016/S0001-2092(07)60130-6.

    PubMed 17352896
  • Tefikow S, Barth J, Maichrowitz S, Beelmann A, Strauss B, Rosendahl J. Efficacy of hypnosis in adults undergoing surgery or medical procedures: a meta-analysis of randomized controlled trials. Clin Psychol Rev. 2013 Jul;33(5):623-36. doi: 10.1016/j.cpr.2013.03.005. Epub 2013 Mar 26.

    PubMed 23628907
  • Spielberger CD. State-Trait Anxiety Inventory for adults sampler set manual, instrument and scoring guide. Mind Garden Eds. 1983, 1-75.

  • Sharar SR, Miller W, Teeley A, Soltani M, Hoffman HG, Jensen MP, Patterson DR. Applications of virtual reality for pain management in burn-injured patients. Expert Rev Neurother. 2008 Nov;8(11):1667-74. doi: 10.1586/14737175.8.11.1667.

    PubMed 18986237
  • Pozek JJ, De Ruyter M, Khan TW. Comprehensive Acute Pain Management in the Perioperative Surgical Home. Anesthesiol Clin. 2018 Jun;36(2):295-307. doi: 10.1016/j.anclin.2018.01.007. Epub 2018 Apr 7.

    PubMed 29759289
  • Noergaard MW, Hakonsen SJ, Bjerrum M, Pedersen PU. The effectiveness of hypnotic analgesia in the management of procedural pain in minimally invasive procedures: A systematic review and meta-analysis. J Clin Nurs. 2019 Dec;28(23-24):4207-4224. doi: 10.1111/jocn.15025. Epub 2019 Sep 3.

    PubMed 31410922
  • Mavros MN, Athanasiou S, Gkegkes ID, Polyzos KA, Peppas G, Falagas ME. Do psychological variables affect early surgical recovery? PLoS One. 2011;6(5):e20306. doi: 10.1371/journal.pone.0020306. Epub 2011 May 25.

    PubMed 21633506
  • Madden K, Middleton P, Cyna AM, Matthewson M, Jones L. Hypnosis for pain management during labour and childbirth. Cochrane Database Syst Rev. 2012 Nov 14;11:CD009356. doi: 10.1002/14651858.CD009356.pub2.

    PubMed 23152275
  • Kendrick C, Sliwinski J, Yu Y, Johnson A, Fisher W, Kekecs Z, Elkins G. Hypnosis for Acute Procedural Pain: A Critical Review. Int J Clin Exp Hypn. 2016;64(1):75-115. doi: 10.1080/00207144.2015.1099405.

    PubMed 26599994
  • Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.

    PubMed 19672167
  • Flory N, Salazar GM, Lang EV. Hypnosis for acute distress management during medical procedures. Int J Clin Exp Hypn. 2007 Jul;55(3):303-17. doi: 10.1080/00207140701338670.

    PubMed 17558720
  • Fisch S, Brinkhaus B, Teut M. Hypnosis in patients with perceived stress - a systematic review. BMC Complement Altern Med. 2017 Jun 19;17(1):323. doi: 10.1186/s12906-017-1806-0.

    PubMed 28629342
  • Facco E, Casiglia E, Masiero S, Tikhonoff V, Giacomello M, Zanette G. Effects of hypnotic focused analgesia on dental pain threshold. Int J Clin Exp Hypn. 2011 Oct-Dec;59(4):454-68. doi: 10.1080/00207144.2011.594749.

    PubMed 21867380
  • Elkins GR, Barabasz AF, Council JR, Spiegel D. Advancing Research and Practice: The Revised APA Division 30 Definition of Hypnosis. Am J Clin Hypn. 2015 Apr;57(4):378-85. doi: 10.1080/00029157.2015.1011465.

    PubMed 25928776

Questions about this trial

What is this clinical trial studying?

A study testing virtual reality in people with Anxiety and Nurse Based Care Management, run by SCP Anesthésie - Réanimation de la Clinique du Pont de Chaume at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Edmundo P PEREIRA DE SOUZA NETO, PhD (0770017259, edmundo.pereira-de-souza@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Spielberger questionnaire measurement (time frame: From enrollement to the end of study at 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07293221, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

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