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

S

SCP Anesthésie - Réanimation de la Clinique du Pont de Chaume

Status

Not yet enrolling

Conditions

Nurse Based Care Management
Anxiety

Treatments

Other: virtual reality

Study type

Interventional

Funder types

Other

Identifiers

NCT07293221
RVI-Nurse

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

56 participants in 2 patient groups

Hypnotic Immersive Virtual Reality Group
Active Comparator group
Description:
* 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.
Treatment:
Other: virtual reality
Control Group
No Intervention group
Description:
* 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.

Trial contacts and locations

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Central trial contact

Edmundo P Souza Neto, PhD; guilherme P CACHEFO, PhD

Data sourced from clinicaltrials.gov

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