Contribution of Virtual Reality in the Management of Patients Undergoing Scheduled Cesarean Section - VR-SCS

Centre Hospitalier Universitaire de Nice

Status: Enrolling

Conditions: Perinatal Care; Women's Health; Cesarean; Analgesia

Treatments: Other: HypnoVR© virtual reality headset

Study type: Interventional

Funder types: Other

Identifiers

NCT06622408

23-AOIP-05

Details and patient eligibility

About

Cesarean deliveries account for 20.7% of all deliveries in France, according to the latest perinatal survey. At Nice University Hospital, the C-section rate over the last 5 years is around 19%.

Caesarean section patients are at greater risk of developing symptoms of anxiety, stress and depression. The post-operative period is also more painful, and there is a positive correlation between immediate post-operative pain and the risk of developing chronic pelvic pain. Numerous attempts to reduce these symptoms have been evaluated, including music therapy, relaxation techniques, acupressure and the use of preoperative melatonin.

Virtual reality has demonstrated its effectiveness in reducing pain and anxiety in other disciplines, notably pediatric surgery and neurosurgery.

In particular, several trials have demonstrated a reduction in anxiety in the paediatric population and, for pelvic procedures under local anaesthetic, during prostate biopsies or hysteroscopy in consultation, with a reduction in anxiety and pain respectively.

It has been used to provide information by showing a film about the caesarean section procedure, and has been shown to be effective in terms of patient satisfaction, but without being able to demonstrate a significant reduction in anxiety (p=0.06).

The use of virtual reality during the entire peri- and intra-operative management process (maternity stay, patient transfer to the operating room, locoregional anesthesia procedure and during the operation) has not been studied in the context of cesarean section.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Major woman ;
• Female volunteer ;
• Social security affiliation;
• Admitted for scheduled caesarean section with history of caesarean section and patient's refusal to attempt vaginal delivery;
• Informed patients who have signed the informed consent form.

Exclusion criteria

• Speaks a language other than French;
• Unbalanced epilepsy;
• People unable to understand (language barrier, cognitive difficulties, cerebral palsy, etc.) and/or apply dietary advice (people institutionalized in nursing homes, retirement homes, prisons, etc.);
• Women claiming to have had a very bad experience during their previous caesarean section.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Scheduled caesarean delivery

Experimental group

Description:

Use of virtual reality headset during patient admission to the OR for cesarean section.

Treatment:

Other: HypnoVR© virtual reality headset