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

Last updated: November 29, 2024
Sponsor: Centre Hospitalier Universitaire de Nice
Overall Status: Active - Recruiting

Phase

N/A

Condition

Labor/delivery

Women's Health

Pain

Treatment

HypnoVR© virtual reality headset

Clinical Study ID

NCT06622408
23-AOIP-05
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Major woman ;

  • Female volunteer ;

  • Social security affiliation;

  • Admitted for scheduled caesarean section with history of caesarean section andpatient's refusal to attempt vaginal delivery;

  • Informed patients who have signed the informed consent form.

Exclusion

Exclusion Criteria:

  • Speaks a language other than French;

  • Unbalanced epilepsy;

  • People unable to understand (language barrier, cognitive difficulties, cerebralpalsy, 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 caesareansection.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: HypnoVR© virtual reality headset
Phase:
Study Start date:
November 25, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • CHU Nice - Hôpital de l'Archet 2

    Nice, Alpes-Maritimes 06200
    France

    Active - Recruiting

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