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

NCT06622408 | Recruiting

• 1 other identifier: 23-AOIP-05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Women's Health; Perinatal Care; Cesarean; Analgesia

Keywords

cesarean; analgesia; women

Outcome Measures

Primary Outcomes (1)

• Evaluate the feasibility of a pathway involving the use of virtual reality from patient admission to the cesarean section.

  Rate of acceptance of the use of the virtual reality headset during each stage of care (on admission to the maternity ward, in the delivery room before transfer to the operating room, at the patient's request in the caesarean section room after birth (in the absence of skin-to-skin contact with the newborn).

  18 months

Secondary Outcomes (16)

• Assessing patients' pain throughout the treatment process

  18 months

• Evaluate patient anxiety throughout treatment

  18 months

• Evaluate patient satisfaction throughout the care process

  18 months

• Evaluation of the impact on the course of surgery and the post-operative period

  18 months

• Evaluation of the impact on the course of surgery and the post-operative period

  18 months

Study Arms (1)

Scheduled caesarean delivery

EXPERIMENTAL

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

Other: HypnoVR© virtual reality headset

Interventions

HypnoVR© virtual reality headset OTHER

Adherence to the use of the virtual reality headset will be reported by a percentage of use at each stage of care.

Scheduled caesarean delivery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes-Maritimes, 06200, France

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pierre-Alexis Dr GAUCI, MD

CONTACT

04 92 03 61 08; gauci.pa@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: October 2, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FR (1)