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

Contribution of Virtual Reality in the Management of Patients Undergoing Scheduled Cesarean Section - VR-SCS Study (Virtual Reality and Schedulded Cesarean Section)

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Cesarean; Women's Health; Perinatal Care
• Intervention / Treatment: Other: HypnoVR© virtual reality headset

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06200
      • CHU Nice - Hôpital de l'Archet 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scheduled caesarean delivery; Use of virtual reality headset during patient admission to the OR for cesarean section.	Other: HypnoVR© virtual reality headset; Adherence to the use of the virtual reality headset will be reported by a percentage of use at each stage of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing patients' pain throughout the treatment process	The patient's pain will be assessed according to a VAS from 0 to 100.	18 months
Evaluate patient anxiety throughout treatment	The patient's anxiety will be assessed using a VAS from 0 to 100.	18 months
Evaluate patient satisfaction throughout the care process	Patient satisfaction will be assessed according to 2 closed questions: "Would you recommend this service to someone close to you? "If you were to have another caesarean section, would you want this care again?	18 months
Evaluation of the impact on the course of surgery and the post-operative period	The impact on the course of surgery and the post-operative period will be assessed by Total operative time (in minutes).	18 months
Evaluation of the impact on the course of surgery and the post-operative period	The impact on the course of surgery and the post-operative period will be assessed by Amount of blood loss (in mL).	18 months
Evaluation of the impact on the course of surgery and the post-operative period	The impact on the course of surgery and the post-operative period will be assessed by the occurrence of nausea/vomiting during the operation.	18 months
Evaluation of the impact on the course of surgery and the post-operative period	The impact on the course of surgery and the post-operative period will be assessed by the time between the end of the caesarean section and the patient's first rising (in hours).	18 months
Evaluation of the impact on the course of surgery and the post-operative period	The impact on the course of surgery and the post-operative period will be assessed by Time from end of caesarean section to first micturition (in hours).	18 months
Assessing the impact on newborns by APGAR	The newborn's condition at birth will be assessed by APGAR at 1 minute of life.	18 months
Assessing the impact on newborns by APGAR	The newborn's condition at birth will be assessed by APGAR at 5 minutes of life.	18 months
Assessing the impact on newborns by APGAR	The newborn's condition at birth will be assessed by APGAR at 10 minutes of life.	18 months
Assessing the impact on newborns	The newborn's condition at birth will be assessed by pH at the cord.	18 months
Assessing the impact on newborns	The newborn's condition at birth will be assessed by lactates at the cord (in mmol/L).	18 months
Evaluation of the medical team's satisfaction after surgery	The surgeon's satisfaction based on a VAS from 0 to 100 at the end of the procedure and the anesthetist's satisfaction based on a VAS from 0 to 100 at the end of the procedure.	18 months
Assessment feasibility	Completion rate of evaluation questionnaires	18 months
Evaluation of study refusals	Refusal rate and Reason for refusal to participate (if patient wishes to justify refusal)	18 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Actual): June 22, 2026
• Study Completion (Actual): June 22, 2026

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: analgesia; women; cesarean
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: 23-AOIP-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No