Clinical trial NCT06622408: Contribution of Virtual Reality in the Management of Patients Undergoing Scheduled Cesarean Section - VR-SCS
Official title: Contribution of Virtual Reality in the Management of Patients Undergoing Scheduled Cesarean Section - VR-SCS Study (Virtual Reality and Schedulded Cesarean Section)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Women's Health
Perinatal Care
Cesarean
Analgesia
Keywords: cesarean
analgesia
women
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the feasibility of a pathway involving the use of virtual reality from patient admission to the cesarean section.
timeFrame: 18 months
Secondary outcomes:
measure: Assessing patients' pain throughout the treatment process
timeFrame: 18 months
measure: Evaluate patient anxiety throughout treatment
timeFrame: 18 months
measure: Evaluate patient satisfaction throughout the care process
timeFrame: 18 months
measure: Evaluation of the impact on the course of surgery and the post-operative period
timeFrame: 18 months
measure: Evaluation of the impact on the course of surgery and the post-operative period
timeFrame: 18 months
measure: Evaluation of the impact on the course of surgery and the post-operative period
timeFrame: 18 months
measure: Evaluation of the impact on the course of surgery and the post-operative period
timeFrame: 18 months
measure: Evaluation of the impact on the course of surgery and the post-operative period
timeFrame: 18 months
measure: Assessing the impact on newborns by APGAR
timeFrame: 18 months
measure: Assessing the impact on newborns by APGAR
timeFrame: 18 months
measure: Assessing the impact on newborns by APGAR
timeFrame: 18 months
measure: Assessing the impact on newborns
timeFrame: 18 months
measure: Assessing the impact on newborns
timeFrame: 18 months
measure: Evaluation of the medical team's satisfaction after surgery
timeFrame: 18 months
measure: Assessment feasibility
timeFrame: 18 months
measure: Evaluation of study refusals
timeFrame: 18 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU Nice - Hôpital de l'Archet 2
state: Alpes-Maritimes
Study officials:
References: