Analgesia, Cesarean, Perinatal Care, Women's Health
Conditions
Keywords
cesarean, analgesia, women
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.
Interventions
OTHERHypnoVR© 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.
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the feasibility of a pathway involving the use of virtual reality from patient admission to the cesarean section. | 18 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessing patients' pain throughout the treatment process | 18 months | The patient's pain will be assessed according to a VAS from 0 to 100. |
| Evaluate patient anxiety throughout treatment | 18 months | The patient's anxiety will be assessed using a VAS from 0 to 100. |
| Evaluate patient satisfaction throughout the care process | 18 months | 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? |
| Evaluation of the impact on the course of surgery and the post-operative period | 18 months | The impact on the course of surgery and the post-operative period will be assessed by Total operative time (in minutes). |
| Assessing the impact on newborns by APGAR | 18 months | The newborn's condition at birth will be assessed by APGAR at 1 minute of life. |
| Assessing the impact on newborns | 18 months | The newborn's condition at birth will be assessed by pH at the cord. |
| Evaluation of the medical team's satisfaction after surgery | 18 months | 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. |
| Assessment feasibility | 18 months | Completion rate of evaluation questionnaires |
| Evaluation of study refusals | 18 months | Refusal rate and Reason for refusal to participate (if patient wishes to justify refusal) |
Countries
France
Outcome results
None listed