Contribution of Virtual Reality in the Management of Patients Undergoing Scheduled Cesarean Section - VR-SCS
NCT ID: NCT06622408
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-11-25
2026-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Scheduled caesarean delivery
Use of virtual reality headset during patient admission to the OR for cesarean section.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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CHU Nice - Hôpital de l'Archet 2
Nice, Alpes-Maritimes, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-AOIP-05
Identifier Type: -
Identifier Source: org_study_id