Women's HealthVR-SCSNCT06622408
Contribution of Virtual Reality in the Management of Patients Undergoing Scheduled Cesarean Section - VR-SCS
A study testing HypnoVR© virtual reality headset in people with Women's Health and Perinatal Care, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health, Perinatal Care, Cesarean
- What is being tested?
- HypnoVR© virtual reality headset
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2024to 22 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- HypnoVR© virtual reality headset
- Keywords
- cesarean, analgesia, women
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnoVR© virtual reality headsetOther
Adherence to the use of the virtual reality headset will be reported by a percentage of use at each stage of care.
| Study group | Role | What they receive |
|---|---|---|
| Scheduled caesarean delivery | Experimental | Use of virtual reality headset during patient admission to the OR for cesarean section. Receives: Other: HypnoVR© virtual reality headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 18 months
Secondary outcomes (16)
Assessing patients' pain throughout the treatment process
The patient's pain will be assessed according to a VAS from 0 to 100.
Measured: 18 months
Evaluate patient anxiety throughout treatment
The patient's anxiety will be assessed using a VAS from 0 to 100.
Measured: 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?
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months
Assessing the impact on newborns
The newborn's condition at birth will be assessed by pH at the cord.
Measured: 18 months
Assessing the impact on newborns
The newborn's condition at birth will be assessed by lactates at the cord (in mmol/L).
Measured: 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.
Measured: 18 months
Assessment feasibility
Completion rate of evaluation questionnaires
Measured: 18 months
Evaluation of study refusals
Refusal rate and Reason for refusal to participate (if patient wishes to justify refusal)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start25 Nov 2024
- Primary completion22 Jun 2026
- Study completion22 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's HealthStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622408
- Sponsor's protocol ID
- 23-AOIP-05
- Acronym
- VR-SCS
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Virtual Reality in the Management of Patients Undergoing Scheduled Cesarean Section - VR-SCS Study (Virtual Reality and Schedulded Cesarean Section)
- ClinicalTrials.gov ID
- NCT06622408
- Acronym / sponsor ID
- VR-SCS / 23-AOIP-05
- Conditions
- Women's Health, Perinatal Care, Cesarean, Analgesia
- Keywords
- cesarean, analgesia, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 22 Jun 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scheduled caesarean delivery | Experimental | Other: HypnoVR© virtual reality headsetUse of virtual reality headset during patient admission to the OR for cesarean section. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnoVR© virtual reality headsetAdherence to the use of the virtual reality headset will be reported by a percentage of use at each stage of care. | Other | Scheduled caesarean delivery |
Primary outcome
Evaluate the feasibility of a pathway involving the use of virtual reality from patient admission to the cesarean section.
Time frame: 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).
16 secondary outcomes
Assessing patients' pain throughout the treatment process
Time frame: 18 months
Evaluate patient anxiety throughout treatment
Time frame: 18 months
Evaluate patient satisfaction throughout the care process
Time frame: 18 months
Evaluation of the impact on the course of surgery and the post-operative period
Time frame: 18 months
Evaluation of the impact on the course of surgery and the post-operative period
Time frame: 18 months
Evaluation of the impact on the course of surgery and the post-operative period
Time frame: 18 months
Evaluation of the impact on the course of surgery and the post-operative period
Time frame: 18 months
Evaluation of the impact on the course of surgery and the post-operative period
Time frame: 18 months
Assessing the impact on newborns by APGAR
Time frame: 18 months
Assessing the impact on newborns by APGAR
Time frame: 18 months
Assessing the impact on newborns by APGAR
Time frame: 18 months
Assessing the impact on newborns
Time frame: 18 months
Assessing the impact on newborns
Time frame: 18 months
Evaluation of the medical team's satisfaction after surgery
Time frame: 18 months
Assessment feasibility
Time frame: 18 months
Evaluation of study refusals
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HypnoVR© virtual reality headset in people with Women's Health and Perinatal Care, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the feasibility of a pathway involving the use of virtual reality from patient admission to the cesarean section. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.