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Completed

NCT Number: NCT06622408

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

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.

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Key information

Conditions

Women's Health Agnosia Analgesia Cesarean Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Perinatal Care Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes-Maritimes, 06200, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HypnoVR© virtual reality headset

Other

Adherence to the use of the virtual reality headset will be reported by a percentage of use at each stage of care.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Assessing patients' pain throughout the treatment process

    Time frame: 18 months

    The patient's pain will be assessed according to a VAS from 0 to 100.

  2. Evaluate patient anxiety throughout treatment

    Time frame: 18 months

    The patient's anxiety will be assessed using a VAS from 0 to 100.

  3. Evaluate patient satisfaction throughout the care process

    Time frame: 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?

  4. Evaluation of the impact on the course of surgery and the post-operative period

    Time frame: 18 months

    The impact on the course of surgery and the post-operative period will be assessed by Total operative time (in minutes).

  5. Evaluation of the impact on the course of surgery and the post-operative period

    Time frame: 18 months

    The impact on the course of surgery and the post-operative period will be assessed by Amount of blood loss (in mL).

  6. Evaluation of the impact on the course of surgery and the post-operative period

    Time frame: 18 months

    The impact on the course of surgery and the post-operative period will be assessed by the occurrence of nausea/vomiting during the operation.

  7. Evaluation of the impact on the course of surgery and the post-operative period

    Time frame: 18 months

    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).

  8. Evaluation of the impact on the course of surgery and the post-operative period

    Time frame: 18 months

    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).

  9. Assessing the impact on newborns by APGAR

    Time frame: 18 months

    The newborn's condition at birth will be assessed by APGAR at 1 minute of life.

  10. Assessing the impact on newborns by APGAR

    Time frame: 18 months

    The newborn's condition at birth will be assessed by APGAR at 5 minutes of life.

  11. Assessing the impact on newborns by APGAR

    Time frame: 18 months

    The newborn's condition at birth will be assessed by APGAR at 10 minutes of life.

  12. Assessing the impact on newborns

    Time frame: 18 months

    The newborn's condition at birth will be assessed by pH at the cord.

  13. Assessing the impact on newborns

    Time frame: 18 months

    The newborn's condition at birth will be assessed by lactates at the cord (in mmol/L).

  14. Evaluation of the medical team's satisfaction after surgery

    Time frame: 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.

  15. Assessment feasibility

    Time frame: 18 months

    Completion rate of evaluation questionnaires

  16. Evaluation of study refusals

    Time frame: 18 months

    Refusal rate and Reason for refusal to participate (if patient wishes to justify refusal)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: VR-SCS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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