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Completed

NCT Number: NCT05558449

Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia

This prospective study aims to evaluate whether the implementation of a virtual reality hypnosedation (VRH)protocol reduces preoperative anxiety and increases patient comfort before, during, and after outpatient foot surgery.

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Key information

About this study

This prospective study aims to evaluate whether the implementation of a virtual reality hypnosedation (VRH) protocol reduces preoperative anxiety and increases patient comfort before, during, and after outpatient foot surgery. The investigators hope to demonstrate a reduction in anxiety, improved postoperative experience and functional recovery according to currently validated scores measuring preoperative and postoperative recovery, anxiety and stress, and experience during a regional anesthesia technique.

The investigators expect that VRH will be more effective than VR alone and conventional pharmacological sedation in reducing preoperative anxiety and in improving experience and functional recovery. If the hypothesis is correct, the investigators could propose to integrate this protocol as a first line in the ambulatory management of elective foot surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Major patients, classified as ASA 1-2-3, admitted for foot surgery (metatarsophalangeal arthrodesis or hallux valgus cure), under peripheral locoregional anesthesia (sciatic nerve block at popliteal level).

Exclusion criteria

  • pregnant women
  • patients with peripheral neuropathy or other severe neurological pathology
  • allergy or contraindication to local anesthetics or benzodiazepines
  • chronic renal failure or severe hepatic failure
  • major hemostasis disorders
  • severe vision or hearing problems that would render the VR and VRH device useless or unusable, and patient contraindication or refusal to use the VRH headset, such as claustrophobia or kinesiophobia.

Treatment and study plan

Hypnosedation

Device

Hypnosedation session with a virtual reality headset during the regional anesthesia technique and during the surgery (approximately 60 minutes). The VRH module used will be "Silva", i.e. the same scenario of a walk in the forest through the 4 seasons with a voice accompanying the hypnosis session.

Midazolam injection

Drug

Midazolam intravenous injection 1 mg until RASS -3

Virtual reality

Device

Only virtual reality without a hypnosedation session. The virtual reality headset will be used on these patients without external voice or hypnosis device. The virtual reality module used will be "Silva", i.e. a scenario of a walk in the forest through the 4 seasons.

Primary outcomes

  1. (Evaluation du Vecu de l'Anesthesie LocoRegionale) EVAN-LR

    Time frame: 4 hours after surgery

    The primary endpoint will be the EVAN-LR score as a measure of intraoperative experience. EVAN-LR: a 0-100 scale, with 100 indicating the best possible level of satisfaction and 0 the worst.

Secondary outcomes

  1. Anxiety

    Time frame: 5 minutes after the end of the surgery

    Numeric rating scale (NRS) (0 to 10) for pre- and postoperative anxiety

  2. Quality of Recovery- 15 items (QoR-15)

    Time frame: 1 day before, 1 and 3 day after surgery

    Assessment of the QoR-15 score on postoperative functional recovery and the variation in time between the day before surgery, the day after and 3 days after surgery

  3. Length of surgery

    Time frame: 5 minutes after the end of the surgery

    Length of surgery procedure in minutes

  4. Complications

    Time frame: 6 hours after surgery

    The occurrence of complications related to the techniques used

  5. VRH complications

    Time frame: 6 hours after surgery

    The occurrence of side effects related to virtual reality (nausea, paradoxical anxiety, dizziness, etc.)

  6. Time perception

    Time frame: 5 minutes after the end of the surgery

    Perception of the duration of the surgery during the VRH.

  7. Surgeon satisfaction

    Time frame: 5 minutes after the end of the surgery

    Surgeon satisfaction on a numeric rating scale from 0 to 10

  8. Dissociation

    Time frame: 5 minutes after the end of the surgery

    The Numeric rating scale (NRS) (0-10) dissociation for the assessment of dissociation during the surgery

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia: a Randomized Clinical Trial.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2022
Registry last updated
Mar 6, 2024

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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