CHU de Liège
Liège, 4000, Belgium
NCT Number: NCT05558449
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Liège, 4000, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 intravenous injection 1 mg until RASS -3
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.
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.
Time frame: 5 minutes after the end of the surgery
Numeric rating scale (NRS) (0 to 10) for pre- and postoperative anxiety
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
Time frame: 5 minutes after the end of the surgery
Length of surgery procedure in minutes
Time frame: 6 hours after surgery
The occurrence of complications related to the techniques used
Time frame: 6 hours after surgery
The occurrence of side effects related to virtual reality (nausea, paradoxical anxiety, dizziness, etc.)
Time frame: 5 minutes after the end of the surgery
Perception of the duration of the surgery during the VRH.
Time frame: 5 minutes after the end of the surgery
Surgeon satisfaction on a numeric rating scale from 0 to 10
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
University of Liege
Other
Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia: a Randomized Clinical Trial.
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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