A Phase 4 interventional study of Hypnosedation and Midazolam injection in Foot Deformities, Regional Anesthesia Morbidity and Valgus; Hallux, sponsored by University of Liege. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by University of Liege · Phase 4, Interventional, and Treatment
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.
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.
50 studies on the registry are indexed under Foot Deformities; 13 are open to participants now.
This study's enrollment of 57 is close to the median of 60 across 26 interventional studies indexed under Foot Deformities.
Browse Foot Deformities studies →University of Liege is the lead sponsor of 251 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the VR group (19 patients) will receive VR alone without hypnosedation. The VR headset will be used on these patients without an external voice or device allowing hypnosis. The VR module used will be "Silva", i.e. a scenario of a walk in the forest through the 4 seasons.
Device: Virtual reality
The patients in the VRH group (19 patients) will benefit from a hypnosedation session with a VRH headset during the local 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.
Device: Hypnosedation
Patients in group C (control group, 19 patients) will receive only midazolam-based pharmacological sedation. This will be administered with intermittent boluses of 1 mg until patient comfort and sedation on the Richmond analgo-sedation scale (RASS) of -3 (response to verbal stimulus) is achieved.
Drug: Midazolam injection
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.
(Evaluation du Vecu de l'Anesthesie LocoRegionale) EVAN-LR
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: 4 hours after surgery
Anxiety
Numeric rating scale (NRS) (0 to 10) for pre- and postoperative anxiety
Time frame: 5 minutes after the end of the surgery
Quality of Recovery- 15 items (QoR-15)
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: 1 day before, 1 and 3 day after surgery
Length of surgery
Length of surgery procedure in minutes
Time frame: 5 minutes after the end of the surgery
Complications
The occurrence of complications related to the techniques used
Time frame: 6 hours after surgery
VRH complications
The occurrence of side effects related to virtual reality (nausea, paradoxical anxiety, dizziness, etc.)
Time frame: 6 hours after surgery
Time perception
Perception of the duration of the surgery during the VRH.
Time frame: 5 minutes after the end of the surgery
Surgeon satisfaction
Surgeon satisfaction on a numeric rating scale from 0 to 10
Time frame: 5 minutes after the end of the surgery
Dissociation
The Numeric rating scale (NRS) (0-10) dissociation for the assessment of dissociation during the surgery
Time frame: 5 minutes after the end of the surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2022 to primary completion in Oct 2023, 10 months.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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