Analgesia, Foot Deformities, Regional Anesthesia Morbidity, Valgus; Hallux
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHypnosedation
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.
DRUGMidazolam injection
Midazolam intravenous injection 1 mg until RASS -3
DEVICEVirtual reality
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.
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open
Intervention model description
Prospective Randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (Evaluation du Vecu de l'Anesthesie LocoRegionale) EVAN-LR | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery- 15 items (QoR-15) | 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 |
| Length of surgery | 5 minutes after the end of the surgery | Length of surgery procedure in minutes |
| Complications | 6 hours after surgery | The occurrence of complications related to the techniques used |
| Anxiety | 5 minutes after the end of the surgery | Numeric rating scale (NRS) (0 to 10) for pre- and postoperative anxiety |
| Time perception | 5 minutes after the end of the surgery | Perception of the duration of the surgery during the VRH. |
| Surgeon satisfaction | 5 minutes after the end of the surgery | Surgeon satisfaction on a numeric rating scale from 0 to 10 |
| Dissociation | 5 minutes after the end of the surgery | The Numeric rating scale (NRS) (0-10) dissociation for the assessment of dissociation during the surgery |
| VRH complications | 6 hours after surgery | The occurrence of side effects related to virtual reality (nausea, paradoxical anxiety, dizziness, etc.) |
Countries
Belgium
Outcome results
None listed