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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR | Active Comparator | 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. |
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| VRH | Experimental | 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. |
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| C | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| (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. | 4 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Numeric rating scale (NRS) (0 to 10) for pre- and postoperative anxiety | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Liège | Liège | 4000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40545295 | Derived | Carella M, Bicego A, Beck F, Malta C, Ardizzone L, Bonhomme VL, Vanhaudenhuyse A. Influence of virtual reality with or without hypnosis on patient-related experience and functional recovery in outpatient foot surgery with regional anesthesia: a randomized controlled trial. Reg Anesth Pain Med. 2025 Jun 22:rapm-2025-106678. doi: 10.1136/rapm-2025-106678. Online ahead of print. |
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Prospective Randomized Clinical Trial
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Open
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| Midazolam injection | Drug | Midazolam intravenous injection 1 mg until RASS -3 |
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| 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. |
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| 1 day before, 1 and 3 day after surgery |
| Length of surgery | Length of surgery procedure in minutes | 5 minutes after the end of the surgery |
| Complications | The occurrence of complications related to the techniques used | 6 hours after surgery |
| VRH complications | The occurrence of side effects related to virtual reality (nausea, paradoxical anxiety, dizziness, etc.) | 6 hours after surgery |
| Time perception | Perception of the duration of the surgery during the VRH. | 5 minutes after the end of the surgery |
| Surgeon satisfaction | Surgeon satisfaction on a numeric rating scale from 0 to 10 | 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 | 5 minutes after the end of the surgery |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D006215 | Hallux Valgus |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006991 | Hypnosis, Anesthetic |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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