University of Liege
Michele Carella
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.
Foot Deformities
Regional Anesthesia Morbidity
Valgus; Hallux
Analgesia
Hypnosedation
Midazolam injection
Virtual reality
Phase 4
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.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 57 participants |
| Masking : | None (Open Label) |
| Masking Description : | Open |
| Primary Purpose : | Treatment |
| Official Title : | Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia: a Randomized Clinical Trial. |
| Actual Study Start Date : | November 28, 2022 |
| Estimated Primary Completion Date : | October 16, 2023 |
| Estimated Study Completion Date : | October 16, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: VR 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 |
|
Experimental: TOP 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 |
|
Active Comparator: C 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 |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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Not yet recruiting
CHU de Liège
Liège, Belgium, 4000