Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia

Analgesia Clinical Trial

Official title:

Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia: a Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05558449
• Other study ID #: VRH.foot
• Status: Completed
• Phase: Phase 4
• Start date: November 28, 2022
• Est. completion date: October 16, 2023

Study information

• Verified date: March 2024
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 16, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Foot Deformities
• Regional Anesthesia Morbidity

Intervention

Device:
• Hypnosedation
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.

Drug:
• Midazolam injection
Midazolam intravenous injection 1 mg until RASS -3

Device:
• Virtual 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.

Locations

Country	Name	City	State
Belgium	CHU de Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(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
Secondary	Anxiety	Numeric rating scale (NRS) (0 to 10) for pre- and postoperative anxiety	5 minutes after the end of the surgery
Secondary	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	1 day before, 1 and 3 day after surgery
Secondary	Length of surgery	Length of surgery procedure in minutes	5 minutes after the end of the surgery
Secondary	Complications	The occurrence of complications related to the techniques used	6 hours after surgery
Secondary	VRH complications	The occurrence of side effects related to virtual reality (nausea, paradoxical anxiety, dizziness, etc.)	6 hours after surgery
Secondary	Time perception	Perception of the duration of the surgery during the VRH.	5 minutes after the end of the surgery
Secondary	Surgeon satisfaction	Surgeon satisfaction on a numeric rating scale from 0 to 10	5 minutes after the end of the surgery
Secondary	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