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

Primary Purpose

Foot Deformities, Regional Anesthesia Morbidity, Valgus; Hallux

Status
Recruiting
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Hypnosedation
Midazolam injection
Virtual reality
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Deformities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de LiègeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

VR

VRH

C

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

(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.

Secondary Outcome Measures

Anxiety
Numeric rating scale (NRS) (0 to 10) for pre- and postoperative anxiety
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
Length of surgery
Length of surgery procedure in minutes
Complications
The occurrence of complications related to the techniques used
VRH complications
The occurrence of side effects related to virtual reality (nausea, paradoxical anxiety, dizziness, etc.)
Time perception
Perception of the duration of the surgery during the VRH.
Surgeon satisfaction
Surgeon satisfaction on a numeric rating scale from 0 to 10
Dissociation
The Numeric rating scale (NRS) (0-10) dissociation for the assessment of dissociation during the surgery

Full Information

First Posted
September 22, 2022
Last Updated
December 14, 2022
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT05558449
Brief Title
Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia
Official Title
Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia: a Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Deformities, Regional Anesthesia Morbidity, Valgus; Hallux, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized Clinical Trial
Masking
None (Open Label)
Masking Description
Open
Allocation
Randomized
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR
Arm Type
Active Comparator
Arm Description
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.
Arm Title
VRH
Arm Type
Experimental
Arm Description
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.
Arm Title
C
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hypnosedation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Midazolam injection
Intervention Description
Midazolam intravenous injection 1 mg until RASS -3
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
(Evaluation du Vecu de l'Anesthesie LocoRegionale) EVAN-LR
Description
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
Secondary Outcome Measure Information:
Title
Anxiety
Description
Numeric rating scale (NRS) (0 to 10) for pre- and postoperative anxiety
Time Frame
5 minutes after the end of the surgery
Title
Quality of Recovery- 15 items (QoR-15)
Description
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
Title
Length of surgery
Description
Length of surgery procedure in minutes
Time Frame
5 minutes after the end of the surgery
Title
Complications
Description
The occurrence of complications related to the techniques used
Time Frame
6 hours after surgery
Title
VRH complications
Description
The occurrence of side effects related to virtual reality (nausea, paradoxical anxiety, dizziness, etc.)
Time Frame
6 hours after surgery
Title
Time perception
Description
Perception of the duration of the surgery during the VRH.
Time Frame
5 minutes after the end of the surgery
Title
Surgeon satisfaction
Description
Surgeon satisfaction on a numeric rating scale from 0 to 10
Time Frame
5 minutes after the end of the surgery
Title
Dissociation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Carella, MD
Phone
003242843658
Email
mcarella@chuliege.be
Email
mcarella@chuliege.be

12. IPD Sharing Statement

Plan to Share IPD
No

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

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