Foot DeformitiesPhase 4NCT05558449
Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia
A Phase 4 study testing Hypnosedation, Midazolam injection and Virtual reality in people with Foot Deformities and Regional Anesthesia Morbidity, run by University of Liege at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Deformities, Regional Anesthesia Morbidity, Valgus; Hallux
- What is being tested?
- Hypnosedation, Midazolam injection and Virtual reality
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Nov 2022to 16 Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia: a Randomized Clinical Trial.
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.
Read the 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.
- Being tested
- Hypnosedation, Midazolam injection, Virtual reality
- Medical subject headings
- Foot Deformities, Hallux Valgus, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosedationDevice
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.
Midazolam injectionDrug
Midazolam intravenous injection 1 mg until RASS -3
Virtual realityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual reality |
| 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. Receives: Device: Hypnosedation |
| 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. Receives: Drug: Midazolam injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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.
Measured: 4 hours after surgery
Secondary outcomes (8)
Anxiety
Numeric rating scale (NRS) (0 to 10) for pre- and postoperative anxiety
Measured: 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
Measured: 1 day before, 1 and 3 day after surgery
Length of surgery
Length of surgery procedure in minutes
Measured: 5 minutes after the end of the surgery
Complications
The occurrence of complications related to the techniques used
Measured: 6 hours after surgery
VRH complications
The occurrence of side effects related to virtual reality (nausea, paradoxical anxiety, dizziness, etc.)
Measured: 6 hours after surgery
Time perception
Perception of the duration of the surgery during the VRH.
Measured: 5 minutes after the end of the surgery
Surgeon satisfaction
Surgeon satisfaction on a numeric rating scale from 0 to 10
Measured: 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
Measured: 5 minutes after the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start28 Nov 2022
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foot DeformitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Carella, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558449
- Sponsor's protocol ID
- VRH.foot
- Status last verified
- Mar 2024
- First submitted
- 22 Sep 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Aug 5;51(8):931-939. doi: 10.1136/rapm-2025-106678.
PubMed 40545295
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05558449
- Acronym / sponsor ID
- VRH.foot
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| VR | Active comparator | Device: Virtual realityPatients 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. |
| VRH | Experimental | Device: HypnosedationThe 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. |
| C | Active comparator | Drug: Midazolam injectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnosedationHypnosedation 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. | Device | VRH |
| Midazolam injectionMidazolam intravenous injection 1 mg until RASS -3 | Drug | C |
| Virtual realityOnly 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. | Device | VR |
Primary outcome
(Evaluation du Vecu de l'Anesthesie LocoRegionale) EVAN-LR
Time frame: 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.
8 secondary outcomes
Anxiety
Time frame: 5 minutes after the end of the surgery
Quality of Recovery- 15 items (QoR-15)
Time frame: 1 day before, 1 and 3 day after surgery
Length of surgery
Time frame: 5 minutes after the end of the surgery
Complications
Time frame: 6 hours after surgery
VRH complications
Time frame: 6 hours after surgery
Time perception
Time frame: 5 minutes after the end of the surgery
Surgeon satisfaction
Time frame: 5 minutes after the end of the surgery
Dissociation
Time frame: 5 minutes after the end of the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 40545295Carella 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. 2026 Aug 5;51(8):931-939. doi: 10.1136/rapm-2025-106678.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hypnosedation, Midazolam injection and Virtual reality in people with Foot Deformities and Regional Anesthesia Morbidity, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Evaluation du Vecu de l'Anesthesie LocoRegionale) EVAN-LR (time frame: 4 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05558449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.