Hallux ValgusPACAH-UCA HVNCT04711278
Using Virtual Reality to Prevent Pre-operative Anxiety in Ambulatory Surgery Patients
A study testing Mask-wearing hypnosis and Without hypnosis in people with Hallux Valgus and Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective is to evaluate the impact on pre-operative anxiety management of using the virtual reality mask for surgery of hallux valgus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus, Surgery
- What is being tested?
- Mask-wearing hypnosis and Without hypnosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2021to 17 May 2022
- Phase
- Interventional
- 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
- Patient ≥ 18 years;
- Autonomous patient living at home;
- Affiliated to a social security scheme;
- Informed consent signed by patient;
- Patient will undergo a planned ambulatory surgery for hallux valgus.
Who cannot join
- Inability to understand STAI-A questionnaire;
- Patient refusal;
- Patient underwent a bilateral surgery;
- Patient judicial decision;
- Covered by french AME health system.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP
Boulogne-Billancourt, 92100
About this study
Official title: Hypnosis Mask in Pre-operative Anxiety Management in Ambulatory Surgery Patients: Using Virtual Reality
The primary objective is to evaluate the impact on pre-operative anxiety management of using the virtual reality mask for surgery of hallux valgus.
Read the detailed description
As secondary objectives, the study aims
- to evaluate post-operative analgesic according to non-drug pre-operative hypnosis, measured by reduction in analgesic intake, and by evaluate of pain;
- to evaluate factors which permitting discharge rapidly from hospital in case of hypnosis with virtual reality.
- Conditions
- Hallux Valgus, Surgery
- Being tested
- Mask-wearing hypnosis, Without hypnosis
- Keywords
- hallux valgus, hypnosis, pre-operative anxiety, surgery
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mask-wearing hypnosisDevice
Virtual mask will be worn by patients before and during surgery of Hallux valgus to realize hypnosis.
Virtual mask with 2 types of voice: female voice and male voice. Several types of image or music to choice by patient.
Without hypnosisOther
No hypnosis during surgery of Hallux valgus.
| Study group | Role | What they receive |
|---|---|---|
| hypnosis group | Experimental | Mask-wearing as hypnosis method for patients in this arm. Receives: Device: Mask-wearing hypnosis |
| comparator group | Sham comparator | No hypnosis for patients in this arm. Receives: Other: Without hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety assessment at baseline
The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.
Measured: baseline, pre-intervention
Anxiety assessment after the surgery
The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.
Measured: immediately after the surgery
Secondary outcomes (3)
Analgesic taken
Dose of analgesic taken will be added up.
Measured: at the end of study, an average of 1 day
Duration of stay
Duration of stay before discharge of hospital.
Measured: at the end of study, an average of 1 day
Pain assessment
EVA score, a french auto evaluation tool will be used for pain.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start7 Jan 2021
- Primary completion17 May 2022
- Study completion17 May 2022
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 Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe MENIGAUX, MD, Principal investigator, Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHPMarie-Hélène SANDIFORD, Study director, Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711278
- Sponsor's protocol ID
- APHP201445
- Other IDs
- 2019-A03316-51
- Acronym
- PACAH-UCA HV
- Status last verified
- Nov 2024
- First submitted
- 7 Jan 2021
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ganry L, Hersant B, Sidahmed-Mezi M, Dhonneur G, Meningaud JP. Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery. J Stomatol Oral Maxillofac Surg. 2018 Sep;119(4):257-261. doi: 10.1016/j.jormas.2017.12.010. Epub 2018 Jan 6.
PubMed 29317347
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis Mask in Pre-operative Anxiety Management in Ambulatory Surgery Patients: Using Virtual Reality
- ClinicalTrials.gov ID
- NCT04711278
- Acronym / sponsor ID
- PACAH-UCA HV / APHP201445
- Conditions
- Hallux Valgus, Surgery
- Keywords
- hallux valgus, hypnosis, pre-operative anxiety, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 15 Jan 2021 (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.
The primary objective is to evaluate the impact on pre-operative anxiety management of using the virtual reality mask for surgery of hallux valgus.
Detailed description
As secondary objectives, the study aims
- to evaluate post-operative analgesic according to non-drug pre-operative hypnosis, measured by reduction in analgesic intake, and by evaluate of pain;
- to evaluate factors which permitting discharge rapidly from hospital in case of hypnosis with virtual reality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypnosis group | Experimental | Device: Mask-wearing hypnosisMask-wearing as hypnosis method for patients in this arm. |
| comparator group | Sham comparator | Other: Without hypnosisNo hypnosis for patients in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient ≥ 18 years;
- Autonomous patient living at home;
- Affiliated to a social security scheme;
- Informed consent signed by patient;
- Patient will undergo a planned ambulatory surgery for hallux valgus.
Key exclusion criteria (5 listed)
- Inability to understand STAI-A questionnaire;
- Patient refusal;
- Patient underwent a bilateral surgery;
- Patient judicial decision;
- Covered by french AME health system.
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 |
|---|---|---|
| Mask-wearing hypnosisVirtual mask will be worn by patients before and during surgery of Hallux valgus to realize hypnosis. Virtual mask with 2 types of voice: female voice and male voice. Several types of image or music to choice by patient. | Device | hypnosis group |
| Without hypnosisNo hypnosis during surgery of Hallux valgus. | Other | comparator group |
Primary outcome
Anxiety assessment at baseline
Time frame: baseline, pre-intervention
The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.
Anxiety assessment after the surgery
Time frame: immediately after the surgery
The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.
3 secondary outcomes
Analgesic taken
Time frame: at the end of study, an average of 1 day
Duration of stay
Time frame: at the end of study, an average of 1 day
Pain assessment
Time frame: day 1
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 11 Feb 2025.
- Background: PubMed 29317347Ganry L, Hersant B, Sidahmed-Mezi M, Dhonneur G, Meningaud JP. Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery. J Stomatol Oral Maxillofac Surg. 2018 Sep;119(4):257-261. doi: 10.1016/j.jormas.2017.12.010. Epub 2018 Jan 6.
- 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.
Christophe MENIGAUX, MD principal investigator
Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP
Marie-Hélène SANDIFORD study director
Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mask-wearing hypnosis and Without hypnosis in people with Hallux Valgus and Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 5 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 11 Feb 2025. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Anxiety assessment at baseline (time frame: baseline, pre-intervention). The study lists 2 primary outcomes in all. 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 NCT04711278, 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 11 Feb 2025.