Hallux ValgusVRBLOCNCT03677323
Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block.
A study testing Virtual reality, Droleptan and Propofol in people with Hallux Valgus and Surgery, run by Clinique Saint Jean, France at 1 site in France.
Trial summary
The purpose of this study is to observe or not a reduction on pain and anxiety felt by the patient when performing an ultrasound-controlled ankle block in preparation for forefoot surgery, using a virtual reality device instead of drug sedation. 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?
- Virtual reality, Droleptan and Propofol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2019to 21 Feb 2019
- 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 with medical insurance
- Major patient requiring a Hallux Valgus surgery
- Patient who received information about study and signes a consent to participate in the study
Who cannot join
- Minor patient
- Patient participating in another interventional study
- Patient refusing to sign the consent form
- Patient for whom it is impossible to give informed information
- Patient who had previously undergone forefoot surgery under locoregional anesthesia
- Patient with poor skin condition or infection at puncture sites
Show all 10Show fewer
- Patient refusing locoregional anesthesia
- Patient under the protection of justice, under curatorship or under tutorship
- Patient undergoing anxiolytic or antidepressant treatment
- Photosensitive epileptic patient
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to observe or not a reduction on pain and anxiety felt by the patient when performing an ultrasound-controlled ankle block in preparation for forefoot surgery, using a virtual reality device instead of drug sedation.
Read the detailed description
Currently, in preparation for forefoot surgery, the realization of the ankle block is accompanied by drug sedation.
The investigator's randomized study aims to compare the anxiety and pain experienced by patients who have benefited from drug sedation with those of patients who benefited from the virtual reality device at the time of the realization of the ankle block.
- Conditions
- Hallux Valgus, Surgery
- Being tested
- Virtual reality, Droleptan, Propofol, Sufentanyl
- Keywords
- virtual reality, pain, anxiety
- Medical subject headings
- Hallux Valgus, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Also called VR
The patient will have the choice between different environments and the use of this device will remain under the control of the medical team.
The patient will wear the virtual reality device at the time of the completion of the ankle block and will remove it once the nerve puncture is complete.
DroleptanDrug
Also called Sedation
Venous administration of 1.25 mg of Droleptan
PropofolDrug
Also called Sedation
Venous administration of 20 mg of Propofol
SufentanylDrug
Also called Sedation
Venous administration of 5 μg of Sufentanyl.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | The virtual reality device will consist of the virtual reality headset and headphones for full immersion. Receives: Device: Virtual reality |
| Drug sedation | Active comparator | The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol. Receives: Drug: Droleptan; Drug: Propofol; Drug: Sufentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital visual scale to assess pain of patients during the treatment
Numeric scale numbered from 0 to 10. 0: no pain 10 : worst possible pain
Measured: 5 min after the first nerve punction
Digital visual scale to assess anxiety of patients during the treatment
Numeric scale numbered from 0 to 10. 0: no anxiety 10 : worst possible anxiety
Measured: 5 min after the first nerve punction
Secondary outcomes (2)
Patient satisfaction questionnaire
Concerns all patients Numeric scale numbered from 0 to 10. 0: unsatisfied 10 : very satisfied
Measured: 5 min after the last nerve punction
Patient comfort assessment questionnaire
Concerns all patients. This is a question to determine their comfort levels during the experiment. Numeric scale numbered from 1 to 5.
- : very comfortable
- : comfortable
- : less comfortable
- : uncomfortable
- : very uncomfortable
Measured: 5 min after the last nerve punction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start2 Jan 2019
- Primary completion21 Feb 2019
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Saint Jean, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas PILLANT, MD, Principal investigator, Clinique Saint Jean, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677323
- Sponsor's protocol ID
- LOCAL2017-TP02
- Acronym
- VRBLOC
- Status last verified
- Mar 2019
- First submitted
- 13 Sep 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200.
PubMed 19377147Furman E, Jasinevicius TR, Bissada NF, Victoroff KZ, Skillicorn R, Buchner M. Virtual reality distraction for pain control during periodontal scaling and root planing procedures. J Am Dent Assoc. 2009 Dec;140(12):1508-16. doi: 10.14219/jada.archive.2009.0102.
PubMed 19955069Patterson DR, Jensen MP, Wiechman SA, Sharar SR. Virtual reality hypnosis for pain associated with recovery from physical trauma. Int J Clin Exp Hypn. 2010 Jul;58(3):288-300. doi: 10.1080/00207141003760595.
PubMed 20509069Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20.
PubMed 19230769Konstantatos AH, Angliss M, Costello V, Cleland H, Stafrace S. Predicting the effectiveness of virtual reality relaxation on pain and anxiety when added to PCA morphine in patients having burns dressings changes. Burns. 2009 Jun;35(4):491-9. doi: 10.1016/j.burns.2008.08.017. Epub 2008 Dec 27.
PubMed 19111995Wright JL, Hoffman HG, Sweet RM. Virtual reality as an adjunctive pain control during transurethral microwave thermotherapy. Urology. 2005 Dec;66(6):1320. doi: 10.1016/j.urology.2005.06.123.
PubMed 16360473Burt DE. Virtual reality in anaesthesia. Br J Anaesth. 1995 Oct;75(4):472-80. doi: 10.1093/bja/75.4.472. No abstract available.
PubMed 7488491
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block.
- ClinicalTrials.gov ID
- NCT03677323
- Acronym / sponsor ID
- VRBLOC / LOCAL2017-TP02
- Conditions
- Hallux Valgus, Surgery
- Keywords
- virtual reality, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Clinique Saint Jean, FranceUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 19 Sep 2018 (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 purpose of this study is to observe or not a reduction on pain and anxiety felt by the patient when performing an ultrasound-controlled ankle block in preparation for forefoot surgery, using a virtual reality device instead of drug sedation.
Detailed description
Currently, in preparation for forefoot surgery, the realization of the ankle block is accompanied by drug sedation.
The investigator's randomized study aims to compare the anxiety and pain experienced by patients who have benefited from drug sedation with those of patients who benefited from the virtual reality device at the time of the realization of the ankle block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: Virtual realityThe virtual reality device will consist of the virtual reality headset and headphones for full immersion. |
| Drug sedation | Active comparator | Drug: Droleptan, Drug: Propofol, Drug: SufentanylThe sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with medical insurance
- Major patient requiring a Hallux Valgus surgery
- Patient who received information about study and signes a consent to participate in the study
Key exclusion criteria (10 listed)
- Minor patient
- Patient participating in another interventional study
- Patient refusing to sign the consent form
- Patient for whom it is impossible to give informed information
- Patient who had previously undergone forefoot surgery under locoregional anesthesia
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 |
|---|---|---|
| Virtual realityAlso: VRThe patient will have the choice between different environments and the use of this device will remain under the control of the medical team. The patient will wear the virtual reality device at the time of the completion of the ankle block and will remove it once the nerve puncture is complete. | Device | Virtual reality |
| DroleptanAlso: SedationVenous administration of 1.25 mg of Droleptan | Drug | Drug sedation |
| PropofolAlso: SedationVenous administration of 20 mg of Propofol | Drug | Drug sedation |
| SufentanylAlso: SedationVenous administration of 5 μg of Sufentanyl. | Drug | Drug sedation |
Primary outcome
Digital visual scale to assess pain of patients during the treatment
Time frame: 5 min after the first nerve punction
Numeric scale numbered from 0 to 10. 0: no pain 10 : worst possible pain
Digital visual scale to assess anxiety of patients during the treatment
Time frame: 5 min after the first nerve punction
Numeric scale numbered from 0 to 10. 0: no anxiety 10 : worst possible anxiety
2 secondary outcomes
Patient satisfaction questionnaire
Time frame: 5 min after the last nerve punction
Patient comfort assessment questionnaire
Time frame: 5 min after the last nerve punction
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 26 Mar 2019.
- Background: PubMed 19377147Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200.
- Background: PubMed 19955069Furman E, Jasinevicius TR, Bissada NF, Victoroff KZ, Skillicorn R, Buchner M. Virtual reality distraction for pain control during periodontal scaling and root planing procedures. J Am Dent Assoc. 2009 Dec;140(12):1508-16. doi: 10.14219/jada.archive.2009.0102.
- Background: PubMed 20509069Patterson DR, Jensen MP, Wiechman SA, Sharar SR. Virtual reality hypnosis for pain associated with recovery from physical trauma. Int J Clin Exp Hypn. 2010 Jul;58(3):288-300. doi: 10.1080/00207141003760595.
- Background: PubMed 19230769Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20.
- Background: PubMed 19111995Konstantatos AH, Angliss M, Costello V, Cleland H, Stafrace S. Predicting the effectiveness of virtual reality relaxation on pain and anxiety when added to PCA morphine in patients having burns dressings changes. Burns. 2009 Jun;35(4):491-9. doi: 10.1016/j.burns.2008.08.017. Epub 2008 Dec 27.
- Background: PubMed 16360473Wright JL, Hoffman HG, Sweet RM. Virtual reality as an adjunctive pain control during transurethral microwave thermotherapy. Urology. 2005 Dec;66(6):1320. doi: 10.1016/j.urology.2005.06.123.
- Background: PubMed 7488491Burt DE. Virtual reality in anaesthesia. Br J Anaesth. 1995 Oct;75(4):472-80. doi: 10.1093/bja/75.4.472. No abstract available.
- 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.
Thomas PILLANT, MD principal investigator
Clinique Saint Jean, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality, Droleptan and Propofol in people with Hallux Valgus and Surgery, run by Clinique Saint Jean, France 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 3 inclusion and 10 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 26 Mar 2019. 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. 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?
Digital visual scale to assess pain of patients during the treatment (time frame: 5 min after the first nerve punction). 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 NCT03677323, which also lists 7 linked publications.
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 26 Mar 2019.