Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block.
NCT ID: NCT03677323
Last Updated: 2019-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2019-01-02
2019-02-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures
NCT01376960
A Study to Evaluate Virtual Reality As Adjunct to Anesthesia During Orthopedic Surgery
NCT05112302
The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks
NCT06185608
Ultrasound Guided Single Shot Block of Posterior Tibial Nerve for Postoperative Pain Relief After Hallux Valgus Surgery
NCT02282956
Plantar Compartment Block in Hallux Valgus Ambulatory Surgery
NCT03815422
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Virtual reality
The virtual reality device will consist of the virtual reality headset and headphones for full immersion.
Virtual reality
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.
Drug sedation
The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.
Droleptan
Venous administration of 1.25 mg of Droleptan
Propofol
Venous administration of 20 mg of Propofol
Sufentanyl
Venous administration of 5 μg of Sufentanyl.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Virtual reality
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.
Droleptan
Venous administration of 1.25 mg of Droleptan
Propofol
Venous administration of 20 mg of Propofol
Sufentanyl
Venous administration of 5 μg of Sufentanyl.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Major patient requiring a Hallux Valgus surgery
* Patient who received information about study and signes a consent to participate in the study
Exclusion Criteria
* 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
* Patient refusing locoregional anesthesia
* Patient under the protection of justice, under curatorship or under tutorship
* Patient undergoing anxiolytic or antidepressant treatment
* Photosensitive epileptic patient
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clinique Saint Jean, France
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas PILLANT, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique Saint Jean, Montpellier
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinique Saint Jean
Montpellier, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Furman 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.
Patterson 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.
Nilsson 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.
Konstantatos 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.
Wright 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.
Burt DE. Virtual reality in anaesthesia. Br J Anaesth. 1995 Oct;75(4):472-80. doi: 10.1093/bja/75.4.472. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LOCAL2017-TP02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.