Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block.

Surgery Clinical Trial

— VRBLOC  

Official title:

Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677323
• Other study ID #: LOCAL2017-TP02
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: February 21, 2019

Study information

• Verified date: March 2019
• Source: Clinique Saint Jean, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 21, 2019
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Patient refusing locoregional anesthesia

• Patient under the protection of justice, under curatorship or under tutorship

• Patient undergoing anxiolytic or antidepressant treatment

• Photosensitive epileptic patient

Related Conditions & MeSH terms

• Hallux Valgus
• Surgery

Intervention

Device:
• 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:
• 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.

Locations

Country	Name	City	State
France	Clinique Saint Jean	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Saint Jean, France

Country where clinical trial is conducted

France, 

References & Publications (7)

Burt DE. Virtual reality in anaesthesia. Br J Anaesth. 1995 Oct;75(4):472-80. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nilsson S, Finnström B, Kokinsky E, Enskär 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. — View Citation

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. — View Citation

Wright JL, Hoffman HG, Sweet RM. Virtual reality as an adjunctive pain control during transurethral microwave thermotherapy. Urology. 2005 Dec;66(6):1320. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 min after the first nerve punction
Primary	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	5 min after the first nerve punction
Secondary	Patient satisfaction questionnaire	Concerns all patients Numeric scale numbered from 0 to 10. 0: unsatisfied 10 : very satisfied	5 min after the last nerve punction
Secondary	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	5 min after the last nerve punction