Back to results

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

Primary Purpose

Hallux Valgus, Surgery

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Virtual reality

Droleptan

Propofol

Sufentanyl

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring virtual reality, pain, anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinique Saint Jean

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual reality

Drug sedation

Arm Description

The virtual reality device will consist of the virtual reality headset and headphones for full immersion.

The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Patient satisfaction questionnaire

Concerns all patients Numeric scale numbered from 0 to 10. 0: unsatisfied 10 : very satisfied

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

Full Information

NCT ID

NCT03677323

First Posted

September 13, 2018

Last Updated

March 25, 2019

Sponsor

Clinique Saint Jean, France

1. Study Identification

Unique Protocol Identification Number

NCT03677323

Brief Title

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

Acronym

VRBLOC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

January 2, 2019 (Actual)

Primary Completion Date

February 21, 2019 (Actual)

Study Completion Date

February 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clinique Saint Jean, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hallux Valgus, Surgery

Keywords

virtual reality, pain, anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual reality

Arm Type

Experimental

Arm Description

The virtual reality device will consist of the virtual reality headset and headphones for full immersion.

Arm Title

Drug sedation

Arm Type

Active Comparator

Arm Description

The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.

Intervention Type

Device

Intervention Name(s)

Virtual reality

Other Intervention Name(s)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Droleptan

Other Intervention Name(s)

Sedation

Intervention Description

Venous administration of 1.25 mg of Droleptan

Intervention Type

Drug

Intervention Name(s)

Propofol

Other Intervention Name(s)

Sedation

Intervention Description

Venous administration of 20 mg of Propofol

Intervention Type

Drug

Intervention Name(s)

Sufentanyl

Other Intervention Name(s)

Sedation

Intervention Description

Venous administration of 5 μg of Sufentanyl.

Primary Outcome Measure Information:

Title

Digital visual scale to assess pain of patients during the treatment

Description

Numeric scale numbered from 0 to 10. 0: no pain 10 : worst possible pain

Time Frame

5 min after the first nerve punction

Title

Digital visual scale to assess anxiety of patients during the treatment

Description

Numeric scale numbered from 0 to 10. 0: no anxiety 10 : worst possible anxiety

Time Frame

5 min after the first nerve punction

Secondary Outcome Measure Information:

Title

Patient satisfaction questionnaire

Description

Concerns all patients Numeric scale numbered from 0 to 10. 0: unsatisfied 10 : very satisfied

Time Frame

5 min after the last nerve punction

Title

Patient comfort assessment questionnaire

Description

Time Frame

5 min after the last nerve punction

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas PILLANT, MD

Organizational Affiliation

Clinique Saint Jean, Montpellier

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinique Saint Jean

City

Montpellier

ZIP/Postal Code

34090

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19377147

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.

Results Reference

background

PubMed Identifier

19955069

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. doi: 10.14219/jada.archive.2009.0102.

Results Reference

background

PubMed Identifier

20509069

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.

Results Reference

background

PubMed Identifier

19230769

Citation

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.

Results Reference

background

PubMed Identifier

19111995

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.

Results Reference

background

PubMed Identifier

16360473

Citation

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.

Results Reference

background

PubMed Identifier

7488491

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs