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Evaluation of the Use of the RELAX® Glasses on the Anxiety of Patients Undergoing Emergency Hand Surgery Under Locoregional Anesthesia

C

Centre Hospitalier de Valenciennes

Status

Completed

Conditions

Surgery

Treatments

Behavioral: RELAX® glasses

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT06436118
2021-05

Details and patient eligibility

About

More than 90% of hand surgery is performed under local anesthesia and can be a source of anxiety, especially in an emergency context. The management of this intraoperative anxiety is essential for the comfort. The use of a virtual reality headset has shown its effectiveness in reducing anxiety in dental surgery or hand surgery under local anesthesia with the WALANT technique. On the other hand, virtual reality and the use of 3D can cause discomfort and side effects such as nausea and dizziness. It is known that audiovisual distraction also effectively reduces pain and anxiety in patients with fewer side effects.

The investigators have therefore chosen to use the RELAX® glasses. There are no publications examining the effectiveness of positive distraction as a non-pharmacological agent to improve the patient experience during emergency management in the operating room in the context of hand surgery under locoregional anesthesia. The investigatos would like to study its action on the anxiety, pain and global satisfaction.

Enrollment

171 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients treated for hand surgery under emergency locoregional anesthesia (Wounds, fractures and infections of the hand and wrist).
  • Over 15 years and 3 months of age on the day of inclusion.
  • Patient with written consent or additional parental consent in the case of minor patients.
  • Socially insured patient.
  • Patient willing to comply with all study procedures and duration.

Exclusion criteria

  • Medical history contraindicating RELAX glasses: claustrophobia.
  • Known and current alcohol and/or illicit drug abuse that may interfere with patient safety and/or compliance.
  • Any condition that would make the patient unfit for the study: current presence of cognitive impairment (MMS <15), severe psychiatric disorders (bipolar disorder, psychotic disorders according to the DSM-V classification).
  • Pregnant or breastfeeding woman.
  • Patient under court protection.
  • Patient participating in another study.
  • Patient's refusal to use the headset.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

171 participants in 2 patient groups

Group with RELAX® glasses
Experimental group
Treatment:
Behavioral: RELAX® glasses
Group without RELAX® glasses
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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