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Completed

NCT Number: NCT06436118

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

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.

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Key information

Conditions

Surgery Anxiety Disorders Mental Disorders

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RELAX® glasses

Behavioral

Glasses which are a solution of audiovisual sedation by positive distraction for hospital medical use.

Primary outcomes

  1. Change from baseline in visual analogue scale anxiety scores after emergency hand surgery

    Time frame: In the 5 minutes after the end of emergency hand surgery

    The visual analogue anxiety scale from 0 to 10, with 0 meaning no anxiety and 10 very high anxiety.

Secondary outcomes

  1. Overall satisfaction between the group using RELAX glasses and the group following the usual course (without RELAX glasses) measured by a visual analogue scale

    Time frame: Immediate postoperative

    The visual analogue satisfaction scale ranges from 0 to 10, with 0 meaning unsatisfaction and 10 indicating very high satisfaction.

  2. Variation in pain between entering and leaving the operating theatre between the 2 arms using a visual analogue scale

    Time frame: In the 5 minutes after the end of emergency hand surgery

    The visual analogue pain scale ranges from 0 to 10, with 0 meaning non pain and 10 meaning very high pain

  3. Rate of patients receiving at least one additional analgesic

    Time frame: Immediate after locoregional anaesthesia

  4. Rate of patients receiving at least one additional anxiolytic

    Time frame: Immediate after locoregional anaesthesia

  5. Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score

    Time frame: 7-days after emergency hand surgery

    Only in patients receiving RELAX glasses : If the STAI-YB score is higher than 65, the patient is considered to have pre-existing anxiety.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Valenciennes

Network

Registry information

Official study title

Evaluation of the Use of the RELAX® Glasses on the Anxiety of Patients Undergoing Emergency Hand Surgery Under Locoregional Anesthesia Compared to Those Who do Not Use the Glasses

Acronym: RELAX

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 30, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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