SurgeryRELAXNCT06436118
Evaluation of the Use of the RELAX® Glasses on the Anxiety of Patients Undergoing Emergency Hand Surgery Under Locoregional Anesthesia
A study testing RELAX® glasses in people with Surgery, run by Centre Hospitalier de Valenciennes at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- RELAX® glasses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2022to 6 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Surgery
- Being tested
- RELAX® glasses
- Keywords
- Audiovisual sedation, anxiety, hand surgery, locoregional anesthesia
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELAX® glassesBehavioural
Glasses which are a solution of audiovisual sedation by positive distraction for hospital medical use.
| Study group | Role | What they receive |
|---|---|---|
| Group with RELAX® glasses | Experimental | Not described Receives: Behavioral: RELAX® glasses |
| Group without RELAX® glasses | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in visual analogue scale anxiety scores after emergency hand surgery
The visual analogue anxiety scale from 0 to 10, with 0 meaning no anxiety and 10 very high anxiety.
Measured: In the 5 minutes after the end of emergency hand surgery
Secondary outcomes (5)
Overall satisfaction between the group using RELAX glasses and the group following the usual course (without RELAX glasses) measured by a visual analogue scale
The visual analogue satisfaction scale ranges from 0 to 10, with 0 meaning unsatisfaction and 10 indicating very high satisfaction.
Measured: Immediate postoperative
Variation in pain between entering and leaving the operating theatre between the 2 arms using a visual analogue scale
The visual analogue pain scale ranges from 0 to 10, with 0 meaning non pain and 10 meaning very high pain
Measured: In the 5 minutes after the end of emergency hand surgery
Rate of patients receiving at least one additional analgesic
Measured: Immediate after locoregional anaesthesia
Rate of patients receiving at least one additional anxiolytic
Measured: Immediate after locoregional anaesthesia
Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score
Only in patients receiving RELAX glasses : If the STAI-YB score is higher than 65, the patient is considered to have pre-existing anxiety.
Measured: 7-days after emergency hand surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start2 May 2022
- Primary completion30 Aug 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valenciennes
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436118
- Sponsor's protocol ID
- 2021-05
- Acronym
- RELAX
- Status last verified
- May 2024
- First submitted
- 29 Aug 2022
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06436118
- Acronym / sponsor ID
- RELAX / 2021-05
- Conditions
- Surgery
- Keywords
- Audiovisual sedation, anxiety, hand surgery, locoregional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Centre Hospitalier de ValenciennesResearch network
- Study start
- 2 May 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with RELAX® glasses | Experimental | Behavioral: RELAX® glasses |
| Group without RELAX® glasses | No intervention | – |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RELAX® glassesGlasses which are a solution of audiovisual sedation by positive distraction for hospital medical use. | Behavioural | Group with RELAX® glasses |
Primary outcome
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.
5 secondary outcomes
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
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
Rate of patients receiving at least one additional analgesic
Time frame: Immediate after locoregional anaesthesia
Rate of patients receiving at least one additional anxiolytic
Time frame: Immediate after locoregional anaesthesia
Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score
Time frame: 7-days after emergency hand surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RELAX® glasses in people with Surgery, run by Centre Hospitalier de Valenciennes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.