Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery
NCT ID: NCT05590078
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2023-03-21
2023-10-18
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
General routine care. This group will undergo to ambulatory surgery without preoperative virtual reality session. Will be applied the usual treatment to reduce preoperative anxiety.
State Trait Anxiety Inventory
The State Trait Anxiety Inventory (State anxiety) is a questionnaire given to adults that shows how strong a person's feelings of anxiety are "right now, just now". The score is measured on arrival in the outpatient department and just before going into the intervention room (= after the virtual reality session for the experimental group)
Perioperative care satisfaction score
Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care
Virtual reality group
Virtual Reality. This group will undergo to 20 min virtual reality before ambulatory surgery. In addition to virtual reality session, will be applied the usual treatment to reduce preoperative anxiety, after virtual reality, if necessary.
Virtual reality session
The 20-minute virtual reality session, in the outpatient department before surgery, immerses the patient in calm environments combined with music therapy and breathing exercises to relax and reduce anxiety.
State Trait Anxiety Inventory
The State Trait Anxiety Inventory (State anxiety) is a questionnaire given to adults that shows how strong a person's feelings of anxiety are "right now, just now". The score is measured on arrival in the outpatient department and just before going into the intervention room (= after the virtual reality session for the experimental group)
Virtual Reality Satisfaction Score
Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session
Perioperative care satisfaction score
Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care
Interventions
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Virtual reality session
The 20-minute virtual reality session, in the outpatient department before surgery, immerses the patient in calm environments combined with music therapy and breathing exercises to relax and reduce anxiety.
State Trait Anxiety Inventory
The State Trait Anxiety Inventory (State anxiety) is a questionnaire given to adults that shows how strong a person's feelings of anxiety are "right now, just now". The score is measured on arrival in the outpatient department and just before going into the intervention room (= after the virtual reality session for the experimental group)
Virtual Reality Satisfaction Score
Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session
Perioperative care satisfaction score
Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care
Eligibility Criteria
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Inclusion Criteria
* Ambulatory surgery scheduled
* Score STAI YA \> 45
* Affiliated to a social security
* Understanding the study and signing the informed consent
Exclusion Criteria
* Patients with disorders not compatible with virtual reality: severe cognitive or psychiatric disorders, blindness, claustrophobia, epilepsy
* Patient with a pacemaker of others implantable medical devices
* patient with burns or wounds on the upper face or scalp
* Visual hallucinations
* Contagious disease by air or indirect contact
* Person unable to express their consent
* Minor patient or patient under curatorship or guardianship
* patient participating in another interventional clinical trial
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Arnaud FRIGGERI
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Locations
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Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Countries
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Other Identifiers
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69HCL20_0102
Identifier Type: -
Identifier Source: org_study_id