AnxietyAMBLUMEENNCT05590078
Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery
A study testing Virtual reality session, State Trait Anxiety Inventory and Virtual Reality Satisfaction Score in people with Anxiety, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This study evaluate the interest of Virtual Reality to reduce the preoperative anxiety in patients who undergo to ambulatory surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Virtual reality session, State Trait Anxiety Inventory and Virtual Reality Satisfaction Score
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2023to 18 Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II (classification of the American Society of Anesthesiologists).
- Ambulatory surgery scheduled
- Score STAI YA > 45
- Affiliated to a social security
- Understanding the study and signing the informed consent
Who cannot join
- Contraindications for Midazolam
- 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
Show all 9Show fewer
- Person unable to express their consent
- Minor patient or patient under curatorship or guardianship
- patient participating in another interventional clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluate the interest of Virtual Reality to reduce the preoperative anxiety in patients who undergo to ambulatory surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment.
- Conditions
- Anxiety
- Being tested
- Virtual reality session, State Trait Anxiety Inventory, Virtual Reality Satisfaction Score, Perioperative care satisfaction score
- Keywords
- Virtual reality, preoperative anxiety, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality sessionDevice
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 InventoryOther
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 ScoreOther
Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session
Perioperative care satisfaction scoreOther
Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | 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. Receives: Other: State Trait Anxiety Inventory; Other: Perioperative care satisfaction score |
| Virtual reality group | Experimental | 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. Receives: Device: Virtual reality session; Other: State Trait Anxiety Inventory; Other: Virtual Reality Satisfaction Score; Other: Perioperative care satisfaction score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Anxiety
Measured by State-Trait Anxiety Inventory (STAI YA) . The scale includes twenty items.. Each question is assigned 1 to 4 points, giving a score of 20 (low anxiety) to 80 points (high anxiety)
Measured: D0 : baseline and right before going to surgery
Secondary outcomes (9)
Number of milligrams of midazolam administered
Comparison of midazolam premedication to reduce preoperative anxiety between control group and virtual reality group.
Measured: D0 (before surgery)
Percentage of patients with intraoperative remifentanil required
Comparison in term of Number of case where the utilisation of remifentanil was necessary in peroperative between control group and virtual reality group.
Measured: D0 (during surgery)
Pain score
Pain assessment with numerical scale from 0 (low) to 10(high)
Measured: D0 (after surgery)
Morphine dose used
Comparison of morphine dose used in recovery room between control group and virtual reality group
Measured: D0 (after surgery in recovery room)
Perioperative care satisfaction score
Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care. 5 answer possible :Very satisfied - satisfied- Neither satisfied nor unsatisfied- Unsatisfied - Very unsatisfied
Measured: through study completion, 1 day
Nature and severity of adverse events
Comparison of adverse event during hospitalization between control group and virtual reality group
Measured: through study completion, 1 day
Adverse events related to the virtual reality session
Nature and severity of adverse events related to the virtual reality session
Measured: through study completion, 1 day
Virtual Reality Satisfaction Score
Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session. 5 items scored from 0 (low) to 10 (high)
Measured: through study completion, 1 day
Experience of the caregiver
Experience of the caregiver concerning the implementation of virtual reality in the outpatient department before surgery . 2 items scored from 0 (low) to 10 (high)
Measured: D0 (before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start21 Mar 2023
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud FRIGGERI, Principal investigator, Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590078
- Sponsor's protocol ID
- 69HCL20_0102
- Acronym
- AMBLUMEEN
- Status last verified
- Dec 2023
- First submitted
- 14 Oct 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery
- ClinicalTrials.gov ID
- NCT05590078
- Acronym / sponsor ID
- AMBLUMEEN / 69HCL20_0102
- Conditions
- Anxiety
- Keywords
- Virtual reality, preoperative anxiety, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 21 Oct 2022 (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.
This study evaluate the interest of Virtual Reality to reduce the preoperative anxiety in patients who undergo to ambulatory surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: State Trait Anxiety Inventory, Other: Perioperative care satisfaction scoreGeneral routine care. This group will undergo to ambulatory surgery without preoperative virtual reality session. Will be applied the usual treatment to reduce preoperative anxiety. |
| Virtual reality group | Experimental | Device: Virtual reality session, Other: State Trait Anxiety Inventory, Other: Virtual Reality Satisfaction Score, Other: Perioperative care satisfaction scoreVirtual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA I-II (classification of the American Society of Anesthesiologists).
- Ambulatory surgery scheduled
- Score STAI YA > 45
- Affiliated to a social security
- Understanding the study and signing the informed consent
Key exclusion criteria (9 listed)
- Contraindications for Midazolam
- 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
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 |
|---|---|---|
| Virtual reality sessionThe 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. | Device | Virtual reality group |
| State Trait Anxiety InventoryThe 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) | Other | Control group, Virtual reality group |
| Virtual Reality Satisfaction ScoreLikert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session | Other | Virtual reality group |
| Perioperative care satisfaction scoreLikert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care | Other | Control group, Virtual reality group |
Primary outcome
Change of Anxiety
Time frame: D0 : baseline and right before going to surgery
Measured by State-Trait Anxiety Inventory (STAI YA) . The scale includes twenty items.. Each question is assigned 1 to 4 points, giving a score of 20 (low anxiety) to 80 points (high anxiety)
9 secondary outcomes
Number of milligrams of midazolam administered
Time frame: D0 (before surgery)
Percentage of patients with intraoperative remifentanil required
Time frame: D0 (during surgery)
Pain score
Time frame: D0 (after surgery)
Morphine dose used
Time frame: D0 (after surgery in recovery room)
Perioperative care satisfaction score
Time frame: through study completion, 1 day
Nature and severity of adverse events
Time frame: through study completion, 1 day
Adverse events related to the virtual reality session
Time frame: through study completion, 1 day
Virtual Reality Satisfaction Score
Time frame: through study completion, 1 day
Experience of the caregiver
Time frame: D0 (before 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 22 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Arnaud FRIGGERI principal investigator
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality session, State Trait Anxiety Inventory and Virtual Reality Satisfaction Score in people with Anxiety, run by Hospices Civils de Lyon 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 9 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 22 Dec 2023. 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 of Anxiety (time frame: D0 : baseline and right before going to 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 22 Dec 2023.