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Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery (AMBLUMEEN)

Primary Purpose

Anxiety

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Virtual reality session

State Trait Anxiety Inventory

Virtual Reality Satisfaction Score

Perioperative care satisfaction score

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Virtual reality, preoperative anxiety, anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Person unable to express their consent
Minor patient or patient under curatorship or guardianship
patient participating in another interventional clinical trial

Sites / Locations

Centre Hospitalier Lyon SudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control group

Virtual reality group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of milligrams of midazolam administered

Comparison of midazolam premedication to reduce preoperative anxiety between control group and virtual reality group.

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.

Pain score

Pain assessment with numerical scale from 0 (low) to 10(high)

Morphine dose used

Comparison of morphine dose used in recovery room between control group and virtual reality group

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

Nature and severity of adverse events

Comparison of adverse event during hospitalization between control group and virtual reality group

Adverse events related to the virtual reality session

Nature and severity of adverse events related to the virtual reality session

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)

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)

Full Information

NCT ID

NCT05590078

First Posted

October 14, 2022

Last Updated

March 24, 2023

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT05590078

Brief Title

Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery

Acronym

AMBLUMEEN

Official Title

Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 21, 2023 (Actual)

Primary Completion Date

December 21, 2023 (Anticipated)

Study Completion Date

December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety

Keywords

Virtual reality, preoperative anxiety, anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Other

Arm Description

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.

Arm Title

Virtual reality group

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Virtual reality session

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

State Trait Anxiety Inventory

Intervention Description

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)

Intervention Type

Other

Intervention Name(s)

Virtual Reality Satisfaction Score

Intervention Description

Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session

Intervention Type

Other

Intervention Name(s)

Perioperative care satisfaction score

Intervention Description

Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care

Primary Outcome Measure Information:

Title

Change of Anxiety

Description

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)

Time Frame

D0 : baseline and right before going to surgery

Secondary Outcome Measure Information:

Title

Number of milligrams of midazolam administered

Description

Comparison of midazolam premedication to reduce preoperative anxiety between control group and virtual reality group.

Time Frame

D0 (before surgery)

Title

Percentage of patients with intraoperative remifentanil required

Description

Comparison in term of Number of case where the utilisation of remifentanil was necessary in peroperative between control group and virtual reality group.

Time Frame

D0 (during surgery)

Title

Pain score

Description

Pain assessment with numerical scale from 0 (low) to 10(high)

Time Frame

D0 (after surgery)

Title

Morphine dose used

Description

Comparison of morphine dose used in recovery room between control group and virtual reality group

Time Frame

D0 (after surgery in recovery room)

Title

Perioperative care satisfaction score

Description

Time Frame

through study completion, 1 day

Title

Nature and severity of adverse events

Description

Comparison of adverse event during hospitalization between control group and virtual reality group

Time Frame

through study completion, 1 day

Title

Adverse events related to the virtual reality session

Description

Nature and severity of adverse events related to the virtual reality session

Time Frame

through study completion, 1 day

Title

Virtual Reality Satisfaction Score

Description

Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session. 5 items scored from 0 (low) to 10 (high)

Time Frame

through study completion, 1 day

Title

Experience of the caregiver

Description

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)

Time Frame

D0 (before surgery)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Person unable to express their consent Minor patient or patient under curatorship or guardianship patient participating in another interventional clinical trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Arnaud Pr FRIGGERI

Phone

04 78 86 56 47

arnaud.friggeri@chu-lyon.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Charles Hervé Dr VACHERON

charles-herve.vacheron@chu-lyon.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnaud FRIGGERI

Organizational Affiliation

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Lyon Sud

City

Pierre-Bénite

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arnaud FRIGGERI

First Name & Middle Initial & Last Name & Degree

Arnaud FRIGGERI

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery

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