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Atmospheric Projection in the Emergency Department (AERIAL-MED)

Primary Purpose

Pain, Acute, Anxiety Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Immersive atmospheric projection
Minimal atmospheric projection
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

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

Inclusion Criteria: Aged ≥18 ; Patient requiring one of the following treatment procedures : suturing, plaster cast placement and/or repositioning, fracture or dislocation reduction, ascites puncture, pleural puncture, lumbar puncture. Exclusion Criteria: Patient clinically unstable; Patient incapable of discernment or consent ; Altered mental status (cognitive disorders, mental retardation, acute state of confusion, acute psychosis); Alcoholic patient with University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) score of 10/10 ; Patient hard of hearing ; Patient with visual impairments preventing him/her from perceiving his/her environment ; Patient unable to understand the use of visual analog scales (VAS); Impaired sensitivity of the part of the body where the medical intervention is to take place; Planned use of analgesia/sedation with a dissociative agent (midazolam, ketamine, propofol); Incarcerated patient ; Patient transferred from another hospital ; Patient having already participated in this study during a previous consultation in the emergency department of the Centre Hospitalier Universitaire Vaudois.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Atmospheric 3D video projection

    Atmospheric 3D color projection

    Arm Description

    Patients in the interventional arm will watch an immersive atmospheric video projection on the walls of their examination room.

    Patients in the interventional arm will look at a neutral color of their choice projected on the walls of their examination room.

    Outcomes

    Primary Outcome Measures

    Procedural Pain
    Maximal pain intensity experienced by the patient during the medical procedure, assessed using a Visual Analogic Scale from 0mm to 100mm anchored with "No pain/Worst pain imaginable"
    Procedural Anxiety
    Maximal anxiety intensity felt by the patient during the medical procedure, assessed using a Visual Analogic Scale from 0mm to 100mm anchored with "Not at all anxious/Extremely anxious."

    Secondary Outcome Measures

    Telepresence
    Telepresence will be assessed by the Igroupe Presence Questionnaire composed of 14 statements grouped into 4 categories: (1) spatial presence (the sense of being physically present in the virtual environment), (2) involvement (attention devoted to the virtual environment and experienced involvement), (3) experienced realism (the subjective experience of realism in the virtual environment), and (4) the general sense of being in the virtual environment. Each question is rated on a 7-point scale (0 to 6), with greater scores indicating a greater sense of presence in the projected environment
    Dissociation
    Dissociation of the patients represents the mental separation of the patient from their environment, assessed using a Visual Analogic Scale from 0mm to 100mm, anchored with "most present in the clinical environment / the most immersed in the projected environment "
    Appreciation of the atmospheric projection
    Appreciation of the atmospheric projection by the patient, using a Visual Analogic Scale from 0mm to 100mm, anchored with "least appreciative/most appreciative)
    Patient's comfort
    Patient's comfort during the atmospheric projection, assessed using a Visual Analogic Scale from 0mm to 100mm, anchored with "least comfortable /most comfortable"
    Procedural support
    Procedural support provided by the projection during the medical procedure according to the physician in charge of the procedure, assessed using a 3-level Likert scale (yes-neutral-no)
    Procedural disturbance
    Procedural disturbance for physicians caused by the atmospheric projection interfering with the medical procedure, assessed using a 3-level Likert scale (yes-neutral-no)
    Cybercinetosis
    Cybercinetosis is a symptom similar to motion sickness that occurs with exposure to a virtual environment, will be assessed using a 3-level Likert scale (light-moderate-severe)
    Pain catastrophizing
    Pain catastrophizing will be assessed using the French version of the Situational Catastrophizing Questionnaire, a 6-question adaptation of the Pain Catastrophizing Scale

    Full Information

    First Posted
    June 28, 2023
    Last Updated
    July 22, 2023
    Sponsor
    University of Lausanne Hospitals
    Collaborators
    University of Lausanne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05967988
    Brief Title
    Atmospheric Projection in the Emergency Department
    Acronym
    AERIAL-MED
    Official Title
    AtmosphEric pRojection for paIn and Anxiety reLated to Minor Medical Procedures in the Emergency Department: a Monocentric, Parallel, Randomized, Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 14, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Lausanne Hospitals
    Collaborators
    University of Lausanne

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to learn about the reduction of pain and anxiety during a minor procedure in the emergency department on adult patients through the visualisation of atmospheric projection as a distraction mean. The main question it aims to answer is : Can the atmospheric projection of a video reduce pain and anxiety in adult patients receiving painful procedures in the emergency department ? Participants will look at an atmospheric projection (projection of a media on the walls and roof around the patient) while receiving their planned care procedures. Researchers will compare an active group watching a video with a control group watching a simple colored light to see if the visualisation of an atmospheric projected video reduces pain and anxiety more than the visualisation of a colored light does.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    The patient will assess the outcome him/herself. The statistician will also be blinded to the group assignment.
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Atmospheric 3D video projection
    Arm Type
    Experimental
    Arm Description
    Patients in the interventional arm will watch an immersive atmospheric video projection on the walls of their examination room.
    Arm Title
    Atmospheric 3D color projection
    Arm Type
    Sham Comparator
    Arm Description
    Patients in the interventional arm will look at a neutral color of their choice projected on the walls of their examination room.
    Intervention Type
    Device
    Intervention Name(s)
    Immersive atmospheric projection
    Intervention Description
    Projection of computer-generated videos or videos of real moving landscapes on the walls of the examination room
    Intervention Type
    Device
    Intervention Name(s)
    Minimal atmospheric projection
    Intervention Description
    Projection of a colors on the walls on the walls of the examination room
    Primary Outcome Measure Information:
    Title
    Procedural Pain
    Description
    Maximal pain intensity experienced by the patient during the medical procedure, assessed using a Visual Analogic Scale from 0mm to 100mm anchored with "No pain/Worst pain imaginable"
    Time Frame
    Just after the procedure
    Title
    Procedural Anxiety
    Description
    Maximal anxiety intensity felt by the patient during the medical procedure, assessed using a Visual Analogic Scale from 0mm to 100mm anchored with "Not at all anxious/Extremely anxious."
    Time Frame
    Just after the procedure
    Secondary Outcome Measure Information:
    Title
    Telepresence
    Description
    Telepresence will be assessed by the Igroupe Presence Questionnaire composed of 14 statements grouped into 4 categories: (1) spatial presence (the sense of being physically present in the virtual environment), (2) involvement (attention devoted to the virtual environment and experienced involvement), (3) experienced realism (the subjective experience of realism in the virtual environment), and (4) the general sense of being in the virtual environment. Each question is rated on a 7-point scale (0 to 6), with greater scores indicating a greater sense of presence in the projected environment
    Time Frame
    Just after the procedure
    Title
    Dissociation
    Description
    Dissociation of the patients represents the mental separation of the patient from their environment, assessed using a Visual Analogic Scale from 0mm to 100mm, anchored with "most present in the clinical environment / the most immersed in the projected environment "
    Time Frame
    Just after the procedure
    Title
    Appreciation of the atmospheric projection
    Description
    Appreciation of the atmospheric projection by the patient, using a Visual Analogic Scale from 0mm to 100mm, anchored with "least appreciative/most appreciative)
    Time Frame
    Just after the procedure
    Title
    Patient's comfort
    Description
    Patient's comfort during the atmospheric projection, assessed using a Visual Analogic Scale from 0mm to 100mm, anchored with "least comfortable /most comfortable"
    Time Frame
    Just after the procedure
    Title
    Procedural support
    Description
    Procedural support provided by the projection during the medical procedure according to the physician in charge of the procedure, assessed using a 3-level Likert scale (yes-neutral-no)
    Time Frame
    After the procedure
    Title
    Procedural disturbance
    Description
    Procedural disturbance for physicians caused by the atmospheric projection interfering with the medical procedure, assessed using a 3-level Likert scale (yes-neutral-no)
    Time Frame
    Just after the procedure
    Title
    Cybercinetosis
    Description
    Cybercinetosis is a symptom similar to motion sickness that occurs with exposure to a virtual environment, will be assessed using a 3-level Likert scale (light-moderate-severe)
    Time Frame
    Just after the procedure
    Title
    Pain catastrophizing
    Description
    Pain catastrophizing will be assessed using the French version of the Situational Catastrophizing Questionnaire, a 6-question adaptation of the Pain Catastrophizing Scale
    Time Frame
    Just before the procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged ≥18 ; Patient requiring one of the following treatment procedures : suturing, plaster cast placement and/or repositioning, fracture or dislocation reduction, ascites puncture, pleural puncture, lumbar puncture. Exclusion Criteria: Patient clinically unstable; Patient incapable of discernment or consent ; Altered mental status (cognitive disorders, mental retardation, acute state of confusion, acute psychosis); Alcoholic patient with University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) score of 10/10 ; Patient hard of hearing ; Patient with visual impairments preventing him/her from perceiving his/her environment ; Patient unable to understand the use of visual analog scales (VAS); Impaired sensitivity of the part of the body where the medical intervention is to take place; Planned use of analgesia/sedation with a dissociative agent (midazolam, ketamine, propofol); Incarcerated patient ; Patient transferred from another hospital ; Patient having already participated in this study during a previous consultation in the emergency department of the Centre Hospitalier Universitaire Vaudois.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pr. Olivier Hugli, MPH
    Phone
    21 314 05
    Ext
    +41
    Email
    Olivier.Hugli@chuv.ch
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pr. Chantal Berna Renella, MD PHD
    Phone
    21 314 20 40
    Ext
    +41
    Email
    Chantal.Berna-Renella@chuv.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Olivier Hugli, MD
    Organizational Affiliation
    University of Lausanne Hospitals
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Atmospheric Projection in the Emergency Department

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