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AERIAL-MED: Atmospheric Projection in the Emergency Department

Sponsor
University of Lausanne Hospitals (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05967988
Collaborator
University of Lausanne (Other)
140
Enrollment
2
Arms
12.6
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Immersive atmospheric projection
  • Device: Minimal atmospheric projection
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
The patient will assess the outcome him/herself. The statistician will also be blinded to the group assignment.
Primary Purpose:
Treatment
Official Title:
AtmosphEric pRojection for paIn and Anxiety reLated to Minor Medical Procedures in the Emergency Department: a Monocentric, Parallel, Randomized, Controlled Study
Anticipated Study Start Date :
Aug 14, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Atmospheric 3D video projection

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

Device: Immersive atmospheric projection
Projection of computer-generated videos or videos of real moving landscapes on the walls of the examination room
Sham Comparator: Atmospheric 3D color projection

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

Device: Minimal atmospheric projection
Projection of a colors on the walls on the walls of the examination room

Outcome Measures

Primary Outcome Measures

  1. Procedural Pain [Just after the procedure]

    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"

  2. Procedural Anxiety [Just after the procedure]

    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

  1. Telepresence [Just after the procedure]

    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

  2. Dissociation [Just after the procedure]

    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 "

  3. Appreciation of the atmospheric projection [Just after the procedure]

    Appreciation of the atmospheric projection by the patient, using a Visual Analogic Scale from 0mm to 100mm, anchored with "least appreciative/most appreciative)

  4. Patient's comfort [Just after the procedure]

    Patient's comfort during the atmospheric projection, assessed using a Visual Analogic Scale from 0mm to 100mm, anchored with "least comfortable /most comfortable"

  5. Procedural support [After the procedure]

    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)

  6. Procedural disturbance [Just after the procedure]

    Procedural disturbance for physicians caused by the atmospheric projection interfering with the medical procedure, assessed using a 3-level Likert scale (yes-neutral-no)

  7. Cybercinetosis [Just after the procedure]

    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)

  8. Pain catastrophizing [Just before the procedure]

    Pain catastrophizing will be assessed using the French version of the Situational Catastrophizing Questionnaire, a 6-question adaptation of the Pain Catastrophizing Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Lausanne Hospitals
  • University of Lausanne

Investigators

  • Principal Investigator: Olivier Hugli, MD, University of Lausanne Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olivier Hugli, Head of Emergency Department, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT05967988
Other Study ID Numbers:
  • CER-VD 2023-00867
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Emergencies
Acute Pain

Study Results

No Results Posted as of Aug 1, 2023