Atmospheric Projection in the Emergency Department

Pain, Acute Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05967988
• Other study ID #: CER-VD 2023-00867
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2023
• Source: University of Lausanne Hospitals
• Contact: Pr. Olivier Hugli, MPH
• Phone: 21 314 05
• Email: Olivier.Hugli[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: August 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Anxiety Acute
• Emergencies
• Pain, Acute

Intervention

Device:
• Immersive atmospheric projection
Projection of computer-generated videos or videos of real moving landscapes on the walls of the examination room
• Minimal atmospheric projection
Projection of a colors on the walls on the walls of the examination room

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne Hospitals	University of Lausanne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	Just after the procedure
Primary	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."	Just after the procedure
Secondary	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	Just after the procedure
Secondary	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 "	Just after the procedure
Secondary	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)	Just after the procedure
Secondary	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"	Just after the procedure
Secondary	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)	After the procedure
Secondary	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)	Just after the procedure
Secondary	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)	Just after the procedure
Secondary	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	Just before the procedure