Clinical trial NCT05967988: Atmospheric Projection in the Emergency Department
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
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Acute
Anxiety Acute
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: University of Lausanne
First posted: 2023-08-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Procedural Pain
timeFrame: Just after the procedure
measure: Procedural Anxiety
timeFrame: Just after the procedure
Secondary outcomes:
measure: Telepresence
timeFrame: Just after the procedure
measure: Dissociation
timeFrame: Just after the procedure
measure: Appreciation of the atmospheric projection
timeFrame: Just after the procedure
measure: Patient's comfort
timeFrame: Just after the procedure
measure: Procedural support
timeFrame: After the procedure
measure: Procedural disturbance
timeFrame: Just after the procedure
measure: Cybercinetosis
timeFrame: Just after the procedure
measure: Pain catastrophizing
timeFrame: Just before the procedure
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: Olivier Hugli, MD
role: PRINCIPAL_INVESTIGATOR
References: