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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05967988
Other study ID # CER-VD 2023-00867
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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