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Clinical Trials/NCT05967988
NCT05967988
Terminated
N/A

AtmosphEric pRojection for paIn and Anxiety reLated to Minor Medical Procedures in the Emergency Department: a Monocentric, Parallel, Randomized, Controlled Study

University of Lausanne Hospitals1 site in 1 country62 target enrollmentAugust 14, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
University of Lausanne Hospitals
Enrollment
62
Locations
1
Primary Endpoint
Procedural Anxiety
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 14, 2023
End Date
April 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Lausanne Hospitals
Responsible Party
Principal Investigator
Principal Investigator

Olivier Hugli

Head of Emergency Department

University of Lausanne Hospitals

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 ;

Outcomes

Primary Outcomes

Procedural Anxiety

Time Frame: 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."

Procedural Pain

Time Frame: 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"

Secondary Outcomes

  • Cybercinetosis(Just after the procedure)
  • Appreciation of the atmospheric projection(Just after the procedure)
  • Dissociation(Just after the procedure)
  • Patient's comfort(Just after the procedure)
  • Telepresence(Just after the procedure)
  • Procedural support(After the procedure)
  • Procedural disturbance(Just after the procedure)
  • Pain catastrophizing(Just before the procedure)

Study Sites (1)

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