NCT05967988

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

August 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

June 28, 2023

Last Update Submit

April 11, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (8)

  • Telepresence

    Just after the procedure

  • Dissociation

    Just after the procedure

  • Appreciation of the atmospheric projection

    Just after the procedure

  • Patient's comfort

    Just after the procedure

  • Procedural support

    After the procedure

  • +3 more secondary outcomes

Study Arms (2)

Atmospheric 3D video projection

EXPERIMENTAL

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

Device: Immersive atmospheric projection

Atmospheric 3D color projection

SHAM COMPARATOR

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

Interventions

Projection of computer-generated videos or videos of real moving landscapes on the walls of the examination room

Atmospheric 3D video projection

Projection of a colors on the walls on the walls of the examination room

Atmospheric 3D color projection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1012, Switzerland

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Hugli, MD

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patient will assess the outcome him/herself. The statistician will also be blinded to the group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Emergency Department

Study Record Dates

First Submitted

June 28, 2023

First Posted

August 1, 2023

Study Start

August 14, 2023

Primary Completion

October 11, 2023

Study Completion

April 30, 2024

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations