Pain, AcuteAERIAL-MEDNCT05967988
Atmospheric Projection in the Emergency Department
A study testing Immersive atmospheric projection and Minimal atmospheric projection in people with Pain, Acute and Anxiety Acute, run by University of Lausanne Hospitals at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute, Anxiety Acute
- What is being tested?
- Immersive atmospheric projection and Minimal atmospheric projection
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Aug 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 ;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lausanne University Hospital
Lausanne, Canton of Vaud, 1012
About this study
Official title: AtmosphEric pRojection for paIn and Anxiety reLated to Minor Medical Procedures in the Emergency Department: a Monocentric, Parallel, Randomized, Controlled Study
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.
- Conditions
- Pain, Acute, Anxiety Acute
- Being tested
- Immersive atmospheric projection, Minimal atmospheric projection
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive atmospheric projectionDevice
Projection of computer-generated videos or videos of real moving landscapes on the walls of the examination room
Minimal atmospheric projectionDevice
Projection of a colors on the walls on the walls of the examination room
| Study group | Role | What they receive |
|---|---|---|
| Atmospheric 3D video projection | Experimental | Patients in the interventional arm will watch an immersive atmospheric video projection on the walls of their examination room. Receives: 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. Receives: Device: Minimal atmospheric projection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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."
Measured: Just after the procedure
Secondary outcomes (8)
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
Measured: Just after the procedure
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 "
Measured: Just after the procedure
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)
Measured: Just after the procedure
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"
Measured: Just after the procedure
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)
Measured: After the procedure
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)
Measured: Just after the procedure
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)
Measured: Just after the procedure
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
Measured: Just before the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start14 Aug 2023
- Primary completion11 Oct 2023
- Study completion30 Apr 2024
Why it stopped: lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne
- Responsible party
- Principal investigator, Olivier Hugli, University of Lausanne Hospitals
- Investigators
- Olivier Hugli, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967988
- Sponsor's protocol ID
- CER-VD 2023-00867
- Acronym
- AERIAL-MED
- Status last verified
- Apr 2025
- First submitted
- 28 Jun 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AtmosphEric pRojection for paIn and Anxiety reLated to Minor Medical Procedures in the Emergency Department: a Monocentric, Parallel, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05967988
- Acronym / sponsor ID
- AERIAL-MED / CER-VD 2023-00867
- Conditions
- Pain, Acute, Anxiety Acute
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of resources
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- University of Lausanne
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atmospheric 3D video projection | Experimental | Device: Immersive atmospheric projectionPatients in the interventional arm will watch an immersive atmospheric video projection on the walls of their examination room. |
| Atmospheric 3D color projection | Sham comparator | Device: Minimal atmospheric projectionPatients in the interventional arm will look at a neutral color of their choice projected on the walls of their examination room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive atmospheric projectionProjection of computer-generated videos or videos of real moving landscapes on the walls of the examination room | Device | Atmospheric 3D video projection |
| Minimal atmospheric projectionProjection of a colors on the walls on the walls of the examination room | Device | Atmospheric 3D color projection |
Primary outcome
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"
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."
8 secondary outcomes
Telepresence
Time frame: Just after the procedure
Dissociation
Time frame: Just after the procedure
Appreciation of the atmospheric projection
Time frame: Just after the procedure
Patient's comfort
Time frame: Just after the procedure
Procedural support
Time frame: After the procedure
Procedural disturbance
Time frame: Just after the procedure
Cybercinetosis
Time frame: Just after the procedure
Pain catastrophizing
Time frame: Just before the procedure
Results and safety
The study was stopped early (reason given: lack of resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Pain, Acute
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Hugli, MD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive atmospheric projection and Minimal atmospheric projection in people with Pain, Acute and Anxiety Acute, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of resources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Pain (time frame: Just after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.