Pain and AnxietyVRNCT06425835
Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments
An observational study of Pain and Anxiety and Dislocation, run by University of Monastir.
Trial summary
Study and evaluate the effectiveness of virtual reality in pain management. Read more about this study
- Who is it for?
- Ages 9 to 24 years
- Conditions the study is for
- Pain and Anxiety, Dislocation, Suture
- What is being tested?
- VR device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 15 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 9 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned. * If initial VAS >5 and intolerable: patients will immediately use painkillers and will be excluded from the study. * If initial VAS<=5 or > 5 but tolerable: Only VR glasses are used as an analgesic.
Who may be able to join
- Patients aged 09 and 24 years
- suturing a wound
- changing a dressing
- lumbar puncture,
- peripheral venous line
- blood test
Show all 9Show fewer
- intramuscular injection
- reduction of a fracture
- casting or plastering.
Who cannot join
- impaired consciousness
- epilepsy
- wound/infection covering the helmet area
- headache
- intellectual/mental retardation
- nausea, vomiting
- patient already included in the protocol
- pain requiring immediate medical attention. analgesic (VAS >5 and described as intolerable).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments: (Open Prospective Observational Study)
Study and evaluate the effectiveness of virtual reality in pain management.
Read the detailed description
Study and evaluate the effectiveness of virtual reality in pain management.This is an open prospective observational study carried out at Urgences Fattouma Bourgiba Monastir.
For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned.
- If initial VAS >5 and intolerable: patients will immediately use painkillers and will be excluded from the study.
- If initial VAS <=5 or > 5 but tolerable: Only VR glasses are used as an analgesic.
If during the procedure the patient describes intolerable pain: the VAS will be noted, and the patient will use a rescue analgesic (intranasal ketamine or other at the discretion of the attending physician).
The VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol.
The first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care.
The intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted.
- Conditions
- Pain and Anxiety, Dislocation, Suture
- Being tested
- VR device
- Medical subject headings
- Pain, Anxiety Disorders, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR deviceOther
The VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol.
The first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care.
The intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted.
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of success
frequency of success (%) (use of emergency analgesics)
Measured: 30 minutes
Secondary outcomes (1)
reduction of pain
reduction in pain assessed by the visual analog scale (mm)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain and AnxietyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425835
- Sponsor's protocol ID
- UMonastir2024
- Acronym
- VR
- Status last verified
- May 2024
- First submitted
- 14 Mar 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments: (Open Prospective Observational Study)
- ClinicalTrials.gov ID
- NCT06425835
- Acronym / sponsor ID
- VR / UMonastir2024
- Conditions
- Pain and Anxiety, Dislocation, Suture
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 22 May 2024 (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.
Study and evaluate the effectiveness of virtual reality in pain management.
Detailed description
Study and evaluate the effectiveness of virtual reality in pain management.This is an open prospective observational study carried out at Urgences Fattouma Bourgiba Monastir.
For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned.
- If initial VAS >5 and intolerable: patients will immediately use painkillers and will be excluded from the study.
- If initial VAS <=5 or > 5 but tolerable: Only VR glasses are used as an analgesic.
If during the procedure the patient describes intolerable pain: the VAS will be noted, and the patient will use a rescue analgesic (intranasal ketamine or other at the discretion of the attending physician).
The VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol.
The first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care.
The intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 9 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned. * If initial VAS >5 and intolerable: patients will immediately use painkillers and will be excluded from the study. * If initial VAS<=5 or > 5 but tolerable: Only VR glasses are used as an analgesic.
Key inclusion criteria (9 listed)
- Patients aged 09 and 24 years
- suturing a wound
- changing a dressing
- lumbar puncture,
- peripheral venous line
Key exclusion criteria (8 listed)
- impaired consciousness
- epilepsy
- wound/infection covering the helmet area
- headache
- intellectual/mental retardation
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 |
|---|---|---|
| VR deviceThe VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol. The first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care. The intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted. | Other | – |
Primary outcome
frequency of success
Time frame: 30 minutes
frequency of success (%) (use of emergency analgesics)
1 secondary outcome
reduction of pain
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Anxiety and Dislocation, run by University of Monastir.
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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NOUIRA Semir, PR (73106000 ext. 216, semir.nouira@rns.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of success (time frame: 30 minutes). 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 22 May 2024.