AnxietyREVDOUNCT04731792
Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.
A study testing Virtual Reality in people with Anxiety and Stress, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
Marie Lannelongue Hospital is a hospital specialized in lung transplantation. Lung transplant patients require regular check-ups by bronchial fibroscopy. This examination is known to be anxious, stressful and sometimes painful. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2021to 14 Feb 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
- Patient with a lung or cardio-pulmonary transplant
- Adults (age > 18 years old)
- Patient who give their informed consent for the protocol
- Patient requiring a bronchial fibroscopy and having already had at least one - bronchial fibroscopy without virtual reality
Who cannot join
- children
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350
cecile Degoulet, 01.40.94.25.98, c.degoulet@ghpsj.fr
About this study
Marie Lannelongue Hospital is a hospital specialized in lung transplantation. Lung transplant patients require regular check-ups by bronchial fibroscopy. This examination is known to be anxious, stressful and sometimes painful. These patients take many medications (immunosuppressants, antibiotics....) that may interact with analgesic or anxiolytic drugs.
The objective is to propose to HML lung transplant patients a virtual reality solution containing visual and auditory 3D experiences to fight against anxiety and pain during repetitive and anxiogenic examinations such as bronchial fibroscopies.
Translated with www.DeepL.com/Translator (free version)
- Conditions
- Anxiety, Stress, Pain, Bronchial Fibroscopy, Pulmonary Transplantation
- Being tested
- Virtual Reality
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
a bronchial fibroscopy with a virtual reality helmet
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality group | Experimental | Not described Receives: Other: Virtual Reality |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogic Scale (VAS) score from 0 (no anxiety) to 10 (terrified).
Measured: 1 day
Secondary outcomes (1)
Evaluation of pain by a score on a numerical scale (EN) from 0 (no pain) to 10 (unbearable pain)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start14 Jan 2021
- Primary completion14 Jan 2024 (estimated)
- Study completion14 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731792
- Sponsor's protocol ID
- 2020-A00658-31
- Acronym
- REVDOU
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 1 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.
- ClinicalTrials.gov ID
- NCT04731792
- Acronym / sponsor ID
- REVDOU / 2020-A00658-31
- Conditions
- Anxiety, Stress, Pain, Bronchial Fibroscopy, Pulmonary Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 14 Jan 2024 (estimated)
- Study completion
- 14 Feb 2024 (estimated)
- First posted
- 1 Feb 2021 (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.
Marie Lannelongue Hospital is a hospital specialized in lung transplantation. Lung transplant patients require regular check-ups by bronchial fibroscopy. This examination is known to be anxious, stressful and sometimes painful. These patients take many medications (immunosuppressants, antibiotics....) that may interact with analgesic or anxiolytic drugs.
The objective is to propose to HML lung transplant patients a virtual reality solution containing visual and auditory 3D experiences to fight against anxiety and pain during repetitive and anxiogenic examinations such as bronchial fibroscopies.
Translated with www.DeepL.com/Translator (free version)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality group | Experimental | Other: Virtual Reality |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with a lung or cardio-pulmonary transplant
- Adults (age > 18 years old)
- Patient who give their informed consent for the protocol
- Patient requiring a bronchial fibroscopy and having already had at least one - bronchial fibroscopy without virtual reality
Key exclusion criteria (1 listed)
- children
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 |
|---|---|---|
| Virtual Realitya bronchial fibroscopy with a virtual reality helmet | Other | Virtual Reality group |
Primary outcome
Visual Analogic Scale (VAS) score from 0 (no anxiety) to 10 (terrified).
Time frame: 1 day
1 secondary outcome
Evaluation of pain by a score on a numerical scale (EN) from 0 (no pain) to 10 (unbearable pain)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Anxiety and Stress, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Feb 2021. 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 France. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cécile DEGOULET (01 40 94 25 98, c.degoulet@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogic Scale (VAS) score from 0 (no anxiety) to 10 (terrified). (time frame: 1 day). 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 1 Feb 2021.