PneumopathyVeRHiTYNCT04478253
Virtual Reality Hypnosis for Thoracic Drain Insertion
A study testing HypnoVR in people with Pneumopathy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The main objective of this study is to evaluate, in vigilant resuscitation patients, the effect of the use of HYPNO VR on the pain felt during the insertion of a thoracic drain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumopathy
- What is being tested?
- HypnoVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2020to 29 Sep 2023
- 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 18 years of age or older, having read and signed the consent form for participation in the study
- Patient admitted to intensive care whose state of health requires the insertion of a thoracic drain according to the doctor in charge of the patient.
Who cannot join
- Patient under legal protection, guardianship or trusteeship
- Pregnant or breastfeeding patient
- Patient not affiliated to the French social security system
- Hearing or visual disturbances contraindicating the use of virtual reality headphones
- Inability to provide the subject with informed information and/or written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient
- Unbalanced epilepsy
Show all 9Show fewer
- Contraindication to local anaesthesia, one of the analgesics or sleeping pills used in the protocol
- Need for drainage in a life-threatening emergency (respiratory distress or compressive pleural effusion)
- Concurrent participation in other research or during a period of exclusion from previous research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Use of HYPNO VR on Pain Experienced During Chest Drain Insertion in Resuscitation Vigilant Patients.
The main objective of this study is to evaluate, in vigilant resuscitation patients, the effect of the use of HYPNO VR on the pain felt during the insertion of a thoracic drain.
Read the detailed description
This is a prospective, randomized, open-label, monocentric, prospective study of two parallel groups of patients in whom a chest tube is to be inserted:
- Group 1: Insertion of the drain according to the usual management protocol.
- Group 2: Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).
- Conditions
- Pneumopathy
- Being tested
- HypnoVR
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnoVRDevice
Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).
| Study group | Role | What they receive |
|---|---|---|
| HypnoVR | Experimental | Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR). Receives: Device: HypnoVR |
| Usual care | No intervention | Insertion of the drain according to the usual management protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity progression
The intensity of pain associated with chest drain insertion (difference between pain felt at the time of insertion and basal pain prior to the procedure) is the primary endpoint. This will be measured on a simple numerical scale Graduated from 0 (no pain) to 10 (worst pain imaginable). Basal pain will be assessed 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h.
Measured: 24 hours
Secondary outcomes (5)
Evolution of pain measured on a simple numerical scale over 24 hours
Evolution of pain over 24 hours measured on a simple numerical scale Graduated from 0 (no pain) to 10 (worst pain imaginable). Basal pain will be assessed 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h.
Measured: 24 hours
Pain distress measured on a simple numerical scale during the procedure and evolution from basal state
Pain distress during the procedure and evolution from basal state. The patient will rate how much pain during the procedure was distressing or annoying on a simple numerical scale ranging from 0 (not at all) to 10 (very annoying or upsetting). It will be evaluated in the basal state 15 min before drainage, then immediately after insertion and after 24 hours.
Measured: 24 hours
Anxiety level measured on a simple numerical scale and the State-trait Anxiety Inventory scale (STAI-Y scale) during the procedure and evolution from basal status
Anxiety level measured on a simple numerical scale graduated from 0 (no anxiety) to 10 (worst imaginable anxiety) and the State-trait Anxiety Inventory scale (STAI-Y scale) during the procedure and evolution from basal status. The simple numerical scale graded from 0 (no anxiety) to 10 (worst imaginable anxiety) will be evaluated in the basal state 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h. The STAI-Y scale has 20 items evaluated from 1 to 4 according to its intensity (1= NO, 2 = rather NO, 3 = rather YES, 4 = YES) will be evaluated in the basal state 15 min before drainage then immediately after insertion and after 24 hours.
Measured: 24 hours
Evaluation of sleep quality simple numerical scale graduated from 0 (very bad) to 10 (very good) on the first night after insertion of the drain and evolution compared to usual sleep quality.
Evaluation of sleep quality measured on a simple numerical scale graduated from 0 (very bad) to 10 (very good) on the first night after insertion of the drain and evolution compared to usual sleep quality.
Measured: 24 hours
Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.
Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start23 May 2020
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumopathyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective monocentric open-label study on two parallel groups based on the use or non-use of a virtual reality device coupled with hypnosis software (HYPNO-VR) during the insertion of a chest tube.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud GALBOIS, MD, Principal investigator, Hôpital Privé Claude Galien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478253
- Sponsor's protocol ID
- 2019-A02677-50
- Acronym
- VeRHiTY
- Status last verified
- Jun 2024
- First submitted
- 2 Jul 2020
- Last updated
- 1 Jul 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of HYPNO VR on Pain Experienced During Chest Drain Insertion in Resuscitation Vigilant Patients.
- ClinicalTrials.gov ID
- NCT04478253
- Acronym / sponsor ID
- VeRHiTY / 2019-A02677-50
- Conditions
- Pneumopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 23 May 2020 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 20 Jul 2020 (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 main objective of this study is to evaluate, in vigilant resuscitation patients, the effect of the use of HYPNO VR on the pain felt during the insertion of a thoracic drain.
Detailed description
This is a prospective, randomized, open-label, monocentric, prospective study of two parallel groups of patients in whom a chest tube is to be inserted:
- Group 1: Insertion of the drain according to the usual management protocol.
- Group 2: Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized prospective monocentric open-label study on two parallel groups based on the use or non-use of a virtual reality device coupled with hypnosis software (HYPNO-VR) during the insertion of a chest tube.
| Arm | Type | Receives |
|---|---|---|
| HypnoVR | Experimental | Device: HypnoVRInsertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR). |
| Usual care | No intervention | –Insertion of the drain according to the usual management protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient 18 years of age or older, having read and signed the consent form for participation in the study
- Patient admitted to intensive care whose state of health requires the insertion of a thoracic drain according to the doctor in charge of the patient.
Key exclusion criteria (9 listed)
- Patient under legal protection, guardianship or trusteeship
- Pregnant or breastfeeding patient
- Patient not affiliated to the French social security system
- Hearing or visual disturbances contraindicating the use of virtual reality headphones
- Inability to provide the subject with informed information and/or written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient
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 |
|---|---|---|
| HypnoVRInsertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR). | Device | HypnoVR |
Primary outcome
Pain intensity progression
Time frame: 24 hours
The intensity of pain associated with chest drain insertion (difference between pain felt at the time of insertion and basal pain prior to the procedure) is the primary endpoint. This will be measured on a simple numerical scale Graduated from 0 (no pain) to 10 (worst pain imaginable). Basal pain will be assessed 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h.
5 secondary outcomes
Evolution of pain measured on a simple numerical scale over 24 hours
Time frame: 24 hours
Pain distress measured on a simple numerical scale during the procedure and evolution from basal state
Time frame: 24 hours
Anxiety level measured on a simple numerical scale and the State-trait Anxiety Inventory scale (STAI-Y scale) during the procedure and evolution from basal status
Time frame: 24 hours
Evaluation of sleep quality simple numerical scale graduated from 0 (very bad) to 10 (very good) on the first night after insertion of the drain and evolution compared to usual sleep quality.
Time frame: 24 hours
Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 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. This study is not recruiting at the moment.
Arnaud GALBOIS, MD principal investigator
Hôpital Privé Claude Galien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HypnoVR in people with Pneumopathy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 1 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain intensity progression (time frame: 24 hours). 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 Jul 2024.