Sickle Cell DiseaseDREPAReVNCT04917120
Observational Prospective Study Measuring the Impact of the Use of a Hypnotic Script Associated With Virtual Reality on the Pain of the Child's Sickle Cell During a Vaso-occlusive Crisis
A study testing Virtual Reality in people with Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the effect of Virtual Reality induced Hypnosis on patients' pain scores, anxiety and the use of analgesics during a vaso-occlusive crisis Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2021to 19 Jul 2022
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Child over 6 years of age on the day of acceptance of the study (no upper limit)
- Suffering from sickle cell disease whatever genotype
- Admission in hospital for a VOC (vaso-occlusive crisis)
- Informed and signed consent by at least one legal guardian, if child is minor, and verbal agreement of the child himself.
Who cannot join
- Deaf patient, visually impaired patient, claustrophobic and/or aquaphobic patient
- Patient not understanding French
- History of psychiatric illness such as paranoia, schizophrenia, manic-depressive psychosis, high suicide risk patient.
- The patient may be included several times in the study if he is hospitalized again during the inclusion period.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effect of Virtual Reality induced Hypnosis on patients' pain scores, anxiety and the use of analgesics during a vaso-occlusive crisis
Read the detailed description
Virtual reality hypnosis could probably reduce vaso-occlusive crisis-related (vaso-occlusive crisis) anxiety and pain and provide the patient with means of optimizing the ability to cope with the painful and anxiety-provoking situations encountered in general pediatric unit.
However, this non-pharmacological analgesic technique is little used in the context of vaso-occlusive crisis in children and adolescents in French pediatric services.
Currently, the average pain scores of children and adolescents hospitalized for vaso-occlusive crisis after treatment in the emergency department is 6 out of 10 on a simple numerical scale (according to a preliminary study conducted on 30 files of sickle cell disease patients over 6 years of age hospitalized in general pediatrics, Trousseau AP-HP hospital over a period of 6 months in 2018), despite the implementation of optimal pharmacological means with regard to the HAS analgesia recommendations. The pain score stays high despite a well-conducted analgesic treatment.
Our hypothesis is that virtual reality hypnosis could potentiate the effects of virtual reality by hypnotic suggestions specific to the pain of patients with vaso-occlusive crisis . This is a pain and anxiety reduction strategy that has, to our knowledge, never been evaluated.
So this is innovative by the method but also of the pediatric target population suffering from recurrent and severe pain.
A session of hypnoanalgesia suggestions associated with a virtual reality program will allow the patient to acquire the necessary competence to manage with his or her pain and thus be more autonomous in its management.
The physiopathological hypothesis of the research is that the immersion of the patient with vaso-occlusive crises related pain during a hypnotic experience induced by virtual reality allows to saturate his sensoriality, thus reducing nociceptive perceptions and vaso-occlusive crisis -related anxiety. We hypothesize that this experiment is feasible and that it can produce decrease in pain and anxiety scores for children benefiting from a virtual reality hypnosis session during vaso-occlusive crisis within one hour of session.
- Conditions
- Sickle Cell Disease
- Being tested
- Virtual Reality
- Keywords
- Sickle cell disease, Pain, Virtual reality, Vaso occlusive crises, Hypnosis
- Medical subject headings
- Anemia, Sickle Cell, Pain, Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
The procedure will consist of a virtual reality program associated with suggestions of hypnoanalgesia, be added to usual care. Included patients will benefit from the Virtual Reality program combined with hypnoanalgesia suggestions for a period of 20 minutes. We will use a helmet with a built-in screen and an audio headset connected to a control room. Patients will watch an Virtual Reality sequence while listening to narratives designed for the hypnoanalgesia of the present pain.
| Study group | Role | What they receive |
|---|---|---|
| VRH (virtual reality hypnosis) | Experimental | Not described Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessment with score (patient)
Measuring pain thanks to score pain by the patient 3 hours after a Virtual Reality session performed within the first 6 hours after arrival in the general pediatrics unit Patients will use le Faces Pain Scale - Revised.
Measured: hours 3 after a virtual reality
Secondary outcomes (10)
pain assessment with score (patient)
Measuring pain thanks to score pain by the patient 10 minutes before the Virtual Reality session performed within the first 6 hours after arrival in the general pediatrics unit Patients will use le Faces Pain Scale - Revised.
Measured: 10 minutes before HVR
pain assessment with score (patient)
Measuring pain thanks to score pain by the patient 1 hour after a Virtual Reality session performed within the first 6 hours after arrival in the general pediatrics unit Patients will use le Faces Pain Scale - Revised.
Measured: 1 hour after a virtual reality
pain assessment with score (health care personnel)
Measuring pain thanks to score pain by the health care personnel 10 minutes before the Virtual Reality session performed within the first 6 hours after arrival in the general pediatrics unit Health care personnel will use EVENDOL score (score between " 0 " corresponding to " no pain sign " and " 15 " corresponding to " maximum pain signs ").
Measured: 10 minutes before HVR
pain assessment with score (health care personnel)
Measuring pain thanks to score pain by the health care personnel 1 hour after a Virtual Reality session performed within the first 6 hours after arrival in the general pediatrics unit Health care personnel will use EVENDOL score (score between " 0 " corresponding to " no pain sign " and " 15 " corresponding to " maximum pain signs ").
Measured: 1 hour after a virtual reality
pain assessment with score (health care personnel)
Measuring pain thanks to score pain by the health care personnel 3 hours after a Virtual Reality session performed within the first 6 hours after arrival in the general pediatrics unit Health care personnel will use EVENDOL score (score between " 0 " corresponding to " no pain sign " and " 15 " corresponding to " maximum pain signs ").
Measured: 3 hour after a virtual reality
anxiety assessment
To assess efficacy on anxiety 10 minutes before the session, we will use a numerical scale graduated from 0 to 10 (" 0 " corresponding to " no anxiety " and " 10 " corresponding to " maximum anxiety ")
Measured: 10 minutes before HVR
anxiety assessment
To assess efficacy on anxiety 1 hour after the session, we will use a numerical scale graduated from 0 to 10 (" 0 " corresponding to " no anxiety " and " 10 " corresponding to " maximum anxiety ")
Measured: 1 hour after HVR
anxiety assessment
To assess efficacy on anxiety 3 hours after the session, we will use a numerical scale graduated from 0 to 10 (" 0 " corresponding to " no anxiety " and " 10 " corresponding to " maximum anxiety ")
Measured: 3 hour after HVR
patient satisfaction assessment
We will use the Likert scale 3 hours after the session (" 0 " corresponding to " no satisfaction " and " 5 " corresponding to " complete satisfaction "
Measured: 3 hour
health care personnel satisfaction assessment
We will use the Likert scale 3 hours after the session (" 0 " corresponding to " no satisfaction " and " 5 " corresponding to " complete satisfaction "
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start13 Jul 2021
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie DUGUE, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917120
- Sponsor's protocol ID
- APHP201280
- Other IDs
- IDRCB2020-AO2248-31
- Acronym
- DREPAReV
- Status last verified
- May 2025
- First submitted
- 10 May 2021
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study Measuring the Impact of the Use of a Hypnotic Script Associated With Virtual Reality on the Pain of the Child's Sickle Cell During a Vaso-occlusive Crisis
- ClinicalTrials.gov ID
- NCT04917120
- Acronym / sponsor ID
- DREPAReV / APHP201280
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle cell disease, Pain, Virtual reality, Vaso occlusive crises, Hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 8 Jun 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.
The purpose of this study is to evaluate the effect of Virtual Reality induced Hypnosis on patients' pain scores, anxiety and the use of analgesics during a vaso-occlusive crisis
Detailed description
Virtual reality hypnosis could probably reduce vaso-occlusive crisis-related (vaso-occlusive crisis) anxiety and pain and provide the patient with means of optimizing the ability to cope with the painful and anxiety-provoking situations encountered in general pediatric unit.
However, this non-pharmacological analgesic technique is little used in the context of vaso-occlusive crisis in children and adolescents in French pediatric services.
Currently, the average pain scores of children and adolescents hospitalized for vaso-occlusive crisis after treatment in the emergency department is 6 out of 10 on a simple numerical scale (according to a preliminary study conducted on 30 files of sickle cell disease patients over 6 years of age hospitalized in general pediatrics, Trousseau AP-HP hospital over a period of 6 months in 2018), despite the implementation of optimal pharmacological means with regard to the HAS analgesia recommendations. The pain score stays high despite a well-conducted analgesic treatment.
Our hypothesis is that virtual reality hypnosis could potentiate the effects of virtual reality by hypnotic suggestions specific to the pain of patients with vaso-occlusive crisis . This is a pain and anxiety reduction strategy that has, to our knowledge, never been evaluated.
So this is innovative by the method but also of the pediatric target population suffering from recurrent and severe pain.
A session of hypnoanalgesia suggestions associated with a virtual reality program will allow the patient to acquire the necessary competence to manage with his or her pain and thus be more autonomous in its management.
The physiopathological hypothesis of the research is that the immersion of the patient with vaso-occlusive crises related pain during a hypnotic experience induced by virtual reality allows to saturate his sensoriality, thus reducing nociceptive perceptions and vaso-occlusive crisis -related anxiety. We hypothesize that this experiment is feasible and that it can produce decrease in pain and anxiety scores for children benefiting from a virtual reality hypnosis session during vaso-occlusive crisis within one hour of session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VRH (virtual reality hypnosis) | Experimental | Device: Virtual Reality |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Child over 6 years of age on the day of acceptance of the study (no upper limit)
- Suffering from sickle cell disease whatever genotype
- Admission in hospital for a VOC (vaso-occlusive crisis)
- Informed and signed consent by at least one legal guardian, if child is minor, and verbal agreement of the child himself.
Key exclusion criteria (4 listed)
- Deaf patient, visually impaired patient, claustrophobic and/or aquaphobic patient
- Patient not understanding French
- History of psychiatric illness such as paranoia, schizophrenia, manic-depressive psychosis, high suicide risk patient.
- The patient may be included several times in the study if he is hospitalized again during the inclusion period.
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 RealityThe procedure will consist of a virtual reality program associated with suggestions of hypnoanalgesia, be added to usual care. Included patients will benefit from the Virtual Reality program combined with hypnoanalgesia suggestions for a period of 20 minutes. We will use a helmet with a built-in screen and an audio headset connected to a control room. Patients will watch an Virtual Reality sequence while listening to narratives designed for the hypnoanalgesia of the present pain. | Device | VRH (virtual reality hypnosis) |
Primary outcome
pain assessment with score (patient)
Time frame: hours 3 after a virtual reality
Measuring pain thanks to score pain by the patient 3 hours after a Virtual Reality session performed within the first 6 hours after arrival in the general pediatrics unit Patients will use le Faces Pain Scale - Revised.
10 secondary outcomes
pain assessment with score (patient)
Time frame: 10 minutes before HVR
pain assessment with score (patient)
Time frame: 1 hour after a virtual reality
pain assessment with score (health care personnel)
Time frame: 10 minutes before HVR
pain assessment with score (health care personnel)
Time frame: 1 hour after a virtual reality
pain assessment with score (health care personnel)
Time frame: 3 hour after a virtual reality
anxiety assessment
Time frame: 10 minutes before HVR
anxiety assessment
Time frame: 1 hour after HVR
anxiety assessment
Time frame: 3 hour after HVR
patient satisfaction assessment
Time frame: 3 hour
health care personnel satisfaction assessment
Time frame: 5 months
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 16 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Sophie DUGUE study chair
Assistance Publique - Hôpitaux de Paris
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 Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris 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 4 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 16 Sep 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 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 assessment with score (patient) (time frame: hours 3 after a virtual reality). 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 Sep 2025.