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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 (DREPAReV)

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ClinicalTrials.gov Identifier: NCT04917120
Recruitment Status : Recruiting
First Posted : June 8, 2021
Last Update Posted : October 18, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Device: Virtual Reality Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : July 13, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VRH (virtual reality hypnosis) Device: Virtual Reality
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. pain assessment with score (patient) [ Time Frame: 10 minutes before HVR ]
    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.

  2. pain assessment with score (patient) [ Time Frame: 1 hour after a virtual reality ]
    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.

  3. pain assessment with score (health care personnel) [ Time Frame: 10 minutes before HVR ]
    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 ").

  4. pain assessment with score (health care personnel) [ Time Frame: 1 hour after a virtual reality ]
    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 ").

  5. pain assessment with score (health care personnel) [ Time Frame: 3 hour after a virtual reality ]
    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 ").

  6. anxiety assessment [ Time Frame: 10 minutes before HVR ]
    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 ")

  7. anxiety assessment [ Time Frame: 1 hour after HVR ]
    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 ")

  8. anxiety assessment [ Time Frame: 3 hour after HVR ]
    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 ")

  9. patient satisfaction assessment [ Time Frame: 3 hour ]
    We will use the Likert scale 3 hours after the session (" 0 " corresponding to " no satisfaction " and " 5 " corresponding to " complete satisfaction "

  10. health care personnel satisfaction assessment [ Time Frame: 5 months ]
    We will use the Likert scale 3 hours after the session (" 0 " corresponding to " no satisfaction " and " 5 " corresponding to " complete satisfaction "



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04917120


Contacts
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Contact: Maylis LESGOURGUES, Nursery nurse 0144736711 maylis.lesgourgues@aphp.fr
Contact: Jenny YOUN, MD 0144736220 jenny.youn@aphp.fr

Locations
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France
Trousseau Hospital, General pediatric departement Recruiting
Paris, France, 75012
Contact: Maylis LESGOURGUES, Nurse    0144736711    maylis.lesgourgues@aphp.fr   
Contact: Marie-Hélène Odièvre Montanié, MD    0144736220    marie-helene.odievre@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Chair: Sophie DUGUE Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04917120    
Other Study ID Numbers: APHP20201280
IDRCB2020-AO2248-31 ( Other Identifier: ANSM )
First Posted: June 8, 2021    Key Record Dates
Last Update Posted: October 18, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sickle cell disease
Pain
Virtual reality
Vaso occlusive crises
Hypnosis
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn