Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT04917120
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2021-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DREPAReV
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IDRCB2020-AO2248-31 | OTHER | ANSM | View |