Sickle Cell Disease Clinical Trial
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
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
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02227472 -
Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease
|
||
Recruiting |
NCT06301893 -
Uganda Sickle Surveillance Study (US-3)
|
||
Recruiting |
NCT04398628 -
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
|
||
Completed |
NCT02522104 -
Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)
|
Phase 4 | |
Recruiting |
NCT04688411 -
An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease
|
N/A | |
Terminated |
NCT03615924 -
Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease
|
Phase 3 | |
Not yet recruiting |
NCT06300723 -
Clinical Study of BRL-101 in Severe SCD
|
N/A | |
Recruiting |
NCT03937817 -
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|
||
Completed |
NCT04917783 -
Health Literacy - Neurocognitive Screening in Pediatric SCD
|
N/A | |
Completed |
NCT04134299 -
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease
|
N/A | |
Completed |
NCT02580565 -
Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide and Analgesics in the Sickle-cell Disease
|
||
Recruiting |
NCT04754711 -
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
|
N/A | |
Completed |
NCT04388241 -
Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD
|
N/A | |
Recruiting |
NCT05431088 -
A Phase 2/3 Study in Adult and Pediatric Participants With SCD
|
Phase 2/Phase 3 | |
Completed |
NCT01158794 -
Genes Influencing Iron Overload State
|
||
Recruiting |
NCT03027258 -
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
|
N/A | |
Withdrawn |
NCT02960503 -
Macrolide Therapy to Improve Forced Expiratory Volume in 1 Second in Adults With Sickle Cell Disease
|
Phase 1/Phase 2 | |
Completed |
NCT02567682 -
Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects
|
Phase 1 | |
Withdrawn |
NCT02630394 -
A Pilot Study of Azithromycin Prophylaxis for Acute Chest Syndrome in Sickle Cell Disease
|
Phase 1 | |
Completed |
NCT02620488 -
A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease
|
N/A |