Clinical trial NCT04917120: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Sickle cell disease
Pain
Virtual reality
Vaso occlusive crises
Hypnosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: pain assessment with score (patient)
timeFrame: hours 3 after a virtual reality
Secondary outcomes:
measure: pain assessment with score (patient)
timeFrame: 10 minutes before HVR
measure: pain assessment with score (patient)
timeFrame: 1 hour after a virtual reality
measure: pain assessment with score (health care personnel)
timeFrame: 10 minutes before HVR
measure: pain assessment with score (health care personnel)
timeFrame: 1 hour after a virtual reality
measure: pain assessment with score (health care personnel)
timeFrame: 3 hour after a virtual reality
measure: anxiety assessment
timeFrame: 10 minutes before HVR
measure: anxiety assessment
timeFrame: 1 hour after HVR
measure: anxiety assessment
timeFrame: 3 hour after HVR
measure: patient satisfaction assessment
timeFrame: 3 hour
measure: health care personnel satisfaction assessment
timeFrame: 5 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Trousseau Hospital, General pediatric departement
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sophie DUGUE
role: STUDY_CHAIR
References: