Clinical trial NCT05275881: Impact of Virtual Reality in Hematology and Oncology During Invasive Procedures in Children, Adolescents and Young Adults, from 7 to Less Than 25 Years Old
Official title: Impact of Virtual Reality in Hematology and Oncology for the Management of Pain During Invasive Procedures in Children, Adolescents and Young Adults, 7 to Under 25 Years in a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virtual Reality
Pediatrics
Cancer
Pain
Procedural Pain
Keywords: Virtual Reality
Pediatrics
Cancerology
Pain
Invasive Acts
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an exploratory interventional, comparative, single-center, randomized research into 2 parallel groups. The study will compare the use of virtual reality versus usual practices for two iterative and painful acts: lumbar puncture and connection to an implantable chamber.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot study will be testing the feasibility of medical hypnosis through virtual reality during invasive médical procédures in children and young adults with cancer. Patients age from 7 to under 25 years whose treatement protocols required a lumbure puncture and a chemotherapy by implantable venous access will be randomly assigned to virtual reality or treatement as usual (nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine). We expect the same benefit by using VR as usual intervention.

Detailed description: Nationally, around 2,150 new cases of cancer are diagnosed per year in children aged 0 to 18. The main locations are leukemia, central system tumors and lymphomas. The onco-pediatrics unit of the Poitiers University Hospital is recruiting around 70 patients per year from 0 to under 18 years old. 1482 invasive procedures have been done in 2019. The diagnostic and therapeutic methods for these children remain aggressive and involve patients in chronic care. They repeatedly undergo painful and anxiety-inducing care. In pediatrics, nitrous oxide is chosen as the first-line choice in these various procedures, but its effectiveness is not always conclusive, due to habituation, and can induce side effects. For some children, it becomes difficult to obtain their consent to care, despite the range of different analgesics offered, and forces prescribers to increase the drugs. Virtual reality (VR) has already been shown to be effective on pain and anxiety in children and adolescents. This devices uses distraction and hypnosis techniques by establishing a state of hypnosedation and mediation through the work of breathing and sophrology. With this study, we expect the same benefit by using VR as usual pratices.

After explaining the treatment protocol, the potentially eligible patient will be informed by the investigator of the possibility of participating in this clinical trial. After checking the eligibility criteria and including the patient, the investigator can randomize the patient in the control group or the experimental group. As part of this study, patients will be followed for 1 month and for each act of lumbar puncture and connection to an implantable chamber.

Eligibility criteria: Inclusion Criteria:

* Patients aged 7 to strictly under 25
* Follow-ups for hematological or oncological pathology
* With a lumbar puncture or to connection to an implantable chamber
* Patient understanding French
* Consent of parents or guardians with parental authority.
* Child informed and having given his assent

Exclusion Criteria:

* Children with cognitive impairment
* Children in absolute emergency situations
* Children with a contraindication to a virtual reality headset (psychiatric pathology, vestibular and proprioceptive disorders, unbalanced epilepsy, impaired vision, hearing aids, claustrophobia, recent lesions of the eyes, face or scalp)
* Children who have already participated in the clinical investigation
* Refusal to participate in the study
* Patients not benefiting from a social security system or not benefiting from it by the intermediary of a third person

Primary outcomes:
measure: To assess the effectiveness of virtual reality compared to usual analgesic practices in pain management during the first lumbar puncture or connection to an implantable chamber of the study.
timeFrame: up to one day
Secondary outcomes:
measure: Comparison, between the control group and the group supported with virtual reality: Pain from the VAS after the 1st connection to the implantable chamber
timeFrame: up to one month
measure: Comparison, between the control group and the group supported with virtual reality: Child's anxiety using the Frankl scale
timeFrame: up to one month
measure: Comparison, between the control group and the group supported with virtual reality:The type and amount of analgesics consumed during the invasive act (lumbar puncture and / or connection to an implantable chamber)
timeFrame: up to one month
measure: Comparison, between the control group and the group supported with virtual reality: Heart rate
timeFrame: up to one month
measure: Comparison, between the control group and the group supported with virtual reality:oxygen saturation
timeFrame: up to one month
measure: Comparison, between the control group and the group supported with virtual reality: Respiratory rate
timeFrame: up to one month
measure: Comparison, between the control group and the group supported with virtual reality: Tolerance
timeFrame: up to one month
measure: Comparison, between the control group and the group supported with virtual reality: Pain after each act from the VAS
timeFrame: up to one month
measure: Comparison, between the control group and the group supported with virtual reality: Pain from the VAS after the 1st connection to an implantable chamber
timeFrame: up to one month
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU poitiers
Study officials:
affiliation: Poitiers University Hospital
name: Amandine AF FERNANDES
role: PRINCIPAL_INVESTIGATOR
References: