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
| NCT ID | NCT05275881 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Poitiers University Hospital |
| Condition | Virtual Reality |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-10-13 |
| Primary Completion | 2026-11-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-10-13 with a primary completion date of 2026-11-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Amandine AF FERNANDES
PRINCIPAL INVESTIGATOR
Poitiers University Hospital
Frequently Asked Questions
Who can join the NCT05275881 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 24 Years, studying Virtual Reality. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05275881 currently recruiting?
Yes, NCT05275881 is actively recruiting participants. Contact the research team at amandine.fernandes@chu-poitiers.fr for enrollment information.
Where is the NCT05275881 trial being conducted?
This trial is being conducted at Poitiers, France.
Who is sponsoring the NCT05275881 clinical trial?
NCT05275881 is sponsored by Poitiers University Hospital. The principal investigator is Amandine AF FERNANDES at Poitiers University Hospital. The trial plans to enroll 60 participants.