RecruitingNot ApplicableNCT05275881

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

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


Sponsor

Poitiers University Hospital

Enrollment

60 participants

Start Date

Oct 13, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 7 YearsMax Age: 24 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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

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Interventions

DEVICEVirtual Reality

In each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the the RV group, The session will be started before the gesture and the patient will wear the helmet throughout the act. In case of pain and / or restlessness, the child will receive analgesics.

DRUGUsual Practices

In each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the control group, the child will receive the usual care: nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine


Locations(1)

CHU poitiers

Poitiers, France

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NCT05275881


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