Clinical trial

Impact of Virtual Reality in Pediatric Hematology and Oncology for the Management of Pain During Invasive Procedures in Children 7 to Under 18 Years in a Pilot Study

Name

HOPPIVR

Description

This pilot study will be testing the feasibility of medical hypnosis through virtual reality during invasive médical procédures in children with cancer. Patients age from 7 to under 18 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.

Trial arms

Trial start

2022-10-13

Estimated PCD

2024-11-13

Trial end

2024-12-13

Status

Recruiting

Treatment

Virtual 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.

Arms:

Virtual Reality headset Group

Usual 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

Arms:

Control group with usual practices

Size

Primary endpoint

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.

up to one day

Eligibility criteria

Inclusion Criteria: * Patients aged 7 to strictly under 18 * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-02-12

1 organization

1 product

5 indications

Organization

Poitiers University Hospital

Product

Indication

Indication

Indication

Indication

Indication