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

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-13
• Study Completion Date: 2026-12-13

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.

Conditions

Virtual Reality; Pediatrics; Cancer; Pain; Procedural Pain

Keywords

Virtual Reality; Pediatrics; Cancerology; Pain; Invasive Acts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality headset Group

30 patients will be included in the virtual reality arm

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

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.

Control group with usual practices

30 patients will be included the usual practices

Group Type: ACTIVE_COMPARATOR

Usual Practices

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amandine AF FERNANDES

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Locations

CHU poitiers

Poitiers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Amandine AF FERNANDES

Role: CONTACT

Phone: +33549444578

Email: amandine.fernandes@chu-poitiers.fr

Karine KG ESTEVE-GARNIER

Role: CONTACT

Phone: +33549443567

Email: karine.garnier@chu-poitiers.fr

Facility Contacts

Amandine FERNANDES

Role: primary

Other Identifiers

HOPPIVR

Identifier Type: -

Identifier Source: org_study_id