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

NCT05275881 | Recruiting

• 1 other identifier: HOPPIVR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Pediatrics; Cancer; Pain; Procedural Pain

Keywords

Virtual Reality; Pediatrics; Cancerology; Pain; Invasive Acts

Outcome Measures

Primary Outcomes (1)

• 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.

  At the inclusion, the primary endpoint will be to assess pain using the Visual Analogue Scale (VAS) after the first invasive act of lumbar puncture or connection to an implantable chamber. The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The EVA (Analogue Visual Assessment) from 0 to 10, is a scale that can be used from the age of 7. It reliably allows self-assessment of pain. The scale will be explained to the child before the act and it will be presented to him after the invasive act for the assessment: * 0: no pain * Between 1 and 3: mild pain * Between 3 and 5: moderate-intensity pain * Between 5 and 7: severe pain * Greater than 7: very intense pain

  up to one day

Secondary Outcomes (9)

• Comparison, between the control group and the group supported with virtual reality: Pain from the VAS after the 1st connection to the implantable chamber

  up to one month

• Comparison, between the control group and the group supported with virtual reality: Child's anxiety using the Frankl scale

  up to one month

• 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)

  up to one month

• Comparison, between the control group and the group supported with virtual reality: Heart rate

  up to one month

• Comparison, between the control group and the group supported with virtual reality:oxygen saturation

  up to one month

Study Arms (2)

Virtual Reality headset Group

EXPERIMENTAL

30 patients will be included in the virtual reality arm

Device: Virtual Reality

Control group with usual practices

ACTIVE COMPARATOR

30 patients will be included the usual practices

Drug: Usual Practices

Interventions

Virtual Reality 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.

Virtual Reality headset Group

Usual Practices 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

Control group with usual practices

Eligibility Criteria

• Age: 7 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU poitiers

Poitiers, France

RECRUITING

MeSH Terms

Conditions

Neoplasms; Pain; Pain, Procedural

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amandine AF FERNANDES

  Poitiers University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandine AF FERNANDES

CONTACT

+33549444578; amandine.fernandes@chu-poitiers.fr

Karine KG ESTEVE-GARNIER

CONTACT

+33549443567; karine.garnier@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 11, 2022
• Study Start: October 13, 2022
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): December 13, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)