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NCT Number: 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

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.

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Key information

Conditions

Virtual Reality Cancer Neoplasms Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Pediatrics Procedural Pain Signs and Symptoms

Age range

7 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU poitiers

Poitiers, France

Location status: Recruiting

Location contact

Amandine FERNANDES

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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.

    Time frame: up to one day

    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

Secondary outcomes

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

    Time frame: up to one month

    Pain from the VAS after the 1st connection to the implantable chamber:

    The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The VAS (Visual Analogue 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

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

    Time frame: up to one month

    The Frankl scale, is a scale of hetero-evaluation of anxiety. It will be performed by the caregiver before the invasive procedure (lumbar puncture and connection to an implantable chamber). It is suitable for children from 7 to under 25 years old and is easy to score:

    • 0: Definitely negative behavior; refuses treatment, shouts forcefully, opposes/cares,
    • 1: Negative behavior: unwilling to accept care; unwilling to accept care. Some signs of opposition exist but not necessarily declared (sullen air, scowling),
    • 2: Positive behaviour; accepts treatment with reservation. He is cautious but follows the instructions of the practitioner/caregiver
    • 3: Definitely positive behavior; good relations/practitioner/caregiver, interested in treatment. He laughs often and seems to enjoy the visit/care.

  3. 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)

    Time frame: up to one month

    The type of associated analgesics, the dosage will be collected through the patient's medical record

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

    Time frame: up to one month

    Heart rate (min <40 B/min - max >200 B/min), from a scope connected to the patient before and throughout the duration of the invasive act (lumbar puncture and / or connection to an implantable chamber)

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

    Time frame: up to one month

    oxygen saturation (min <90% - max >100%) from a scope connected to the patient before and throughout the duration of the invasive act (lumbar puncture and / or connection to an implantable chamber)

  6. Comparison, between the control group and the group supported with virtual reality: Respiratory rate

    Time frame: up to one month

    Respiratory rate (min <10 - max > 50) from a scope connected to the patient before and throughout the duration of the invasive act (lumbar puncture and / or connection to an implantable chamber)

  7. Comparison, between the control group and the group supported with virtual reality: Tolerance

    Time frame: up to one month

    Tolerance, in number of episodes of confusion, agitation, dizziness, nausea, vomiting, headache, hallucinations and temporary amnesia during the performance of the invasive act and within 2 hours of post-act monitoring for a lumbar puncture and 30 minutes for a connection to an implantable chamber

  8. Comparison, between the control group and the group supported with virtual reality: Pain after each act from the VAS

    Time frame: up to one month

    A patient may have several consecutive invasive acts. The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The VAS (Visual Analogue Assessment) from 0 to 10, is a scale that can be used from the age of 7:

    • 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

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

    Time frame: up to one month

    Pain from the VAS after the 1st connection to an implantable chamber the :

    The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The VAS (Visual Analogue 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

Study contacts

Contact information is provided by the study sponsor or research team.

Amandine AF FERNANDES

CONTACT

[email protected]

+33549444578

Karine KG ESTEVE-GARNIER

CONTACT

[email protected]

+33549443567

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2022
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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