An interventional study of Virtual Reality and Usual Practices in Virtual Reality, Pediatrics and Cancer, sponsored by Poitiers University Hospital. Recruiting at 1 site in France. Open to participants aged 7 Years to 24 Years. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Supportive care
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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Poitiers University Hospital is the lead sponsor of 314 studies on the registry; 62 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
30 patients will be included in the virtual reality arm
Device: Virtual Reality
30 patients will be included the usual practices
Drug: 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 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.
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
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
Time frame: up to one day
Comparison, between the control group and the group supported with virtual reality: Pain from the VAS after the 1st connection to the implantable chamber
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
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality: Child's anxiety using the Frankl scale
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.
Time frame: 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)
The type of associated analgesics, the dosage will be collected through the patient's medical record
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality: Heart rate
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)
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality:oxygen saturation
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)
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality: Respiratory rate
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)
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality: Tolerance
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
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality: Pain after each act from the VAS
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
Time frame: up to one month
Comparison, between the control group and the group supported with virtual reality: Pain from the VAS after the 1st connection to an implantable chamber
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
Time frame: up to one month
Plan to share: No
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Started Oct 2022 (actual). Primary completion is estimated for Nov 2026, 49 months after the start.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 49 months is above that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
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