Pain Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 13, 2024 |
Est. primary completion date | November 13, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU poitiers | Poitiers |
Lead Sponsor | Collaborator |
---|---|
Poitiers University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
up to one month | |
Secondary | 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 18 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. |
up to one month | |
Secondary | 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 | up to one month | |
Secondary | 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) | up to one month | |
Secondary | 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) | up to one month | |
Secondary | 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) | up to one month | |
Secondary | 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 | up to one month | |
Secondary | 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 |
up to one month | |
Secondary | 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 |
up to one month |
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