Actively Recruiting
Impact of Virtual Reality in Hematology and Oncology for Pain Management During Invasive Procedures in Children, Adolescents and Young Adults Aged 7 to Under 25 Years in a Pilot Study
Led by Poitiers University Hospital · Updated on 2024-12-16
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to test the use of medical hypnosis through virtual reality (VR) during invasive medical procedures in children and young adults with cancer. It focuses on patients aged 7 to under 25 years who require lumbar puncture and chemotherapy via an implantable venous access. The study compares VR to usual care methods like nitrous oxide, anxiolytics, opioid analgesics, and psychotropic drugs to see if VR provides similar benefits in managing pain and anxiety. Participants will be randomly assigned to either the VR group or the usual care group. Both groups will receive a local anesthetic cream and have their pain and anxiety assessed. In the VR group, patients will wear a VR headset starting before and during the procedure. In the usual care group, patients receive standard treatments including nitrous oxide and medications. Physiological signs such as respiratory rate, oxygen saturation, and pulse will be monitored during the procedures. Participants will be followed for one month, with assessments at each lumbar puncture and implantable chamber connection. Pain levels, anxiety, medication use, and vital signs will be recorded to compare the two groups. The study aims to understand if VR can effectively manage procedural pain and anxiety. Safety, tolerance, and detailed pain measurements will be evaluated during this period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 7 to strictly under 25 years
- Under follow-up for hematological or oncological disease
- Scheduled for lumbar puncture or connection to an implantable venous chamber
- Able to understand French
- Consent given by parents or guardians with parental authority
- Child informed and has given their assent
You will not qualify if you...
- Children with cognitive impairment
- Children in absolute emergency situations
- Contraindication to virtual reality headset use (including psychiatric disorders, vestibular or proprioceptive issues, uncontrolled epilepsy, impaired vision, hearing aids, claustrophobia, recent lesions of eyes, face, or scalp)
- Previous participation in this clinical trial
- Refusal to participate
- Lack of social security coverage or coverage through a third party
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day per invasive procedure
Participants receive a local anesthetic cream and undergo pain and anxiety assessment. They experience lumbar puncture or connection to an implantable venous chamber while wearing a virtual reality headset or receiving usual care. Physiological constants are recorded during each procedure.
Visits occur on days of invasive procedures
Duration - Up to 1 month
Participants are monitored for pain, anxiety, physiological responses, analgesic use, and tolerance for up to one month after each invasive procedure.
Follow-up visits after each invasive procedure for assessments
Trial Site Locations
Total: 1 location
1
CHU poitiers
Poitiers, France
Actively Recruiting
Research Team
A
Amandine AF FERNANDES
K
Karine KG ESTEVE-GARNIER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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