Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Ac… (NCT06697275) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia
France120 participantsStarted 2024-11-15
Plain-language summary
Main objective:
Evaluate the effectiveness of the repeated use of interactive or hypnotic virtual reality compared to standard treatment, on pain, during each needle placement on PAC for 3 months on children or adolescents (6 to 16 years old) with acute leukemia
Hypothesis:
Repeated use over 3 months of hypnotic or interactive virtual reality provides more benefits in terms of :
* pain management
* anxiety of the child and his parents
* satisfaction of the child's care, of his parents and of the caregivers compared to the standard method when inserting a needle into an implantable port in the pediatric oncology department or day hospital.
Who can participate
Age range
6 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children from 6 to 16 years old suffering from leukemia requiring needle insertion into an implantable port and having a life expectancy greater than or equal to 3 months
* Subjects and their parents who have been informed of the study and having expressed their informed consent
* Children without contraindications to the use of MEOPA® :
* Patient requiring 100% oxygen ventilation
* Intracranial hypertension
* Any alteration in the state of consciousness preventing the patient\'s cooperation
* Children without contraindication to the use of the virtual reality mask:
* Epilepsy
* Psychiatric illness
* Children and parents able to use the self-assessment scales proposed in the study
* Enrolment in the Social Security system
Exclusion Criteria:
Children from 6 to 16:
* Having a modification of pain\'s integration (spina bifida for example)
* Requiring contact isolation (conjunctivitis, contagious skin condition, etc.)
* With a history of seizures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.