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Tests treatment safety and results for Virtual Reality
Official title Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia
ClinicalTrials.gov ID: NCT06697275
What this study is testing
- What it's testing
- 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.
- Time commitment: about 3 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 16
You may be able to join if
- Children from 6 to 16 years old suffering from leukemia requiring needle insertion into an implantable port and having a life expectancy greater than...
- people 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
You likely can't join if
- 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
See the full eligibility 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
- people 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Clermont-Ferrand, France
- Marseille, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Clermont-Ferrand, France; Marseille, France; Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.