NCT06697275Recruiting
Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia
Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia: Randomized Multicenter Trial
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 18 Nov 2024
- Start date
- 15 Nov 2024
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Diseases
- Childhood cancers
- NCT number
- NCT06697275
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 15 Nov 2024 to the primary completion date, 1 Oct 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Requiring contact isolation (conjunctivitis, contagious skin condition, etc.)
- With a history of seizures
Other
- Children from 6 to 16:
- Having a modification of pain\'s integration (spina bifida for example)
Who the study is looking for
- 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
Age in the registry: 6 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU de Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.