Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children with Leukemia
Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Nov 18, 2024
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how well virtual reality (VR) can help reduce pain and anxiety in children and teenagers aged 6 to 16 who have leukemia and need a needle inserted into a special device called an implantable port. The study will compare two types of VR – interactive and hypnotic – with the traditional methods used during these procedures. Researchers hope that using VR regularly over three months will make the experience less painful and stressful for both the child and their parents, while also improving their overall satisfaction with the care they receive.
To participate in this trial, children must be diagnosed with leukemia and need the needle insertion, with a life expectancy of at least three months. They should not have certain medical conditions that could interfere with using VR or the standard treatments. If eligible, participants can expect to use VR during their needle placements, and both the child and their parents will be asked for feedback on their experience. This study aims to find better ways to support young patients during these challenging procedures.
Gender
ALL
Eligibility criteria
- 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
About University Hospital, Clermont Ferrand
The University Hospital of Clermont-Ferrand is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. Renowned for its multidisciplinary approach, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes collaboration among healthcare professionals, researchers, and academic partners. With a strong commitment to improving patient outcomes, the institution actively engages in a wide array of clinical studies, ranging from early-phase trials to large-scale interventions, aimed at addressing critical health challenges and enhancing treatment modalities. Its state-of-the-art facilities and expertise make it a pivotal contributor to clinical research in the region and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Toulouse, , France
Bordeaux, , France
Clermont Ferrand, , France
Marseille, , France
Patients applied
Trial Officials
Alexandra USCLADE
Principal Investigator
University Hospital, Clermont-Ferrand
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported