Using virtual reality to reduce pain and anxiety during needle placements 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
This study tests if using virtual reality can help reduce pain and anxiety for kids with leukemia during needle placements.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 6 Years to 16 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Bordeaux and 3 other locations) |
| Trial ID | NCT06697275 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of using interactive or hypnotic virtual reality to manage pain and anxiety during needle placements for children and adolescents aged 6 to 16 with acute leukemia. Over a period of three months, participants will receive either virtual reality interventions or standard treatment while undergoing needle insertion into an implantable port. The study aims to assess improvements in pain management, anxiety levels, and overall satisfaction for both the children and their caregivers compared to traditional methods. The goal is to provide a non-drug intervention that enhances the care experience for these young patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 16 diagnosed with leukemia who require needle insertion into an implantable port and have a life expectancy of at least three months.
Not a fit: Patients with conditions that contraindicate the use of virtual reality or those with severe neurological or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and anxiety for children undergoing frequent medical procedures.
How similar studies have performed: Previous studies have shown promising results using virtual reality for pain and anxiety management in pediatric populations, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux and 3 other locations
- CHU de Bordeaux — Bordeaux, France (Recruiting)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- Assistance Publique - Hôpitaux de Marseille — Marseille, France (Recruiting)
- CHU de Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Alexandra USCLADE — University Hospital, Clermont-Ferrand
- Study coordinator: Lise LACLAUTRE
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.