Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Anxiety and Fear | — | UNRESOLVED | — |
| Children and Adolescents | — | UNRESOLVED | — |
| Virtual Reality | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypnotic Virtual reality | Device | — | UNRESOLVED |
| Interactive virtual reality | Device | — | UNRESOLVED |
| Standard method | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Standard method
- description
- In this standard method, before the treatment, the procedure of inserting the needle into the implantable port is explained to the child. The patient is comfortably installed and the treatment start using the standard method which consist on distracting the patient by singing, story telling, talking etc.. Use of local anesthesic cream and +/- anxiolytic gas
- interventionNames
- Other: Standard method
- type
- ACTIVE_COMPARATOR
- label
- Interactive virtual reality
- description
- Before the treatment, the caregiver explains the procedure of inserting the needle into the implantable port. A general explanation is given on the VR device (how the headphones and headsets are placed), presentation of the virtual worlds to choose from, description of the course of the session (virtual travel is guided by a voice). For the interactive virtual reality, the mode of operation will be explained as the actions are validated using the eyes. The patient is then installed comfortably. The caregiver helps the child to put on the headphones and headset correctly. Before starting the care procedure, the caregiver will wait about 5 minutes after the start of the viewing to make sure the child is completely immersed in the virtual reality. The software is turned off about 3 minutes after the end of the care procedure. Use of local anesthesic cream.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
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