Clinical trial · Interventional
Using of Virtual Reality to Relieve Procedural Pain in Pediatric Oncology.
- 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)
Medical procedures can be a very frightening experience for children. It is known that children who received painful medical procedures can develop a higher sensitivity of pain during their following experiences. During their treatments for malignant diseases, children are exposed to a lot of painful procedures (eg. needle insertion, lumbar punction, myelogram, etc…) Therefore, medical societies propose the use of interventions like distraction techniques for pain management in complement of pharmacological treatment. In addition, the repetitions of painful procedures and ineffective prevention of pain can create care phobia. Within this context, immersive and participative virtual reality (VR) could be an innovative distraction technique for pain management among children undergoing medical procedures. Attention Pain Theory can explain how virtual reality can reduce the perception of pain. Attention is required to feel pain. When the patient is focused on another subject like an immersive virtual environment, his brain is less available to treat information like painful stimulus from care procedures. The investigators hypothesis is that VR can reduce procedural-related pain and can decrease fear during the following procedures. Results of previous studies are varied : some showed a non-significant reduction of patient's procedural pain despite the use of VR, whereas others concluded to a decrease of pain. The question of the benefit of VR for the patients who are exposed to repeated painful procedures remains still unclear, especially with patients who are likely to feel chronic pain or many pain-related exposures. The aim of this study is to evaluate the non-inferiority of virtual reality as a distraction technique for pain management in children and adolescents with onco-hematological diseases, undergoing painful procedures, compared to standard of care.
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 |
|---|---|---|---|
| Child, Only | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hematologic Non Malignancy | — | UNRESOLVED | — |
| Solid Tumor, Childhood | Childhood Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Choice between usual distraction or virtual reality | Other | — | UNRESOLVED |
| Usual distraction and pain prevention techniques. | Other | — | UNRESOLVED |
| Virtual reality | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Standard treatment then virtual reality then choice between the two
- description
- Efficiency of VR will be evaluated for each patient across 3 potentially painful care-procedures : For the first treatment, the child will benefit usual distraction and pain prevention techniques. For the 2nd, the child will use a VR headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age and parental agreement. For the 3rd treatment, the child will choose his/her favorite technique.
- interventionNames
- Other: Usual distraction and pain prevention techniques.
- Other: Virtual reality
- Other: Choice between usual distraction or virtual reality
Primary outcomes (3)
- measure
- Pain level measured by VAS (self-evaluation) during the first care using standard treatment.
- timeFrame
- Immediately after the first care.
- description
- Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Quantitative component: * Child aged 7 to 18 years * Child followed in pediatric onco-hematology in the context of hematological malignancy or non malignant hematology or solid tumor management. * Child who has already experienced a potentially painful care procedure before entry the study * Child who will have the same potentially painful care procedure (Hüber needle placement or lumbar puncture) on three occasions during the course of their care. * Child with consent. * Child whose parental authority holders have given their consent to participate to the study. Qualitative component: * Professional who used both care-induced pain prevention techniques and agreed to be interviewed. * A parent or guardian. Exclusion Criteria: * Child who refuse to use this distraction technique (VR). * Child who refuse to not use MEOPA during VR. * Child who hasn't experienced the potentially painful care procedure that will be done during the study at least once before inclusion * Child who does not speak French and whose parents do not speak French
References
Publications (0)
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