NCT05042479Completed
Using of Virtual Reality to Relieve Procedural Pain in Pediatric Oncology.
Source: ClinicalTrials.gov · Last updated 31 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 25 Aug 2021
- Start date
- 30 Jun 2022
- Primary completion date
- 12 Dec 2024
- Lead sponsor
- Nantes University Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT05042479
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 30 Jun 2022 to the primary completion date, 12 Dec 2024
- 1 site 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
- 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
Who the study is looking for
- 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.
Age in the registry: 7 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nantes CHU Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.