A groundbreaking clinical trial is set to investigate the impact of the Snoezelen device on anxiety symptoms in pediatric patients undergoing chemotherapy. Scheduled at the Centre Oscar Lambret, this study could bridge an important gap in therapeutic approaches for symptom relief in pediatric oncology.
Led by collaborative sponsorship from Centre Oscar Lambret, PETRARQUE, and Scalab CNRS 9193, the study has not yet commenced recruitment but aims to provide critical insights for clinical and regulatory teams.
What changed?
The Snoezelen device is under evaluation for its potential to alleviate anxiety symptoms in a highly vulnerable group: pediatric patients receiving chemotherapy. The trial will use a combination of self-report questionnaires and structured research interviews to document patient experiences rigorously. This method aligns with standard clinical trial practices, ensuring the study’s findings will hold scientific and regulatory merit once complete.
What is the study focus?
Researchers plan to examine the Snoezelen device’s role in reducing anxiety levels during hospitalization. The device uses sensory-based interventions, which are known to help regulate emotions but lack significant clinical trial validation in oncology settings. This study builds upon preliminary evidence that such interventions could improve patient well-being during chemotherapy.
The primary conditions addressed will include anxiety and distress stemming from pediatric cancer treatment regimens. These interventions will be assessed for both efficacy and safety, ensuring compliance with stringent clinical regulations.
Who is affected?
The trial targets pediatric patients hospitalized for chemotherapy in oncology centers, particularly those experiencing heightened anxiety as a symptom. Clinical and regulatory professionals monitoring developments in pediatric cancer care will find actionable implications in this trial’s findings.
If successful, the Snoezelen device could emerge as a valuable adjunctive tool in managing emotional challenges associated with pediatric oncology care. This could also influence broader device classification discussions and therapeutic exemptions within regulatory frameworks for medical devices.
FAQs
- When is recruitment expected to begin?
Recruitment timelines have not yet been announced.
- What data collection methods will be used?
Patient responses will be collected through self-report questionnaires and research interviews.
- Where is the trial being conducted?
The trial will take place at Centre Oscar Lambret, a prominent pediatric oncology facility.
- What are the conditions under evaluation?
The study will focus on anxiety symptoms in pediatric cancer patients undergoing chemotherapy.
Conclusion
This clinical research highlights innovation in pediatric oncology care, aiming to introduce an evidence-supported sensory intervention for managing anxiety. For medical device professionals and clinical quality teams, close monitoring of this trial’s progress is advisable to assess industrial and therapeutic implications.
Disclaimer
This article provides general information and analysis suited for clinical and regulatory professionals. It should not be considered legal advice or endorsement of the device under investigation.
Link to original announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07202507?term=medical+device