Using a vibrating device to reduce pain and anxiety in kids during medical procedures
Examining Bluetooth Haptic Device Use for Pain and Anxiety Reduction in Vascular Access Procedures
NA · Stanford University · NCT06234228
This study is testing if a vibrating device can help reduce pain and anxiety in kids aged 4 to 99 during medical procedures.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 4 Years to 99 Years |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT06234228 on ClinicalTrials.gov |
What this trial studies
This pragmatic, randomized study evaluates the effectiveness of a Bluetooth Haptic Device (BHD) in reducing anxiety and distress in pediatric patients undergoing vascular access procedures. Participants will be children aged 4 to 99 who are English-speaking and will have their pain and anxiety levels assessed during the procedure. The BHD may be synced with a mobile game to enhance its effectiveness. The study aims to provide a non-invasive method to improve the experience of young patients during potentially distressing medical interventions.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 99 who are scheduled for a vascular access procedure and can self-report their pain and anxiety.
Not a fit: Patients who are unable to self-report pain or anxiety, or those with significant neurological conditions or major developmental disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and anxiety in pediatric patients during vascular access procedures.
How similar studies have performed: Other studies have shown promise in using technology and devices to alleviate anxiety and pain in medical settings, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between age 4-99 * Will undergo a vascular access procedure * English speaking participant and parent or LAR Exclusion Criteria: * Legal guardian not present to obtain consent * Child is unable to self-report pain or anxiety * Child with a significant neurological condition, or major developmental disability * Child with active infection of the hand or arm * Major surgery within the last 48 hours
Where this trial is running
Palo Alto, California
- Lucile Packard Childrens Hospital Stanford — Palo Alto, California, United States (RECRUITING)
Study contacts
- Study coordinator: Thomas Caruso, MD, PhD
- Email: tjcaruso@stanford.edu
- Phone: 650-723-5728
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.
Conditions: Pain, Anxiety, Vascular access