Examining Bluetooth Haptic Device Use for Pain and Anxiety Reduction in Vascular Access Procedures
Purpose
This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.
Conditions
- Pain
- Anxiety
Eligibility
- Eligible Ages
- Between 4 Years and 99 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BHD synced with mobile game |
At the beginning of the vascular access procedure, the BHD will be applied 5 cm above the needle insertion site and maintained in place throughout the procedure. It delivers a constant low-frequency vibration as well as tactile feedback from the game (GF). |
|
|
Other BHD only |
The patient will wear the BHD 5 cm above the needle insertion site for the duration of the procedure. The BHD will deliver constant low-frequency vibration (CF). |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Stanford University
