Examining Bluetooth Haptic Device Use for Pain and Anxiety Reduction in Vascular Access Procedures
Overview
- Phase
- N/A
- Intervention
- BHD synced with mobile game
- Conditions
- Pain
- Sponsor
- Stanford University
- Enrollment
- 1100
- Locations
- 1
- Primary Endpoint
- External observation for pain and anxiety using OBSD-r scale
- Status
- Active, Not Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.
Investigators
Thomas Caruso
Clinical Professor
Stanford University
Eligibility 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
Arms & Interventions
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).
Intervention: BHD synced with mobile game
BHD only
The participant 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).
Intervention: Bluetooth Haptic Device (BHD)
Standard of Care
The participant will not receive the BHD device. Participant will receive standard of care treatment.
Outcomes
Primary Outcomes
External observation for pain and anxiety using OBSD-r scale
Time Frame: during vascular access procedure
OBSD-r contains 8-item scale assessing participant's affective state; Information Seeking, Crying, Screaming, Restraint, Verbal Resistance, Emotional Support, Verbal Pain and Flail.
Secondary Outcomes
- Faces Pain Scale-Revised for patients aged 4-11(during vascular access procedure)
- Numerical Rating Pain Scale (NRPS) for patients aged 12-17(during vascular access procedure)
- modified induction compliance checklist (mICC)(during vascular access procedure)
- External observation for pain and anxiety using HRAD scale(during vascular access procedure)
- Children's Anxiety Meter-State (CAM-S) assessment(immediately before, immediately after vascular access procedure)
- Self formulated procedural satisfaction survey (Patient and Parent)(immediately after vascular access procedure)
- Self formulated procedural satisfaction survey (Healthcare provider)(immediately after vascular access procedure)