Examining Bluetooth Haptic Device Use for Pain and Anxiety Reduction in Vascular Access Procedures
NCT ID: NCT06234228
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1100 participants
INTERVENTIONAL
2024-07-25
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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).
BHD synced with mobile game
The BHD delivers a constant low-frequency vibration as well as tactile feedback from the game (GF).
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).
Bluetooth Haptic Device (BHD)
The BHD will deliver constant low-frequency vibration (CF).
Standard of Care
The participant will not receive the BHD device. Participant will receive standard of care treatment.
No interventions assigned to this group
Interventions
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Bluetooth Haptic Device (BHD)
The BHD will deliver constant low-frequency vibration (CF).
BHD synced with mobile game
The BHD delivers a constant low-frequency vibration as well as tactile feedback from the game (GF).
Eligibility Criteria
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Inclusion Criteria
* Will undergo a vascular access procedure
* English speaking participant and parent or LAR
Exclusion Criteria
* 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
4 Years
99 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Thomas Caruso
Clinical Professor
Principal Investigators
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Thomas Caruso, MD,PhD
Role: STUDY_DIRECTOR
Stanford University
Locations
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Lucile Packard Childrens Hospital Stanford
Palo Alto, California, United States
Countries
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Central Contacts
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Facility Contacts
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Thomas Caruso, MD, PhD
Role: primary
Other Identifiers
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73750
Identifier Type: -
Identifier Source: org_study_id