Active — Not RecruitingNot Applicable

Examining Bluetooth Haptic Device Use for Pain and Anxiety Reduction in Vascular Access Procedures

United States1,100 participantsStarted 2024-07-25

Plain-language 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.

Who can participate

Age range4 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

External observation for pain and anxiety using OBSD-r scale

Timeframe: during vascular access procedure

Trial details

NCT IDNCT06234228

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-04

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