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

NCT06234228 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Bluetooth Haptic Device (BHD)

The BHD will deliver constant low-frequency vibration (CF).

BEHAVIORAL

BHD synced with mobile game

The BHD delivers a constant low-frequency vibration as well as tactile feedback from the game (GF).

Sponsors & Collaborators

Principal Investigators

  • Thomas Caruso, MD,PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-25
Primary Completion
2025-11-04
Completion
2026-11-04

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06234228 on ClinicalTrials.gov