Examining Bluetooth Haptic Device Use for Pain and Anxiety Reduction in Vascular Access Procedures (VA+BHD)

This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Anxiety
• Intervention / Treatment: Behavioral: BHD synced with mobile game; Behavioral: Bluetooth Haptic Device (BHD)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Man Yee Suen, MMedSc; Phone Number: 650-723-5728; Email: msuen@stanfordchildrens.org
• Study Contact Backup: Name: Thomas Caruso, MD, PhD; Phone Number: 650-723-5728; Email: tjcaruso@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between age 7-25
• Will undergo a vascular access procedure
• English speaking participant and parent or LAR

Exclusion Criteria:

• Legal guardian not present to obtain consent
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Behavioral: BHD synced with mobile game; The BHD 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).	Behavioral: Bluetooth Haptic Device (BHD); The BHD will deliver constant low-frequency vibration (CF).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Faces Pain Scale-Revised (FPS-R) for patients aged 4-11	Detailed qualitative review of cognitive interview probes with question-by-question analysis of transcribed cognitive interviews to assess for basic comprehension and appropriate use of the FPS-R.	during vascular access procedure
Numerical Rating Pain Scale (NRPS) for patients aged 12-17	NRPS is a 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain.	during vascular access procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
External observation for pain and anxiety using HRAD scale	HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation.	during vascular access procedure
External observation for pain and anxiety using OBSD-r scale	OBSD-r contains 8-item scale assessing participant's affective state; Information Seeking, Crying, Screaming, Restraint, Verbal Resistance, Emotional Support, Verbal Pain and Flail.	during vascular access procedure
modified induction compliance checklist (mICC)	The mICC score will be recorded by the trained research observers during the vascular access procedure. Perfect compliance (score of 0) was compared to those that lacked cooperation. mICC will be rated at the time of intervention and only requires one RA.	during vascular access procedure
Self formulated procedural satisfaction survey	The survey contains 10 items and utilizes a 5-point Likert agreement scale with a score of 1 meaning "completely disagree" and 5 meaning "completely agree."	after vascular access procedure

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Study Director: Thomas Caruso, MD,PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Vascular access
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 73750 (Stanford IRB, old system)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No