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

Not Applicable

Not yet recruiting

• Conditions: Anxiety; Pain
• Interventions: Behavioral: BHD synced with mobile game; Behavioral: Bluetooth Haptic Device (BHD)

• Registration Number: NCT06234228
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15
• Study Start: 2024-06-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BHD synced with mobile game	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 only	Bluetooth Haptic Device (BHD)	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).

Primary Outcome Measures

Name	Time	Method
Numerical Rating Pain Scale (NRPS) for patients aged 12-17	during vascular access procedure	NRPS is a 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain.
Faces Pain Scale-Revised (FPS-R) for patients aged 4-11	during vascular access procedure	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.

Secondary Outcome Measures

Name	Time	Method
Self formulated procedural satisfaction survey	after vascular access procedure	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."
External observation for pain and anxiety using HRAD scale	during vascular access procedure	HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation.
External observation for pain and anxiety using OBSD-r scale	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.
modified induction compliance checklist (mICC)	during vascular access procedure	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.

Trial Locations

Locations (1)

Lucile Packard Childrens Hospital Stanford; 🇺🇸 Palo Alto, California, United States