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

NCT06234228 | Active Not Recruiting

• 1 other identifier: 73750
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety

Keywords

Vascular access

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Faces Pain Scale-Revised for patients aged 4-11

  during vascular access procedure

• Numerical Rating Pain Scale (NRPS) for patients aged 12-17

  during vascular access procedure

• modified induction compliance checklist (mICC)

  during vascular access procedure

• External observation for pain and anxiety using HRAD scale

  during vascular access procedure

• Children's Anxiety Meter-State (CAM-S) assessment

  immediately before, immediately after vascular access procedure

Study Arms (3)

BHD synced with mobile game

EXPERIMENTAL

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

BHD only

OTHER

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).

Behavioral: Bluetooth Haptic Device (BHD)

Standard of Care

NO INTERVENTION

The participant will not receive the BHD device. Participant will receive standard of care treatment.

Interventions

Bluetooth Haptic Device (BHD) BEHAVIORAL

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

BHD only

BHD synced with mobile game BEHAVIORAL

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

BHD synced with mobile game

Eligibility Criteria

• Age: 4 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Between age 4-99
• Will undergo a vascular access procedure
• English speaking participant and parent or LAR

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Childrens Hospital Stanford

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Thomas Caruso, MD,PhD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: July 25, 2024
• Primary Completion: November 4, 2025
• Study Completion (Estimated): November 4, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)