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

Stanford University

Status: Active, not recruiting

Conditions: Anxiety; Pain

Treatments: Behavioral: Bluetooth Haptic Device (BHD); Behavioral: BHD synced with mobile game

Study type: Interventional

Funder types: Other

Identifiers

NCT06234228

73750 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 1,100 estimated patients

Sex: All

Ages: 4 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,100 participants in 3 patient groups

BHD synced with mobile game

Experimental group

Description:

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).

Treatment:

Behavioral: BHD synced with mobile game

BHD only

Other group

Description:

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).

Treatment:

Behavioral: Bluetooth Haptic Device (BHD)

Standard of Care

No Intervention group

Description:

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