Impact of Vibrating Device Distraction on Mechanical Pain Thresholds Induced by Needle Sham

Stanford University

Status: Completed

Conditions: Anxiety; Pain

Treatments: Behavioral: Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only; Behavioral: Bluetooth Haptic Device (Control Frequency) + Needle Sham only

Study type: Interventional

Funder types: Other

Identifiers

NCT06271642

73822

Details and patient eligibility

About

This is a prospective, crossover study of healthy participants evaluating the mechanical pain threshold for weighted pinprick stimuli.

Enrollment: 200 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Greater than 18 years of age
• English speaking
• Hearing intact

Exclusion criteria

• History of chronic pain or acute pain syndromes
• History of neurological, internal or psychiatric conditions
• Has active infections on arms and hand
• Has hearing loss
• Is pregnant
• Is currently taking beta blockers, chronotropic heart medications, or opioids or other prescription pain medications

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Bluetooth Haptic Device (Experimental Frequency) + Needle Sham

Experimental group

Description:

Bluetooth Haptic Device with experimental vibrating frequency will be placed on the arm of the participant, with weighted pinpricks with fixed stimulus intensities will be applied.

Treatment:

Behavioral: Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only

Bluetooth Haptic Device (Control Frequency) + Needle Sham

Sham Comparator group

Description:

Bluetooth Haptic Device with control vibrating frequency will be placed on the arm of the participant, with weighted pinpricks with fixed stimulus intensities will be applied.

Treatment:

Behavioral: Bluetooth Haptic Device (Control Frequency) + Needle Sham only