NCT06271642

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Pain
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only	Participants will have the Bluetooth Haptic Device with experimental Frequency placed on their arm and randomized to a series of 4 different vibration patterns/frequencies. Mechanical pain threshold (MPT) will be measure using custom-made weighted pinprick stimuli as a set of five pinprick mechanical stimulators with fixed stimulus intensities (flat contact area of 0.2mm diameter) with forces of 32, 64, 128, 256, and 512mN. The stimulators will be applied at a rate of 2s on, 2s off in a randomized order on participants' forearms until the first sensation of pain is reached and will then be done in descending order until the sensation of pain disappears. This procedure will be repeated five times of ascending and descending stimuli served as pinprick pain threshold on 1 arm at 4 different frequencies/patterns in the BHD.
BEHAVIORAL	Bluetooth Haptic Device (Control Frequency) + Needle Sham only	Participants will have the Bluetooth Haptic Device with control frequency placed on their arm. They will be randomized to a series of 4 different vibration patterns/frequencies. Mechanical pain threshold (MPT) will be measure using custom-made weighted pinprick stimuli as a set of five pinprick mechanical stimulators with fixed stimulus intensities (flat contact area of 0.2mm diameter) with forces of 32, 64, 128, 256, and 512mN. The stimulators will be applied at a rate of 2s on, 2s off in a randomized order on participants' forearms until the first sensation of pain is reached and will then be done in descending order until the sensation of pain disappears. This procedure will be repeated five times of ascending and descending stimuli served as pinprick pain threshold on 1 arm at 4 different frequencies/patterns in the BHD.

Timeline

• Start date: 2024-06-06
• Primary completion: 2024-07-12
• Completion: 2024-07-12
• First posted: 2024-02-22
• Last updated: 2025-09-11

Locations

1 site across 1 country: United States