Impact of Bluetooth Haptics Device Distraction on Mechanical Pain Thresholds Induced by PinPrick Stimulators

Not Applicable

Recruiting

• Conditions: Pain; Anxiety
• Interventions: Behavioral: Bluetooth Haptic Device (Control Frequency) + Needle Sham only; Behavioral: Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only

• Registration Number: NCT06271642
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-22
• Status Verified: 2024-06
• Study Start: 2024-06-06
• Last Update Submitted: 2024-06-22
• Last Update Posted: 2024-06-25
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• History of chronic pain or acute pain syndromes
• Currently has nausea
• Has hearing loss
• Is pregnant
• Is currently taking beta blockers, chronotropic heart medications, or opioids or other prescription pain medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bluetooth Haptic Device (Control Frequency) + Needle Sham	Bluetooth Haptic Device (Control Frequency) + Needle Sham only	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.
Bluetooth Haptic Device (Experimental Frequency) + Needle Sham	Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only	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.

Primary Outcome Measures

Name	Time	Method
Mechanical Pain Threshold	immediately after intervention	Mechanical Pain Threshold will be measured using custom-made weighted pinprick stimuli as a set of seven pinprick mechanical stimulators with fixed stimulus intensities (flat contact area of 0.2mm diameter) with forces of 8, 16, 32, 64, 128, 256, and 512mN.

Secondary Outcome Measures

Name	Time	Method
Mechanical pain sensitivity	immediately after intervention	Mechanical pain sensitivity will be taken immediately following each group of levels tests from 0-10; 0=no pain to 10=worst pain ever experienced.
Anxiety scores	immediately after intervention	Anxiety level measured by a numerical rating scale (NRS) from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels.

Trial Locations

Locations (1)

Lucile Parkard Children's Hospital; 🇺🇸 Stanford, California, United States