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

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

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety
• Intervention / Treatment: Behavioral: Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only; Behavioral: Bluetooth Haptic Device (Control Frequency) + Needle Sham only

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Lucile Parkard Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bluetooth Haptic Device (Experimental Frequency) + Needle Sham; 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.	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.
Sham Comparator: Bluetooth Haptic Device (Control Frequency) + Needle Sham; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical Pain Threshold	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.	immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical pain sensitivity	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.	immediately after intervention
Anxiety scores	Anxiety level measured by a numerical rating scale (NRS) from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels.	immediately after intervention

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Actual): July 12, 2024
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: vibrating device
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: 73822

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No