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

NCT06271642 | Completed

• 1 other identifier: 73822
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Anxiety

Keywords

vibrating device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mechanical pain sensitivity

  immediately after intervention

• Anxiety scores

  immediately after intervention

Study Arms (2)

Bluetooth Haptic Device (Experimental Frequency) + Needle Sham

EXPERIMENTAL

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

Bluetooth Haptic Device (Control Frequency) + Needle Sham

SHAM COMPARATOR

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

Interventions

Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only BEHAVIORAL

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.

Bluetooth Haptic Device (Experimental Frequency) + Needle Sham

Bluetooth Haptic Device (Control Frequency) + Needle Sham only BEHAVIORAL

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.

Bluetooth Haptic Device (Control Frequency) + Needle Sham

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Parkard Children's Hospital

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 22, 2024
• Study Start: June 6, 2024
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

US (1)