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

NCT ID: NCT06271642

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-06
• Study Completion Date: 2024-07-12

Brief Summary

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

Conditions

Pain; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only

Intervention Type: 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 (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.

Group Type: SHAM_COMPARATOR

Bluetooth Haptic Device (Control Frequency) + Needle Sham only

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Thomas Caruso

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lucile Parkard Children's Hospital

Stanford, California, United States

Countries

United States

Other Identifiers

73822

Identifier Type: -

Identifier Source: org_study_id