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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06271642
Enrollment
200
Registered
2024-02-22
Start date
2024-06-06
Completion date
2024-07-12
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain

Keywords

vibrating device

Brief summary

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

Interventions

BEHAVIORALBluetooth 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.

BEHAVIORALBluetooth 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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mechanical Pain Thresholdimmediately after interventionMechanical 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

MeasureTime frameDescription
Mechanical pain sensitivityimmediately after interventionMechanical 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 scoresimmediately after interventionAnxiety level measured by a numerical rating scale (NRS) from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026