The Effects of Non Harmonic and White Noise on Human Pain Sensitivity: a Study of Healthy Volunteers

Study the effects of 60dB and 80dB white noise, 50-70dB and 70-90dB non harmonic tones on the basic pain threshold of subjects, including the threshold and tolerance of electrical stimulation pain,the threshold and tolerance of cold pain stimulation, and the threshold and tolerance of tenderness stimulation.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Behavioral: noise stimulation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guangyou Duan, MD; Phone Number: (+86)18323376014; Email: duangy@hospital.cqmu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Between the ages of 18 and 35, regardless of gender
• No serious chronic diseases
• There is no self-reported history of chronic opioid drug use or neuropathy

Exclusion Criteria:

• A history of alcohol or drug abuse
• Pregnant or lactating
• Severe cardiovascular, kidney, or liver diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: noise on pain; Comparison of pain sensitivity before and after hearing noise among 15 subjects in each group.	Behavioral: noise stimulation; Apply non harmonic and white noise sound stimuli to the subjects, and then measure the threshold and tolerance values of pressure pain, cold pain, and electrical pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mechanical pain sensitivity	Each participant was measured using the pressure pain threshold and tolerance (tested by a pressure meter), which lower value present higher pain sensitivity	from the study beginning to 30 min after the procedure
cold pain sensitivity	Each participant was measured using the cold pain threshold and tolerance (tested by immersion the hand in 4℃ water), which lower value present higher pain sensitivity	from the study beginning to 30 min after the procedure
electrical pain sensitivity	Each participant was measured using the cold pain threshold and tolerance (tested by a electrical stimulator), which lower value present higher pain sensitivity	from the study beginning to 30 min after the procedure

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Principal Investigator: He Huang, MD, The Second Affiliated Hospital, Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Noise
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: Noise and pain sensitivit

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No