PainNCT06165757
The Effects of Non Harmonic and White Noise on Human Pain Sensitivity: a Study of Healthy Volunteers
A study testing noise stimulation in people with Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- noise stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2023to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- A history of alcohol or drug abuse
- Pregnant or lactating
- Severe cardiovascular, kidney, or liver diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
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.
- Conditions
- Pain
- Being tested
- noise stimulation
- Keywords
- Noise, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noise stimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| noise on pain | Experimental | Comparison of pain sensitivity before and after hearing noise among 15 subjects in each group. Receives: Behavioral: noise stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: from the study beginning to 30 min after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start10 Oct 2023
- Primary completion20 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- He Huang, MD, Principal investigator, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165757
- Sponsor's protocol ID
- Noise and pain sensitivit
- Status last verified
- Oct 2023
- First submitted
- 9 Nov 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Non Harmonic and White Noise on Human Pain Sensitivity: a Study of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06165757
- Acronym / sponsor ID
- Noise and pain sensitivit
- Conditions
- Pain
- Keywords
- Noise, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| noise on pain | Experimental | Behavioral: noise stimulationComparison of pain sensitivity before and after hearing noise among 15 subjects in each group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- A history of alcohol or drug abuse
- Pregnant or lactating
- Severe cardiovascular, kidney, or liver diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| noise stimulationApply 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. | Behavioural | noise on pain |
Primary outcome
mechanical pain sensitivity
Time frame: from the study beginning to 30 min after the procedure
Each participant was measured using the pressure pain threshold and tolerance (tested by a pressure meter), which lower value present higher pain sensitivity
cold pain sensitivity
Time frame: from the study beginning to 30 min after the procedure
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
electrical pain sensitivity
Time frame: from the study beginning to 30 min after the procedure
Each participant was measured using the cold pain threshold and tolerance (tested by a electrical stimulator), which lower value present higher pain sensitivity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
He Huang, MD principal investigator
The Second Affiliated Hospital, Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noise stimulation in people with Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mechanical pain sensitivity (time frame: from the study beginning to 30 min after the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.