AnalgesiaNCT03410563
The Analgesic Effect of Auditory Inputs and Its Relation to Psychological and Neurobiological Mechanisms
An observational study of Analgesia, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study investigates the analgesic effect of different auditory inputs. Employing a within-subject design, the study includes healthy participants that are exposed to thermal stimuli while listening to three different auditory inputs. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Auditory inputs
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jan 2018to 1 May 2018
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy participants
Who may be able to join
- Healthy participants with normal hearing
Who cannot join
- Chronic pain conditions
- Other medical, psychiatric or neurological disorders
- Use of pain-relieving medication 24 hours prior to testing
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Psychology and Behavioural Sciences
Aarhus C, 8000
About this study
The study investigates the analgesic effect of different auditory inputs. Employing a within-subject design, the study includes healthy participants that are exposed to thermal stimuli while listening to three different auditory inputs. By repeating this on separate test days, the involvement of bodily processes is investigated.
- Conditions
- Analgesia
- Being tested
- Auditory inputs
- Keywords
- Pain, Auditory inputs
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory inputsBehavioural
Three different auditory inputs
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Not described Receives: Behavioral: Auditory inputs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scales
Acute pain assessed on visual analogue scales (0-100) examining pain intensity and pain unpleasantness
Measured: An average of 3 weeks (Participants are tested at three different test days across an average of 3 weeks; the primary outcome measure will be assessed after each thermal stimulus at the three test days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start3 Jan 2018
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410563
- Sponsor's protocol ID
- UAarhus_Sigrid
- Status last verified
- Jan 2018
- First submitted
- 18 Jan 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lunde SJ, Vuust P, Garza-Villarreal EA, Kirsch I, Moller A, Vase L. Music-Induced Analgesia in Healthy Participants Is Associated With Expected Pain Levels but Not Opioid or Dopamine-Dependent Mechanisms. Front Pain Res (Lausanne). 2022 Apr 4;3:734999. doi: 10.3389/fpain.2022.734999. eCollection 2022.
PubMed 35445208
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effect of Auditory Inputs and Its Relation to Psychological and Neurobiological Mechanisms
- ClinicalTrials.gov ID
- NCT03410563
- Acronym / sponsor ID
- UAarhus_Sigrid
- Conditions
- Analgesia
- Keywords
- Pain, Auditory inputs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 25 Jan 2018 (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.
The study investigates the analgesic effect of different auditory inputs. Employing a within-subject design, the study includes healthy participants that are exposed to thermal stimuli while listening to three different auditory inputs. By repeating this on separate test days, the involvement of bodily processes is investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Behavioral: Auditory inputs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy participants
Key inclusion criteria (1 listed)
- Healthy participants with normal hearing
Key exclusion criteria (3 listed)
- Chronic pain conditions
- Other medical, psychiatric or neurological disorders
- Use of pain-relieving medication 24 hours prior to testing
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 |
|---|---|---|
| Auditory inputsThree different auditory inputs | Behavioural | Healthy participants |
Primary outcome
Visual analogue scales
Time frame: An average of 3 weeks (Participants are tested at three different test days across an average of 3 weeks; the primary outcome measure will be assessed after each thermal stimulus at the three test days)
Acute pain assessed on visual analogue scales (0-100) examining pain intensity and pain unpleasantness
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 11 Oct 2018.
- Derived from this study: PubMed 35445208Lunde SJ, Vuust P, Garza-Villarreal EA, Kirsch I, Moller A, Vase L. Music-Induced Analgesia in Healthy Participants Is Associated With Expected Pain Levels but Not Opioid or Dopamine-Dependent Mechanisms. Front Pain Res (Lausanne). 2022 Apr 4;3:734999. doi: 10.3389/fpain.2022.734999. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia, run by University of Aarhus at 1 site in Denmark.
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 1 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 11 Oct 2018. 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 Denmark. 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?
Visual analogue scales (time frame: An average of 3 weeks (Participants are tested at three different test days across an average of 3 weeks; the primary outcome measure will be assessed after each thermal stimulus at the three test days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03410563, which also lists 1 linked publication.
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 11 Oct 2018.