PainNCT01531400
Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music
A study testing self-selected music in people with Pain and Anxiety, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators hypothesized that self-selected music played during electrodiagnosis is effective in relieving the discomfort caused by the procedures. Read more about this study
- Who is it for?
- Ages 15 years and older
- What is being tested?
- self-selected music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2002to Nov 2005
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Investigators recruited volunteer patient participants from patients referred to the electrodiagnosis laboratory of Department of Physical Medicine and Rehabilitation in a medical center using convenient sampling.
- The inclusion criterion is:
- adult patient with working diagnosis of possible neurological disorder and
- is referred for both nerve conduction study and needle electromyography
Who cannot join
- The exclusion criteria are:
- conscious disturbances,
- cognitive impairment, or
- language dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesized that self-selected music played during electrodiagnosis is effective in relieving the discomfort caused by the procedures.
- Being tested
- self-selected music
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-selected musicOther
Also called self-selected background music
Investigators played self-selected background music in the music group
| Study group | Role | What they receive |
|---|---|---|
| music | Experimental | Investigators played self-selected background music in the music group Receives: Other: self-selected music |
| no music (control) | No intervention | Investigators played no music in the music group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (Visual Analogue Scale)
Measured: baseline and after needle electromyography, to measure the "change" of pain
Secondary outcomes (1)
Anxiety, assessed by Linear Analogue Anxiety Scale (LAAS)
Measured: baseline and after electromyography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startDec 2002
- Primary completionNov 2005
- Study completionNov 2005
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.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Cheng Pei, Chang Gung Memorial Hospital
- Investigators
- Yu-Cheng Pei, MD PhD, Principal investigator, Attending Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531400
- Sponsor's protocol ID
- cgmhpmr001
- Status last verified
- Mar 2012
- First submitted
- 29 Jan 2012
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music
- ClinicalTrials.gov ID
- NCT01531400
- Acronym / sponsor ID
- cgmhpmr001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 13 Feb 2012 (estimated)
- 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 investigators hypothesized that self-selected music played during electrodiagnosis is effective in relieving the discomfort caused by the procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music | Experimental | Other: self-selected musicInvestigators played self-selected background music in the music group |
| no music (control) | No intervention | –Investigators played no music in the music group |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Investigators recruited volunteer patient participants from patients referred to the electrodiagnosis laboratory of Department of Physical Medicine and Rehabilitation in a medical center using convenient sampling.
- adult patient with working diagnosis of possible neurological disorder and
- is referred for both nerve conduction study and needle electromyography
Key exclusion criteria (4 listed)
- conscious disturbances,
- cognitive impairment, or
- language dysfunction.
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 |
|---|---|---|
| self-selected musicAlso: self-selected background musicInvestigators played self-selected background music in the music group | Other | music |
Primary outcome
Pain (Visual Analogue Scale)
Time frame: baseline and after needle electromyography, to measure the "change" of pain
1 secondary outcome
Anxiety, assessed by Linear Analogue Anxiety Scale (LAAS)
Time frame: baseline and after electromyography
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 20 Mar 2012.
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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.
Yu-Cheng Pei, MD PhD principal investigator
Attending Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-selected music in people with Pain and Anxiety, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 4 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 20 Mar 2012. 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 Taiwan. 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?
Pain (Visual Analogue Scale) (time frame: baseline and after needle electromyography, to measure the "change" of pain). 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 20 Mar 2012.