AnxietyNCT03610503
The Effect of Preferred Music on EMG Anxiety and Pain
A study testing Music in people with Anxiety and Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients often report anxiety and pain related to electromyography (EMG) and nerve conduction studies (NCS) which are tests used to look for diseases of the nerves and muscles. Unfortunately, for those with very high levels of test related stress, the experience may be very frightening and may impede completion of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Pain, Nerve Injury
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2018to 30 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older referred for NCS and EMG at Mount Hope Centre for Long Term Care in London, Ontario will be eligible and offered entry into the study if the following criteria are met: the NCS/EMG are indicated, they have at least a 6th grade reading level in English such that they can complete the STAI, and the patient is willing and able to provide signed informed consent.
Who cannot join
- Use of hearing aids that would preclude or hinder the use of over-ear headphones.
- Profound hearing loss.
- Cognitive Impairment
Trial locations and contacts
1 site in 1 country.
Canada1 site
Mount Hope EMG Lab, St. Joseph's Health Care (SJHC)
London, Ontario, N6A 1Y6
About this study
Official title: The Effect of Preferred Music on Anxiety and Pain in Electrodiagnostic Studies: A Prospective Randomized Trial
Patients often report anxiety and pain related to electromyography (EMG) and nerve conduction studies (NCS) which are tests used to look for diseases of the nerves and muscles. Unfortunately, for those with very high levels of test related stress, the experience may be very frightening and may impede completion of the study and negatively impact on making a timely and accurate diagnosis. Several studies have shown that music can improve anxiety and pain levels in various situations and procedures. Our study will allow participants to play music of their choice during EMG and NCS in order to determine if the pain and anxiety that they experience is reduced.
Read the detailed description
This study will be a prospective randomized trial carried out at Mount Hope Centre for Long Term Care in London, Ontario. All patients referred for electromyography and a nerve conduction study will be considered for inclusion in the study. Those who meet the criteria and verbally consent to the study will sign a consent form and then be randomly assigned to either a music or no-music group using a computer-generated random number series. Prior to starting the test, all participants who enroll in the study will complete form Y-1 and Y-2 of the state-trait anxiety inventory (STAI) which measure state (S) anxiety and trait (T) anxiety respectively. They will also complete an 100 mm visual analogue scale (VAS) for pain and anxiety prior to beginning the studies. During and following the test they will be asked to complete a VAS for pain and anxiety, and the Y-1 of the STAI to measure state anxiety. Aside from having to fill out the STAI and visual analogue scales, patients assigned to the no-music group will undergo the EMG and NCS as per usual. Those in the music group will be given a set of over-ear headphones (sterilized before use) and a tablet device. Participants will be allowed to navigate Spotify, a digital music service to select whatever music they desire. An app that limits volume will be used to ensure that volume cannot be raised above 80 decibels by the patient. Communication with the patient will not be hindered as the EMG technician and physician will be speaking into a microphone that transmits the sound directly to the participant's headphones.
- Conditions
- Anxiety, Pain, Nerve Injury
- Being tested
- Music
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Participants in this arm will listen to music during the EMG testing
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Patients listen to music during EMG test Receives: Other: Music |
| Control (Standard Care) | No intervention | Patients do not listen to music during EMG test (ie. Standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-trait anxiety inventory (STAI)
Anxiety inventory that measures both Trait (T) and State (S) anxiety. Each sub- scale (T and S) is measured from 20-80 and reported individually (not combined) with higher values indicating higher anxiety. The typical cut off for S sub-scale is a score greater than 40 indicating clinically significant symptoms.
Measured: Change in STAI (State sub-scale) from immediately before the EMG procedure, during the EMG procedure and immediately after EMG procedure
Secondary outcomes (1)
Visual analog scale (VAS) for pain and anxiety scale (0-100)
Pain and anxiety scale using a standard VAS (0 = No pain/anxiety, 100 = maximal).
Measured: Change in VAS immediately before the EMG procedure, during the EMG procedure, and immediately after EMG procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Sep 2018
- Primary completion30 Apr 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, intervention-control, trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Macaluso, M.D., Principal investigator, Schulich School of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610503
- Sponsor's protocol ID
- REDA 5189
- Status last verified
- Mar 2019
- First submitted
- 12 Jul 2018
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preferred Music on Anxiety and Pain in Electrodiagnostic Studies: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03610503
- Acronym / sponsor ID
- REDA 5189
- Conditions
- Anxiety, Pain, Nerve Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 1 Aug 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.
Patients often report anxiety and pain related to electromyography (EMG) and nerve conduction studies (NCS) which are tests used to look for diseases of the nerves and muscles. Unfortunately, for those with very high levels of test related stress, the experience may be very frightening and may impede completion of the study and negatively impact on making a timely and accurate diagnosis. Several studies have shown that music can improve anxiety and pain levels in various situations and procedures. Our study will allow participants to play music of their choice during EMG and NCS in order to determine if the pain and anxiety that they experience is reduced.
Detailed description
This study will be a prospective randomized trial carried out at Mount Hope Centre for Long Term Care in London, Ontario. All patients referred for electromyography and a nerve conduction study will be considered for inclusion in the study. Those who meet the criteria and verbally consent to the study will sign a consent form and then be randomly assigned to either a music or no-music group using a computer-generated random number series. Prior to starting the test, all participants who enroll in the study will complete form Y-1 and Y-2 of the state-trait anxiety inventory (STAI) which measure state (S) anxiety and trait (T) anxiety respectively. They will also complete an 100 mm visual analogue scale (VAS) for pain and anxiety prior to beginning the studies. During and following the test they will be asked to complete a VAS for pain and anxiety, and the Y-1 of the STAI to measure state anxiety. Aside from having to fill out the STAI and visual analogue scales, patients assigned to the no-music group will undergo the EMG and NCS as per usual. Those in the music group will be given a set of over-ear headphones (sterilized before use) and a tablet device. Participants will be allowed to navigate Spotify, a digital music service to select whatever music they desire. An app that limits volume will be used to ensure that volume cannot be raised above 80 decibels by the patient. Communication with the patient will not be hindered as the EMG technician and physician will be speaking into a microphone that transmits the sound directly to the participant's headphones.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, intervention-control, trial
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: MusicPatients listen to music during EMG test |
| Control (Standard Care) | No intervention | –Patients do not listen to music during EMG test (ie. Standard of care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years of age or older referred for NCS and EMG at Mount Hope Centre for Long Term Care in London, Ontario will be eligible and offered entry into the study if the following criteria are met: the NCS/EMG are indicated, they have at least a 6th grade reading level in English such that they can complete the STAI, and the patient is willing and able to provide signed informed consent.
Key exclusion criteria (3 listed)
- Use of hearing aids that would preclude or hinder the use of over-ear headphones.
- Profound hearing loss.
- Cognitive Impairment
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 |
|---|---|---|
| MusicParticipants in this arm will listen to music during the EMG testing | Other | Music |
Primary outcome
State-trait anxiety inventory (STAI)
Time frame: Change in STAI (State sub-scale) from immediately before the EMG procedure, during the EMG procedure and immediately after EMG procedure
Anxiety inventory that measures both Trait (T) and State (S) anxiety. Each sub- scale (T and S) is measured from 20-80 and reported individually (not combined) with higher values indicating higher anxiety. The typical cut off for S sub-scale is a score greater than 40 indicating clinically significant symptoms.
1 secondary outcome
Visual analog scale (VAS) for pain and anxiety scale (0-100)
Time frame: Change in VAS immediately before the EMG procedure, during the EMG procedure, and immediately after EMG procedure
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 17 Sep 2026.
- 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.
Steven Macaluso, M.D. principal investigator
Schulich School of Medicine and Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Anxiety and Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 17 Sep 2026. 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 Canada. 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?
State-trait anxiety inventory (STAI) (time frame: Change in STAI (State sub-scale) from immediately before the EMG procedure, during the EMG procedure and immediately after EMG procedure). 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 17 Sep 2026.