Lumbosacral RadiculopathyNCT07026487
Evaluation of The Effect of Music Therapy on Fear of Needle Electromyography
A study testing Music intervention in people with Lumbosacral Radiculopathy, run by TC Erciyes University.
Trial summary
Electroneuromyography (ENMG) is a frequently employed methodology in the diagnosis and monitoring of neuromuscular disorders. It encompasses two principal components: nerve conduction studies (NCS) and needle electromyography (EMG). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- Music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 years referred to the Electroneuromyography Unit with a prediagnosis of lumbosacral radiculopathy
- Patients whose cognitive status is sufficient to complete the study and who can be co-operated with
Who cannot join
- Individuals with hearing impairment and/or the use of hearing aids
- Patients with a history of significant neurological or psychiatric illness.
- Patients with cognitive impairment
- Patients with a diagnosis of polyneuropathy.
- Patients receiving pharmacological agents that affect the pain state, including analgesics, antidepressants, and other medications.
- Individuals who have previously undergone electrodiagnostic studies.
- Individuals with contraindications for needle EMG, including those with bleeding disorders, anticoagulant use, or active infection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Electroneuromyography (ENMG) is a frequently employed methodology in the diagnosis and monitoring of neuromuscular disorders. It encompasses two principal components: nerve conduction studies (NCS) and needle electromyography (EMG). While NST is conducted with the application of electrical stimulation, which may result in mild discomfort, needle EMG is employed for the examination of muscle electrical activity. It is acknowledged that the procedure may cause discomfort, anxiety and fear in patients, which may have an adverse effect on the test results. A variety of methods have been proposed to mitigate discomfort, including oral ibuprofen, cognitive therapy, and topical agents. Music therapy has demonstrated efficacy in alleviating anxiety and pain during numerous medical procedures; however, its impact on pain and anxiety during needle EMG remains unexplored. This study aims to examine the influence of music therapy on pain and anxiety in individuals undergoing needle EMG. To this end, the effects of needle EMG and music therapy on pain and anxiety will be contrasted in two distinct groups.
Read the detailed description
The objective of this study was to include 58 patients who had been referred to the Erciyes University Faculty of Medicine, Physical Medicine and Rehabilitation, Electroneurophysiology Unit with a prediagnosis of lumbosacral radiculopathy. Following the provision of written informed consent, patients who have agreed to participate in the study will be included. Following the assessment of the inclusion and exclusion criteria, the demographic data of the eligible patients (gender, age, weight, height, body mass index, marital status, occupation, education level) will be recorded on the patient evaluation form.
A comprehensive inquiry will be conducted into the patients' backgrounds, including their medication history, surgical history, preexisting medical conditions, and habits such as smoking and alcohol consumption. Subsequently, the patients will be randomly assigned to either the music treatment group or the control group. In the music group, patients will be provided with the option of listening to a range of relaxing instrumental music, including classical, original, Spanish, jazz, and mystical genres, throughout the EMG procedure. In the control group, no additional procedures will be conducted beyond the routine. To ensure consistency and accuracy, all patients will undergo the same set of measurements before and after the procedure, including the duration of the test, systolic and diastolic blood pressure, and pulse per minute.
The patient's perception of pain during the procedure will be evaluated using the visual analogue scale (VAS), and the State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety Depression Scale (HAD) questionnaires will be completed to assess anxiety levels. Additionally, the level of satisfaction with the procedure, the willingness to undergo the procedure again in the future, the degree of anxiety experienced during the procedure, and the perceived difficulty of the procedure by the physician performing it will be evaluated using a visual analogue scale (VAS) with a range of 0 to 10 points.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- Music intervention
- Keywords
- needle emg, music therapy, electromyography, fear of needle EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
This group will receive music therapy while performing Needle EMG
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Music therapy will not be given during needle EMG |
| Music Group | Experimental | This group will receive music therapy during needle EMG. Receives: Other: Music intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
The patient's perception of pain during the procedure will be assessed with the visual analogue scale (VAS) The degree of satisfaction of the patients with the procedure, their willingness to repeat the procedure in the future, the degree of anxiety during the procedure, and the perceived degree of difficulty in the procedure by the physician performing the procedure will be evaluated with VAS between 0 and 10 points.
Measured: degree of pain during needle EMG, degree of satisfaction with the procedure during needle emg, Whether they are willing to repeat the procedure in the future after needle EMG, anxiety about the procedure: before, during and immediately after procedure
State-Trait Anxiety Inventory (STAI)
Measured: before and immediately after procedure
Beck Anxiety Inventory
Measured: before and immediately after procedure
Hospital Anxiety and Depression Scale
Measured: before and immediately after procedure
Systolic-Diastolic Blood pressure
Measured: before, during and immediately after procedure
Pulse rate
Measured: before, during and immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start25 Jun 2025 (estimated)
- Primary completion25 Aug 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral RadiculopathyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will consist of two groups. Intervention group: group receiving treatment with music Control group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Kara, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026487
- Sponsor's protocol ID
- HKara4
- Status last verified
- Jun 2025
- First submitted
- 16 Oct 2024
- Last updated
- 18 Jun 2025
- 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Music Therapy on Fear of Needle Electromyography
- ClinicalTrials.gov ID
- NCT07026487
- Acronym / sponsor ID
- HKara4
- Conditions
- Lumbosacral Radiculopathy
- Keywords
- needle emg, music therapy, electromyography, fear of needle EMG
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 18 Jun 2025 (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.
Electroneuromyography (ENMG) is a frequently employed methodology in the diagnosis and monitoring of neuromuscular disorders. It encompasses two principal components: nerve conduction studies (NCS) and needle electromyography (EMG). While NST is conducted with the application of electrical stimulation, which may result in mild discomfort, needle EMG is employed for the examination of muscle electrical activity. It is acknowledged that the procedure may cause discomfort, anxiety and fear in patients, which may have an adverse effect on the test results. A variety of methods have been proposed to mitigate discomfort, including oral ibuprofen, cognitive therapy, and topical agents. Music therapy has demonstrated efficacy in alleviating anxiety and pain during numerous medical procedures; however, its impact on pain and anxiety during needle EMG remains unexplored. This study aims to examine the influence of music therapy on pain and anxiety in individuals undergoing needle EMG. To this end, the effects of needle EMG and music therapy on pain and anxiety will be contrasted in two distinct groups.
Detailed description
The objective of this study was to include 58 patients who had been referred to the Erciyes University Faculty of Medicine, Physical Medicine and Rehabilitation, Electroneurophysiology Unit with a prediagnosis of lumbosacral radiculopathy. Following the provision of written informed consent, patients who have agreed to participate in the study will be included. Following the assessment of the inclusion and exclusion criteria, the demographic data of the eligible patients (gender, age, weight, height, body mass index, marital status, occupation, education level) will be recorded on the patient evaluation form.
A comprehensive inquiry will be conducted into the patients' backgrounds, including their medication history, surgical history, preexisting medical conditions, and habits such as smoking and alcohol consumption. Subsequently, the patients will be randomly assigned to either the music treatment group or the control group. In the music group, patients will be provided with the option of listening to a range of relaxing instrumental music, including classical, original, Spanish, jazz, and mystical genres, throughout the EMG procedure. In the control group, no additional procedures will be conducted beyond the routine. To ensure consistency and accuracy, all patients will undergo the same set of measurements before and after the procedure, including the duration of the test, systolic and diastolic blood pressure, and pulse per minute.
The patient's perception of pain during the procedure will be evaluated using the visual analogue scale (VAS), and the State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety Depression Scale (HAD) questionnaires will be completed to assess anxiety levels. Additionally, the level of satisfaction with the procedure, the willingness to undergo the procedure again in the future, the degree of anxiety experienced during the procedure, and the perceived difficulty of the procedure by the physician performing it will be evaluated using a visual analogue scale (VAS) with a range of 0 to 10 points.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will consist of two groups. Intervention group: group receiving treatment with music Control group
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Music therapy will not be given during needle EMG |
| Music Group | Experimental | Other: Music interventionThis group will receive music therapy during needle EMG. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-70 years referred to the Electroneuromyography Unit with a prediagnosis of lumbosacral radiculopathy
- Patients whose cognitive status is sufficient to complete the study and who can be co-operated with
Key exclusion criteria (7 listed)
- Individuals with hearing impairment and/or the use of hearing aids
- Patients with a history of significant neurological or psychiatric illness.
- Patients with cognitive impairment
- Patients with a diagnosis of polyneuropathy.
- Patients receiving pharmacological agents that affect the pain state, including analgesics, antidepressants, and other medications.
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 |
|---|---|---|
| Music interventionThis group will receive music therapy while performing Needle EMG | Other | Music Group |
Primary outcome
Visual analogue scale (VAS)
Time frame: degree of pain during needle EMG, degree of satisfaction with the procedure during needle emg, Whether they are willing to repeat the procedure in the future after needle EMG, anxiety about the procedure: before, during and immediately after procedure
The patient's perception of pain during the procedure will be assessed with the visual analogue scale (VAS) The degree of satisfaction of the patients with the procedure, their willingness to repeat the procedure in the future, the degree of anxiety during the procedure, and the perceived degree of difficulty in the procedure by the physician performing the procedure will be evaluated with VAS between 0 and 10 points.
State-Trait Anxiety Inventory (STAI)
Time frame: before and immediately after procedure
Beck Anxiety Inventory
Time frame: before and immediately after procedure
Hospital Anxiety and Depression Scale
Time frame: before and immediately after procedure
Systolic-Diastolic Blood pressure
Time frame: before, during and immediately after procedure
Pulse rate
Time frame: before, during and immediately after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Lumbosacral Radiculopathy, run by TC Erciyes University.
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hasan Kara, Asistant Professor (+905552592665, drhasankara@yandex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: degree of pain during needle EMG, degree of satisfaction with the procedure during needle emg, Whether they are willing to repeat the procedure in the future after needle EMG, anxiety about the procedure: before, during and immediately after procedure). The study lists 6 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 18 Jun 2025.