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Not yet recruitingNCT07026487Updated Jun 18, 2025

Evaluation of The Effect of Music Therapy on Fear of Needle Electromyography

An interventional study of Music intervention in Lumbosacral Radiculopathy, sponsored by TC Erciyes University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by TC Erciyes University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Lumbosacral Radiculopathy

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Keywords

  • needle emg
  • music therapy
  • electromyography
  • fear of needle EMG
03

In context

Radiculopathy

488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.

This study's planned enrollment of 58 is close to the median of 60 across 376 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients aged 18-70 years referred to the Electroneuromyography Unit with a prediagnosis of lumbosacral radiculopathy
  2. Patients whose cognitive status is sufficient to complete the study and who can be co-operated with

Exclusion criteria

Exclusion Criteria:

  1. Individuals with hearing impairment and/or the use of hearing aids
  2. Patients with a history of significant neurological or psychiatric illness.
  3. Patients with cognitive impairment
  4. Patients with a diagnosis of polyneuropathy.
  5. Patients receiving pharmacological agents that affect the pain state, including analgesics, antidepressants, and other medications.
  6. Individuals who have previously undergone electrodiagnostic studies.
  7. Individuals with contraindications for needle EMG, including those with bleeding disorders, anticoagulant use, or active infection.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (estimated)

Study arms

  • No intervention
    Control group

    Music therapy will not be given during needle EMG

  • Experimental
    Music Group

    This group will receive music therapy during needle EMG.

    Other: Music intervention

Interventions

  • OtherMusic intervention

    This group will receive music therapy while performing Needle EMG

06

What researchers measure

Primary outcomes

  1. 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.

    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

  2. State-Trait Anxiety Inventory (STAI)

    Time frame: before and immediately after procedure

  3. Beck Anxiety Inventory

    Time frame: before and immediately after procedure

  4. Hospital Anxiety and Depression Scale

    Time frame: before and immediately after procedure

  5. Systolic-Diastolic Blood pressure

    Time frame: before, during and immediately after procedure

  6. Pulse rate

    Time frame: before, during and immediately after procedure

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07026487
Lead sponsor
TC Erciyes University
Responsible party
Hasan Kara (assistant professor, TC Erciyes University) — Principal investigator
First posted
Jun 18, 2025
Start date
Jun 25, 2025 (estimated)
Primary completion
Aug 25, 2025 (estimated)
Completion
Oct 15, 2025 (estimated)
Last update
Jun 18, 2025

Study contacts

Hasan Kara, Asistant Professor
Contact
drhasankara@yandex.com
+905552592665

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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