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NCT Number: NCT07026487

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Music intervention

Other

This group will receive music therapy while performing Needle EMG

Primary outcomes

  1. 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.

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Hasan Kara, Asistant Professor

CONTACT

[email protected]

+905552592665

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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