NCT07026487

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2024

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

June 25, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

October 16, 2024

Last Update Submit

June 17, 2025

Conditions

Keywords

needle emgmusic therapyelectromyographyfear of needle EMG

Outcome Measures

Primary Outcomes (6)

  • 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.

    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)

    before and immediately after procedure

  • Beck Anxiety Inventory

    before and immediately after procedure

  • Hospital Anxiety and Depression Scale

    before and immediately after procedure

  • Systolic-Diastolic Blood pressure

    before, during and immediately after procedure

  • Pulse rate

    before, during and immediately after procedure

Study Arms (2)

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.

Other: Music intervention

Interventions

This group will receive music therapy while performing Needle EMG

Music Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Hasan Kara, Asistant Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: The study will consist of two groups. Intervention group: group receiving treatment with music Control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 16, 2024

First Posted

June 18, 2025

Study Start

June 25, 2025

Primary Completion

August 25, 2025

Study Completion

October 15, 2025

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share