The Effect of Preferred Music on EMG Anxiety and Pain

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Anxiety; Nerve Injury
• Intervention / Treatment: Other: Music

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 1Y6
      • Recruiting
      • Mount Hope EMG Lab, St. Joseph's Health Care (SJHC)
      • Contact: Tom Miller, M.D.; Phone Number: 6196854292; Email: tom.miller@sjhc.london.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. Use of hearing aids that would preclude or hinder the use of over-ear headphones.
2. Profound hearing loss.
3. Cognitive Impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Music; Patients listen to music during EMG test	Other: Music; Participants in this arm will listen to music during the EMG testing
NO_INTERVENTION: Control (Standard Care); Patients do not listen to music during EMG test (ie. Standard of care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change in STAI (State sub-scale) from immediately before the EMG procedure, during the EMG procedure and immediately after EMG procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Change in VAS immediately before the EMG procedure, during the EMG procedure, and immediately after EMG procedure

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Steven Macaluso, M.D., Schulich School of Medicine and Dentistry

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2018
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (ACTUAL): August 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: REDA 5189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No