Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT03610503
Brief Summary:
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.
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:
NCT03610503
Study Brief:
Protocol Section:
NCT03610503