The Effect of Preferred Music on EMG Anxiety and Pain
Primary Purpose
Anxiety, Pain, Nerve Injury
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Music
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety
Eligibility Criteria
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:
- Use of hearing aids that would preclude or hinder the use of over-ear headphones.
- Profound hearing loss.
- Cognitive Impairment
Sites / Locations
- Mount Hope EMG Lab, St. Joseph's Health Care (SJHC)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music
Control (Standard Care)
Arm Description
Patients listen to music during EMG test
Patients do not listen to music during EMG test (ie. Standard of care)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03610503
First Posted
July 12, 2018
Last Updated
March 13, 2019
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03610503
Brief Title
The Effect of Preferred Music on EMG Anxiety and Pain
Official Title
The Effect of Preferred Music on Anxiety and Pain in Electrodiagnostic Studies: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain, Nerve Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, intervention-control, trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Anonymous data collection to be reviewed
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Music
Arm Type
Experimental
Arm Description
Patients listen to music during EMG test
Arm Title
Control (Standard Care)
Arm Type
No Intervention
Arm Description
Patients do not listen to music during EMG test (ie. Standard of care)
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
Participants in this arm will listen to music during the EMG testing
Primary Outcome Measure Information:
Title
State-trait anxiety inventory (STAI)
Description
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.
Time Frame
Change in STAI (State sub-scale) from immediately before the EMG procedure, during the EMG procedure and immediately after EMG procedure
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS) for pain and anxiety scale (0-100)
Description
Pain and anxiety scale using a standard VAS (0 = No pain/anxiety, 100 = maximal).
Time Frame
Change in VAS immediately before the EMG procedure, during the EMG procedure, and immediately after EMG procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Use of hearing aids that would preclude or hinder the use of over-ear headphones.
Profound hearing loss.
Cognitive Impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Macaluso, M.D.
Phone
5196854292
Ext
45062
Email
steven.macaluso@sjhc.london.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Macaluso, M.D.
Organizational Affiliation
Schulich School of Medicine and Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Hope EMG Lab, St. Joseph's Health Care (SJHC)
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Miller, M.D.
Phone
6196854292
Email
tom.miller@sjhc.london.on.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Preferred Music on EMG Anxiety and Pain
We'll reach out to this number within 24 hrs