The Effect of Preferred Music on EMG Anxiety and Pain

NCT03610503 | Unknown

• 1 other identifier: REDA 5189
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain; Nerve Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual analog scale (VAS) for pain and anxiety scale (0-100)

  Change in VAS immediately before the EMG procedure, during the EMG procedure, and immediately after EMG procedure

Study Arms (2)

Music

EXPERIMENTAL

Patients listen to music during EMG test

Other: Music

Control (Standard Care)

NO INTERVENTION

Patients do not listen to music during EMG test (ie. Standard of care)

Interventions

Music OTHER

Participants in this arm will listen to music during the EMG testing

Music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Mount Hope EMG Lab, St. Joseph's Health Care (SJHC)

London, Ontario, N6A 1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Steven Macaluso, M.D.

  Schulich School of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Macaluso, M.D.

CONTACT

5196854292; steven.macaluso@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Anonymous data collection to be reviewed
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, intervention-control, trial

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 1, 2018
• Study Start: August 20, 2018
• Primary Completion: December 1, 2019
• Study Completion: August 1, 2020
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)