Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music

March 18, 2012 updated by: Yu-Cheng Pei, Chang Gung Memorial Hospital
The investigators hypothesized that self-selected music played during electrodiagnosis is effective in relieving the discomfort caused by the procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan County, Taiwan, 333
        • Chang Gung memorial hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Investigators recruited volunteer patient participants from patients referred to the electrodiagnosis laboratory of Department of Physical Medicine and Rehabilitation in a medical center using convenient sampling.

The inclusion criterion is:

  • adult patient with working diagnosis of possible neurological disorder and
  • is referred for both nerve conduction study and needle electromyography

Exclusion Criteria:

The exclusion criteria are:

  • conscious disturbances,
  • cognitive impairment, or
  • language dysfunction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: music
Investigators played self-selected background music in the music group
Other: self-selected music
Investigators played self-selected background music in the music group
Other Names:
  • self-selected background music
No Intervention: no music (control)
Investigators played no music in the music group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain (Visual Analogue Scale)
Time Frame: baseline and after needle electromyography, to measure the "change" of pain
baseline and after needle electromyography, to measure the "change" of pain

Secondary Outcome Measures

Outcome Measure
Time Frame
Anxiety, assessed by Linear Analogue Anxiety Scale (LAAS)
Time Frame: baseline and after electromyography
baseline and after electromyography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Yu-Cheng Pei, MD PhD, Attending Physician

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

January 29, 2012

First Submitted That Met QC Criteria

February 10, 2012

First Posted (Estimate)

February 13, 2012

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 18, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cgmhpmr001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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