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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01531400
First Posted: February 13, 2012
Last Update Posted: March 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yu-Cheng Pei, Chang Gung Memorial Hospital
  Purpose
The investigators hypothesized that self-selected music played during electrodiagnosis is effective in relieving the discomfort caused by the procedures.

Condition Intervention
Pain Anxiety Other: self-selected music

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music

Resource links provided by NLM:


Further study details as provided by Yu-Cheng Pei, Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Pain (Visual Analogue Scale) [ Time Frame: baseline and after needle electromyography, to measure the "change" of pain ]

Secondary Outcome Measures:
  • Anxiety, assessed by Linear Analogue Anxiety Scale (LAAS) [ Time Frame: baseline and after electromyography ]

Enrollment: 61
Study Start Date: December 2002
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: self-selected background music
No Intervention: no music (control)
Investigators played no music in the music group

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531400


Locations
Taiwan
Chang Gung Memorial Hospital
Taoyuan County, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Yu-Cheng Pei, MD PhD Attending Physician
  More Information

Responsible Party: Yu-Cheng Pei, Principle Investigator (Attending physician and clinical assistant professor), Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01531400     History of Changes
Other Study ID Numbers: cgmhpmr001
First Submitted: January 29, 2012
First Posted: February 13, 2012
Last Update Posted: March 20, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders