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

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ClinicalTrials.gov Identifier: NCT01531400
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : March 20, 2012
Sponsor:
Information provided by (Responsible Party):
Yu-Cheng Pei, Chang Gung Memorial Hospital

Brief Summary:
The investigators hypothesized that self-selected music played during electrodiagnosis is effective in relieving the discomfort caused by the procedures.

Condition or disease Intervention/treatment Phase
Pain Anxiety Other: self-selected music Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
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
Study Start Date : December 2002
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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 Name: self-selected background music
No Intervention: no music (control)
Investigators played no music in the music group



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

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


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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.

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

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 Posted: February 13, 2012    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders