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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yu-Cheng Pei, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01531400
First received: January 29, 2012
Last updated: March 18, 2012
Last verified: March 2012
History of Changes
  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: 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:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Pain (Visual Analogue Scale) [ Time Frame: baseline and after needle electromyography, to measure the "change" of pain ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety, assessed by Linear Analogue Anxiety Scale (LAAS) [ Time Frame: baseline and after electromyography ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 29, 2012
Last Updated: March 18, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013