Back to resultsInvestigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music
Primary Purpose
Pain, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
self-selected music
Sponsored by
About this trial
This is an interventional supportive care trial for Pain
Eligibility 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.
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
music
no music (control)
Arm Description
Investigators played self-selected background music in the music group
Investigators played no music in the music group
Outcomes
Primary Outcome Measures
Pain (Visual Analogue Scale)
Secondary Outcome Measures
Anxiety, assessed by Linear Analogue Anxiety Scale (LAAS)
Full Information
NCT ID
NCT01531400
First Posted
January 29, 2012
Last Updated
March 18, 2012
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01531400
Brief Title
Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music
Official Title
Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesized that self-selected music played during electrodiagnosis is effective in relieving the discomfort caused by the procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
music
Arm Type
Experimental
Arm Description
Investigators played self-selected background music in the music group
Arm Title
no music (control)
Arm Type
No Intervention
Arm Description
Investigators played no music in the music group
Intervention Type
Other
Intervention Name(s)
self-selected music
Other Intervention Name(s)
self-selected background music
Intervention Description
Investigators played self-selected background music in the music group
Primary Outcome Measure Information:
Title
Pain (Visual Analogue Scale)
Time Frame
baseline and after needle electromyography, to measure the "change" of pain
Secondary Outcome Measure Information:
Title
Anxiety, assessed by Linear Analogue Anxiety Scale (LAAS)
Time Frame
baseline and after electromyography
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Cheng Pei, MD PhD
Organizational Affiliation
Attending Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
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Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music
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