Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music
This study has been completed.
Sponsor:
Chang Gung Memorial Hospital
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
| Tracking Information | |||||
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| First Received Date ICMJE | January 29, 2012 | ||||
| Last Updated Date | March 18, 2012 | ||||
| Start Date ICMJE | December 2002 | ||||
| Primary Completion Date | November 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pain (Visual Analogue Scale) [ Time Frame: baseline and after needle electromyography, to measure the "change" of pain ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01531400 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Anxiety, assessed by Linear Analogue Anxiety Scale (LAAS) [ Time Frame: baseline and after electromyography ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music | ||||
| Official Title ICMJE | Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music | ||||
| Brief Summary | The investigators hypothesized that self-selected music played during electrodiagnosis is effective in relieving the discomfort caused by the procedures. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | Other: self-selected music
Investigators played self-selected background music in the music group
Other Name: self-selected background music |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 61 | ||||
| Completion Date | November 2005 | ||||
| Primary Completion Date | November 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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:
Exclusion Criteria: The exclusion criteria are:
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| Gender | Both | ||||
| Ages | 15 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01531400 | ||||
| Other Study ID Numbers ICMJE | cgmhpmr001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Yu-Cheng Pei, Chang Gung Memorial Hospital | ||||
| Study Sponsor ICMJE | Chang Gung Memorial Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Chang Gung Memorial Hospital | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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