Investigation of Pain and Anxiety During Electrodiagnosti... | NCT01531400

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

NCT01531400

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Mar 20, 2012Estimated

Enrollment

61Actual

Phase

Not Applicable

Conditions

Pain
Anxiety

Interventions

self-selected music

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2002

Primary Completion Date

Nov 2005Actual

Completion Date

Nov 2005Actual

First Submitted Date

Jan 29, 2012

First Submission Date that Met QC Criteria

Feb 10, 2012

First Posted Date

Feb 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yu-Cheng Pei, Principle Investigator (Attending physician and clinical assistant professor), Chang Gung Memorial HospitalPrincipal Investigator

Lead Sponsor

Chang Gung Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
music	Experimental	Investigators played self-selected background music in the music group	Other: self-selected music
no music (control)	No Intervention	Investigators played no music in the music group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
self-selected music	Other	Investigators played self-selected background music in the music group	music

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain (Visual Analogue Scale)		baseline and after needle electromyography, to measure the "change" of pain

Secondary Outcomes

Measure	Description	Time Frame
Anxiety, assessed by Linear Analogue Anxiety Scale (LAAS)		baseline and after electromyography

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yu-Cheng Pei, MD PhD	Attending Physician	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial Hospital		Taoyuan County		333	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided