NCT01531400

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Dec 2002

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 13, 2012

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

2.9 years

First QC Date

January 29, 2012

Last Update Submit

March 18, 2012

Conditions

PainAnxiety

Outcome Measures

Primary Outcomes (1)

  • Pain (Visual Analogue Scale)

    baseline and after needle electromyography, to measure the "change" of pain

Secondary Outcomes (1)

  • Anxiety, assessed by Linear Analogue Anxiety Scale (LAAS)

    baseline and after electromyography

Study Arms (2)

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

self-selected musicOTHER

Investigators played self-selected background music in the music group

Also known as: self-selected background music
music

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • adult patient with working diagnosis of possible neurological disorder and
  • is referred for both nerve conduction study and needle electromyography

You may not qualify if:

  • conscious disturbances,
  • cognitive impairment, or
  • language dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Yu-Cheng Pei, MD PhD

    Attending Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator (Attending physician and clinical assistant professor)

Study Record Dates

First Submitted

January 29, 2012

First Posted

February 13, 2012

Study Start

December 1, 2002

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

TW(1)