NCT00103870

Brief Summary

The purpose of this study is to determine whether engaging in music listening tasks can reduce the perception of pain and provide nondrug pain relief. Study hypotheses: 1) Performing a highly engaging listening task reduces psychophysiological arousal to painful stimuli. 2) Psychophysiological arousal to painful stimuli is a function of the complexity of the auditory signal. 3) Signal complexity and task difficulty interact to produce the greatest engagement and maximum reduction in psychophysiological arousal to painful stimuli.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1 pain

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_1 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

December 9, 2009

Status Verified

December 1, 2009

Enrollment Period

3.1 years

First QC Date

February 15, 2005

Last Update Submit

December 8, 2009

Conditions

Pain

Keywords

Music TherapyElectric StimulationElectric ShockAnalgesicsDistraction

Outcome Measures

Primary Outcomes (1)

  • Reduction in psychophysiological markers for nociceptive responses

Secondary Outcomes (1)

  • Level of engagement as measured by engagement ratings and absorption scale

Interventions

Electrodermal stimulationPROCEDURE
Music listening taskPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to comply with all study requirements

You may not qualify if:

  • Abnormal hearing
  • Severe allergies to skin preparations
  • Psychoactive drugs
  • Hypertension drugs
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Pain Research Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David H. Bradshaw, PhD

    University of Utah Pain Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2005

First Posted

February 16, 2005

Study Start

February 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

December 9, 2009

Record last verified: 2009-12

Locations

US(1)