Mind Engagement With Music for Nondrug Pain Relief

December 8, 2009 updated by: University of Utah

Music Engagement for Non-Pharmacological Analgesia R21 AT001586-01

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Music therapy involves the use of music to promote, maintain, and restore physical and mental health. Music analgesia is one aspect of music therapy focused on the reduction of pain through the use of musical activities. This study will build upon music analgesia data in the development of a new concept called music engagement. This concept is based on constructivist theory, which presumes that the brain continuously constructs and revises a model of reality. Pain is a constructed reality that may be prevented from being felt if a person is actively engaged in constructing another perceptual experience. Music listening is an activity that requires activation and integration of many complex cognitive and emotional processes; therefore, being actively engaged in music listening can impede the construction of pain if the listener can fully construct and sustain the music experience. This study will determine whether engagement in and construction of a music listening experience can reduce perceptions of pain.

This trial will comprise two studies and will require two days of participation. At study start, participants will have electrodes placed on a finger on their non-dominant hand and on other body parts to record skin conductance and electrical brain activity. Participants will also wear a headset to have their pupil movement measured. Tone synthesis software will be used to generate different tones. In Study 1, a familiar tune, selected by the participant, will be played against a background of varying tones. Occasionally, notes of the tune will be missing or displaced. Participants will be asked to identify the deviant notes while receiving painful fingertip shocks; they will be instructed to focus on the task and ignore the shocks. Study 1 will consist of three different conditions (easy, hard, and no condition). In the easy condition, the background tones occur far from the pitch range of the tune, making missing or displaced notes easy to detect. In the hard condition, the pitch range of the background tones will be adjacent to that of the tune, making the tune difficult to discern from the background tones. In the no task condition, participants will hear the familiar tune with random background tones, but they will be instructed to pay no attention to the tune or the tones.

Participants will report their pain experiences in both a retrospective report and a concurrent report. For the retrospective report, participants will report the highest, lowest, and average levels of pain experienced during the preceding block of trials. For the concurrent report, participants will give both a report of the level of pain experienced immediately following each shock episode. At each of the two sessions participants take part in, there will be two sets of trial blocks, one with pain reports and one without. There will be two blocks for each of the three music task conditions for a total of twelve blocks per session. Within each block, sixteen 7- to 11-second shocks will be given.

In Study 2, participants will take part in two types of listening tasks, one with only tones and one with both a tune and background tones. There will be three tasks in the tone condition (no task, easy task, and hard task). In the no task condition, participants will hear repeated tones; they will be instructed to pay no attention to the tones. In the easy condition, the deviant tones will be easily detectable; in the hard condition, they will be less detectable. During each condition, participants will receive painful fingertip shocks.

The second task condition is similar to Study 1; participants will listen to a familiar tune with various tones in the background. Participants will be given fingertip shocks and will be asked to identify deviant notes for both the easy and hard conditions. For the no task condition, participants will be instructed to pay no attention to the tune or background tones. Participants will not be required to report pain in this part of the study. Participants will receive two blocks of trials for each of the six task conditions. Fingertip shocks will vary in intensity with the interval between shocks varying between 7 and 11 seconds.

Pain self-reports (Study 1), deviant note detections, skin conductance, pupil dilation, and electroencephalogram changes following stimulations will be used to assess participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Pain Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing and able to comply with all study requirements

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Reduction in psychophysiological markers for nociceptive responses

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Level of engagement as measured by engagement ratings and absorption scale

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David H. Bradshaw, PhD, University of Utah Pain Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB 12579
  • R21AT001586-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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