Audio-enhanced Analgesia in Healthy Subjects

March 10, 2016 updated by: Randy L. Gollub, Massachusetts General Hospital
The purpose of this study is to determine whether enhanced audio methods can be used to improve analgesia for experimental pain in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Department of Psychiatry, Mass General Hospital

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

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-50 years old
  • Healthy

Exclusion Criteria:

  • Current diagnoses of psychiatric or neurological disorders or chronic pain
  • BDI-II score greater than 13
  • current or previous ear/nose/throat or hearing issues
  • prior participation in pain studies
  • previous advanced music training

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Music conditioning
Subjects are tested with music, sound, and silence, after conditioning to enhance music induced analgesia
Behavioral: Enhanced Audio
Behavioral: Audio
ACTIVE_COMPARATOR: Sound
Subjects are tested with music, sound, and silence, after conditioning to enhance sound induced analgesia
Behavioral: Enhanced Audio
Behavioral: Audio
NO_INTERVENTION: Calibration
Subjects are tested with music, sound, and silence, with no enhanced audio received

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity and Unpleasantness
Time Frame: 1.5 hour testing session
0-100 Visual Analog Scales to rate subjective pain intensity and unpleasentness
1.5 hour testing session

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

March 29, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (ESTIMATE)

April 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 14, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2012P000969

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Healthy

Clinical Trials on Enhanced Audio

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe