NCT01835275

Brief Summary

The purpose of this study is to determine whether enhanced audio methods can be used to improve analgesia for experimental pain in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2012

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

June 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2013

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

March 29, 2013

Last Update Submit

March 10, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity and Unpleasantness

    0-100 Visual Analog Scales to rate subjective pain intensity and unpleasentness

    1.5 hour testing session

Study Arms (3)

Music conditioning

EXPERIMENTAL

Subjects are tested with music, sound, and silence, after conditioning to enhance music induced analgesia

Behavioral: Enhanced AudioBehavioral: Audio

Sound

ACTIVE COMPARATOR

Subjects are tested with music, sound, and silence, after conditioning to enhance sound induced analgesia

Behavioral: Enhanced AudioBehavioral: Audio

Calibration

NO INTERVENTION

Subjects are tested with music, sound, and silence, with no enhanced audio received

Interventions

Enhanced AudioBEHAVIORAL
Music conditioningSound
AudioBEHAVIORAL
Music conditioningSound

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Mass General Hospital

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (1)

  • Hsieh C, Kong J, Kirsch I, Edwards RR, Jensen KB, Kaptchuk TJ, Gollub RL. Well-loved music robustly relieves pain: a randomized, controlled trial. PLoS One. 2014 Sep 11;9(9):e107390. doi: 10.1371/journal.pone.0107390. eCollection 2014.

    PMID: 25211164DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD PhD

Study Record Dates

First Submitted

March 29, 2013

First Posted

April 18, 2013

Study Start

June 1, 2012

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

March 14, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)