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CompletedNCT01835275Updated Mar 14, 2016

Audio-enhanced Analgesia in Healthy Subjects

An interventional study of Enhanced Audio and Audio in Healthy, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-14.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18-50 years old
  • Healthy

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralEnhanced Audio
  • BehavioralAudio
06

What researchers measure

Primary outcomes

  1. Pain Intensity and Unpleasantness

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

    Time frame: 1.5 hour testing session

07

Study locations

1 site
  • Department of Psychiatry, Mass General Hospital
    Charlestown, Massachusetts 02129, United States
08

References and documents

Publications

  • 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. PubMed 25211164 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01835275
Lead sponsor
Massachusetts General Hospital
Responsible party
Randy L. Gollub (Associate Professor, MD PhD, Massachusetts General Hospital) — Principal investigator
First posted
Apr 18, 2013
Start date
Jun 2012
Primary completion
Jan 2013
Completion
Apr 2013
Last update
Mar 14, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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