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Audio Recording for Improved Surgical Outcome (ARISO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00569933
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : May 22, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
Use of audio recordings (with suggestions and imagery for a better surgical outcome) studied in orthopedic patients.

Condition or disease Intervention/treatment Phase
Osteoarthritis Behavioral: Audio recording Phase 1

Detailed Description:
Pt undergoing orthopedic surgery are randomized into 3 groups. These interventionals will be listening to CD recording just prior to and during orthopedic surgery. The 2nd group will be listening to a recording before and during surgery without any positive suggestions. The 3rd group will be receiving usual care. Prior to hospital discharge patients will fill out a questionaire assessing their perception of their surgery and hospital stay. Pt. charts will be reviewed for use of pain, sleep, anesthesia and nausea medication and for the number of units of blood transfused. Pt. outcomes will be asssessed with this data.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Audio Recording for Improved Surgical Outcome
Study Start Date : December 2007
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Patients are randomized to voice/music/ or no CD
Behavioral: Audio recording
Using audio recording to investigate if possitive affirmations help with pain management and other post of compllication.

Outcome Measures

Primary Outcome Measures :
  1. Post Op pain [ Time Frame: Day 1 to 3 ]

Secondary Outcome Measures :
  1. Blood Loss, Nausea, sleep [ Time Frame: Day 1 to Day 3 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients scheduled for total hip replacement under reginal anethesia at Mayo Clinic in Jacksonville, Fl.
  • Willingness to sign consent.
  • Age 18 or greater.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569933

United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: James H. Stewart, M.D. Mayo Clinic
More Information

Additional Information:
Responsible Party: James H. Stewart, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00569933     History of Changes
Other Study ID Numbers: 06-002226
First Posted: December 10, 2007    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

Keywords provided by James H. Stewart, M.D., Mayo Clinic:
Hip Surgery

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases