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Audio Recording for Improved Surgical Outcome (ARISO)

This study has been completed.
Information provided by (Responsible Party):
James H. Stewart, M.D., Mayo Clinic Identifier:
First received: December 6, 2007
Last updated: May 21, 2015
Last verified: May 2015
Use of audio recordings (with suggestions and imagery for a better surgical outcome) studied in orthopedic patients.

Condition Intervention Phase
Osteoarthritis Behavioral: Audio recording Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Official Title: Audio Recording for Improved Surgical Outcome

Further study details as provided by James H. Stewart, M.D., Mayo Clinic:

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

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

Enrollment: 30
Study Start Date: December 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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
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Please refer to this study by its identifier: 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 Identifier: NCT00569933     History of Changes
Other Study ID Numbers: 06-002226
Study First Received: December 6, 2007
Last Updated: May 21, 2015

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

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on July 21, 2017