Audio Recording for Improved Surgical Outcome (ARISO)

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00569933
First received: December 6, 2007
Last updated: August 14, 2009
Last verified: August 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Audio Recording for Improved Surgical Outcome

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Post Op pain [ Time Frame: Day 1 to 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Loss, Nausea, sleep [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]

Estimated 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)
Intervention Details:
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569933

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

Additional Information:
No publications provided

Responsible Party: James Stewart, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00569933     History of Changes
Other Study ID Numbers: 06-002226
Study First Received: December 6, 2007
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Hip Surgery
Perioperative
suggestions/imagery

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014