Audio Recording for Improved Surgical Outcome (ARISO) - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00569933

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 I

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Audio Recording for Improved Surgical Outcome

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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	Recruiting
Jacksonville, Florida, United States, 32224
Contact: Pamela K. Long 904-953-7719 long.pamela@mayo.edu
Principal Investigator: James H. Stewart, M.D.

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

James H. Stewart, M.D.

Mayo Clinic

More Information

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Responsible Party:	Mayo Clinic ( James Stewart, MD )
Study ID Numbers:	06-002226
Study First Received:	December 6, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00569933
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Hip Surgery
Perioperative
suggestions/imagery

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 15, 2009