Audio Recording for Improved Surgical Outcome (ARISO)
May 21, 2015 updated by: James H. Stewart, M.D., Mayo Clinic
Audio Recording for Improved Surgical Outcome
Use of audio recordings (with suggestions and imagery for a better surgical outcome) studied in orthopedic patients.
Study Overview
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: A/B/C
Patients are randomized to voice/music/ or no CD
|
Using audio recording to investigate if possitive affirmations help with pain management and other post of compllication.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Post Op pain
Time Frame: Day 1 to 3
|
Day 1 to 3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood Loss, Nausea, sleep
Time Frame: Day 1 to Day 3
|
Day 1 to Day 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James H. Stewart, M.D., Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (ACTUAL)
July 1, 2009
Study Completion (ACTUAL)
July 1, 2009
Study Registration Dates
First Submitted
December 6, 2007
First Submitted That Met QC Criteria
December 7, 2007
First Posted (ESTIMATE)
December 10, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
May 22, 2015
Last Update Submitted That Met QC Criteria
May 21, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-002226
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.