Audio Recording for Improved Surgical Outcome (ARISO)
| Tracking Information | |||||
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| First Received Date ICMJE | December 6, 2007 | ||||
| Last Updated Date | August 14, 2009 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Post Op pain [ Time Frame: Day 1 to 3 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Post op pain | ||||
| Change History | Complete list of historical versions of study NCT00569933 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Blood Loss, Nausea, sleep [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Audio Recording for Improved Surgical Outcome (ARISO) | ||||
| Official Title ICMJE | Audio Recording for Improved Surgical Outcome | ||||
| Brief Summary | Use of audio recordings (with suggestions and imagery for a better surgical outcome) studied in orthopedic patients. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Osteoarthritis | ||||
| Intervention ICMJE | Behavioral: Audio recording
Using audio recording to investigate if possitive affirmations help with pain management and other post of compllication. |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00569933 | ||||
| Other Study ID Numbers ICMJE | 06-002226 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | James Stewart, MD, Mayo Clinic | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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