Audio Recording for Improved Surgical Outcome (ARISO)

NCT ID: NCT00569933

Last Updated: 2015-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-07-31

Brief Summary

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Use of audio recordings (with suggestions and imagery for a better surgical outcome) studied in orthopedic patients.

Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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A/B/C

Patients are randomized to voice/music/ or no CD

Group Type OTHER

Audio recording

Intervention Type BEHAVIORAL

Using audio recording to investigate if possitive affirmations help with pain management and other post of compllication.

Interventions

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Audio recording

Using audio recording to investigate if possitive affirmations help with pain management and other post of compllication.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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James H. Stewart, M.D.

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James H. Stewart, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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06-002226

Identifier Type: -

Identifier Source: org_study_id

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