NCT00569933

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

1.6 years

First QC Date

December 6, 2007

Last Update Submit

May 21, 2015

Conditions

Osteoarthritis

Keywords

Hip SurgeryPerioperativesuggestions/imagery

Outcome Measures

Primary Outcomes (1)

  • Post Op pain

    Day 1 to 3

Secondary Outcomes (1)

  • Blood Loss, Nausea, sleep

    Day 1 to Day 3

Study Arms (1)

A/B/C

OTHER

Patients are randomized to voice/music/ or no CD

Behavioral: Audio recording

Interventions

Audio recordingBEHAVIORAL

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

A/B/C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for total hip replacement under reginal anethesia at Mayo Clinic in Jacksonville, Fl.
  • Willingness to sign consent.
  • Age 18 or greater.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Sound Recordings

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Audiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and Agriculture

Study Officials

  • James H. Stewart, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 10, 2007

Study Start

December 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

US(1)