- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01550263
Psychological Distress and Outcomes in Hip Preservation Patients (Hip)
February 6, 2023 updated by: Stephen Aoki, University of Utah
Pre-Operative Psychological Distress and Post-Operative Outcomes in Hip Preservation Patients
This is an investigatory study to determine whether high levels of pre-operative psychological distress predict worse outcomes after hip preservation.
This is a low risk study and does not alter the treatment or course of care for patients undergoing this procedure
Study Overview
Status
Completed
Conditions
Detailed Description
The correlation between increasing psychological distress and worsening surgical outcomes has been extensively documented in patients undergoing spine surgery.
However, we have no reason to believe that patients with hip pathology are uniquely exempt from the influence of psychosocial factors.
To our knowledge, no study has been done to evaluate the effect of pre-operative psychological distress on outcomes after hip preservation surgery.
We therefore propose to use the DRAM to measure pre-operative distress in patients undergoing open or arthroscopic hip preservation surgery and to compare these pre-operative distress scores with post-operative outcomes.
We hope the information we gain will allow clinicians to comprehensively evaluate the patient with hip pain and to make more informed choices about operative treatment.
Study Type
Observational
Enrollment (Actual)
217
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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Utah
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Salt Lake City, Utah, United States, 84108
- Orthopaedic Center
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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
Sampling Method
Probability Sample
Study Population
Patients are selected by Dr. Aoki
Description
Inclusion Criteria:
- Primary presenting complaint of hip pain
- Hip arthroscopy, surgical dislocation and debridement, and/or periacetabular osteotomy performed by Dr. Aoki or Dr. Peters for hip pathology diagnosed by history, clinical examination and/or imaging
Exclusion Criteria:
- Unable to complete the DRAM questionnaire
- Patients who do not undergo surgery
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distress and Risk Assessment Method (DRAM) questionaire
Time Frame: 1 year
|
Distress and Risk Assessment Method (DRAM) questionaire to screen for psychological distress.
The instrument defines four categories based on patients responses: Type N (normal; lower scores, no evidence of distress); Type R (at risk; higher scores, primarily in symptoms of depression); Type DD (distressed-depressive; higher scores on all variables, but very high on depressive symptomatology); and Type DS (distressed-somatic; higher scores on all variables, but very high on somatic awareness).
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2012
Primary Completion (ACTUAL)
November 1, 2022
Study Completion (ACTUAL)
November 1, 2022
Study Registration Dates
First Submitted
February 8, 2012
First Submitted That Met QC Criteria
March 6, 2012
First Posted (ESTIMATE)
March 9, 2012
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 6, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 48948
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.
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