An Evaluation of Psychological Parameters That May Influe... | NCT01396694

Studies
An Evaluation of Psychological Parameters That May Influence the Outcome Following Arthroscopy and Arthroplasty for Temporomandibular Joint Surgery

NCT01396694

Sponsor

Emory University

Status

Completed

Last Update Posted

Feb 17, 2016Estimated

Enrollment

105Actual

Phase

Not provided

Conditions

Psychological Predictors

Interventions

Questionnaire

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jul 8, 2011

First Submission Date that Met QC Criteria

Jul 17, 2011

First Posted Date

Jul 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2016

Last Update Posted Date

Feb 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

All patients undergoing arthroscopy or arthroplasty for temporomandibular joint dysfunction will complete a psychological questionnaire prior to surgery. The 3 month outcomes including pain and function will be examined using regression analysis to identify psychological variables that may predict outcomes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
all		All patients requiring arthroscopy or arthroplasty	Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Questionnaire	all

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain	Pain will be recorded in a site specific matter (left and right TMJ) using a visual analogue scale	3 months

Secondary Outcomes

Measure	Description	Time Frame
Function	Function will be measured using the jaw function limitation scale which will assess overall jaw and masticatory function with a short well validated questionnaire	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

require arthroscopy or arthroplasty

Exclusion Criteria:

age less than 18 yrs
prior surgery
unable to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

18 yrs

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University		Atlanta	Georgia	30322	United States

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided