- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00795392
Preoperative Psychological Evaluation as Predictor of Outcomes (PEPO)
September 17, 2009 updated by: Nanjing Medical University
Preoperative Psychological Evaluation as Predictor of Post-surgical Outcomes
Perioperative psychological care is increasingly recognized as an essential part in the surgical environment.
Previous studies have developed a strategy to evaluate the psychological influence after operations and found that postoperative psychological states significantly associated with the outcomes of patients.
However, preoperative evaluation of patients the physicians do thus far is mainly the physical status assessment following the scale of American Society of Anesthesiologists (ASA).
Whether a full-scale evaluation of preoperative psychological status to surgical patients could be a predictor to postoperative outcomes or not is not still completely understood.
The investigators hypothesized that the preoperative psychological assessment would be an important predictor to outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
200
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
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210004
- Nanjing Maternal and Child Health Care Hospital
-
-
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 to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All types of patients undergoing surgical operations
Description
Inclusion Criteria:
- Patients undergoing elective surgical operation
- Age from 18-65 years
Exclusion Criteria:
- Age <18 years or >65 years
- Not willing to participate in this study
- Patients from emergency department
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Patients assessed with ASA physical status scale
|
ASA scale evaluation before operation
|
2
Patients assessed with full-scale psychological factors
|
Full-scale psychological evaluation before operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time of recovery
Time Frame: Since the end of the operation (1 day) to six-month follow-up.
|
Since the end of the operation (1 day) to six-month follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intraoperative consumption of drugs
Time Frame: From the time of start of operation (0 min) to the end of the surgical procedures, this time will undergo alteration in different individuals
|
From the time of start of operation (0 min) to the end of the surgical procedures, this time will undergo alteration in different individuals
|
Hospitalization days
Time Frame: Time length of staying at hospital from the day of inpatient to discharge home, this time will undergo alteration in different individuals
|
Time length of staying at hospital from the day of inpatient to discharge home, this time will undergo alteration in different individuals
|
Life quality
Time Frame: Since the end of the operation (1 day) to six-month follow-up.
|
Since the end of the operation (1 day) to six-month follow-up.
|
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
November 1, 2008
Primary Completion (ACTUAL)
September 1, 2009
Study Completion (ACTUAL)
September 1, 2009
Study Registration Dates
First Submitted
November 20, 2008
First Submitted That Met QC Criteria
November 20, 2008
First Posted (ESTIMATE)
November 21, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
September 18, 2009
Last Update Submitted That Met QC Criteria
September 17, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- NJMU200811010
- NJFY0811008
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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