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Preoperative Psychological Evaluation as Predictor of Outcomes (PEPO)

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ClinicalTrials.gov Identifier: NCT00795392
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:
Nanjing Medical University

Tracking Information
First Submitted Date November 20, 2008
First Posted Date November 21, 2008
Last Update Posted Date September 18, 2009
Study Start Date November 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 17, 2009)
Time of recovery [ Time Frame: Since the end of the operation (1 day) to six-month follow-up. ]
Original Primary Outcome Measures
 (submitted: November 20, 2008)
Time of recovery [ Time Frame: Since the end of the operation to six-month follow-up. ]
Change History Complete list of historical versions of study NCT00795392 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 17, 2009)
  • 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 ]
  • 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 ]
  • Life quality [ Time Frame: Since the end of the operation (1 day) to six-month follow-up. ]
Original Secondary Outcome Measures
 (submitted: November 20, 2008)
  • Intraoperative consumption of drugs [ Time Frame: From the time of start of operation to the end of the surgical procedures ]
  • Hospitalization days [ Time Frame: Time length of staying at hospital from the day of inpatient to discharge home ]
  • Life quality [ Time Frame: Since the end of the operation to six-month follow-up. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Preoperative Psychological Evaluation as Predictor of Outcomes
Official Title Preoperative Psychological Evaluation as Predictor of Post-surgical Outcomes
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All types of patients undergoing surgical operations
Condition Elective Surgery
Intervention
  • Other: ASA scale
    ASA scale evaluation before operation
  • Other: Full-scale psychological assessment
    Full-scale psychological evaluation before operation
Study Groups/Cohorts
  • 1
    Patients assessed with ASA physical status scale
    Intervention: Other: ASA scale
  • 2
    Patients assessed with full-scale psychological factors
    Intervention: Other: Full-scale psychological assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 20, 2008)
200
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT00795392
Other Study ID Numbers NJMU200811010
NJFY0811008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party XiaoFeng Shen, Nanjing Medical University
Study Sponsor Nanjing Medical University
Collaborators Not Provided
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
PRS Account Nanjing Medical University
Verification Date September 2009