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Preoperative Psychological Evaluation as Predictor of Outcomes (PEPO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795392
First Posted: November 21, 2008
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nanjing Medical University
  Purpose
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.

Condition Intervention
Elective Surgery Other: ASA scale Other: Full-scale psychological assessment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Preoperative Psychological Evaluation as Predictor of Post-surgical Outcomes

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Time of recovery [ Time Frame: Since the end of the operation (1 day) to six-month follow-up. ]

Secondary Outcome Measures:
  • 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. ]

Enrollment: 200
Study Start Date: November 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients assessed with ASA physical status scale
Other: ASA scale
ASA scale evaluation before operation
2
Patients assessed with full-scale psychological factors
Other: Full-scale psychological assessment
Full-scale psychological evaluation before operation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All types of patients undergoing surgical operations
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795392


Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00795392     History of Changes
Other Study ID Numbers: NJMU200811010
NJFY0811008
First Submitted: November 20, 2008
First Posted: November 21, 2008
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by Nanjing Medical University:
Psychology
Postoperative outcome
Surgical Operation


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