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Preoperative Psychological Evaluation as Predictor of Outcomes (PEPO)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00795392
First received: November 20, 2008
Last updated: September 17, 2009
Last verified: September 2009
History of Changes
  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. ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Life quality [ Time Frame: Since the end of the operation (1 day) to six-month follow-up. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00795392     History of Changes
Other Study ID Numbers: NJMU200811010, NJFY0811008
Study First Received: November 20, 2008
Last Updated: September 17, 2009
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013