Preoperative Psychological Evaluation as Predictor of Outcomes - Full Text View

Sponsored by:	Nanjing Medical University
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00795392

Purpose

Perioperative psychological care is increasingly recognized as an essential part in 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
Surgical Operation	Other: ASA scale Other: Full-scale psychological assessment

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, 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 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 to the end of the surgical procedures ] [ Designated as safety issue: Yes ]
Hospitalization days [ Time Frame: Time length of staying at hospital from the day of inpatient to discharge home ] [ Designated as safety issue: No ]
Life quality [ Time Frame: Since the end of the operation to six-month follow-up. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	November 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 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

Contacts

Contact: FuZhou Wang, MD	86-25-84460777 ext 3301	zfwang50@gmail.com
Contact: ShiQin Xu, MD	86-25-84460777 ext 3301	xushiqin521@sina.com

Locations

China, Jiangsu
Nanjing Maternal and Child Health Care Hospital	Recruiting
Nanjing, Jiangsu, China, 210004
Contact: YuZhu Peng, MD 86-25-84460777 ext 1508 pyz1131@hotmail.com
Contact: XiRong Guo, MD 86-25-84460777 ext 1508 xrguonjmueducn@yahoo.com.cn
Sub-Investigator: YuSheng Liu, MD

Sponsors and Collaborators

Nanjing Medical University

Investigators

Study Director:

XiaoFeng Shen, MD

Nanjing Medical University

More Information

Responsible Party:	Nanjing Medical University ( XiaoFeng Shen )
Study ID Numbers:	NJMU200811010, NJFY0811008
Study First Received:	November 20, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00795392
Health Authority:	China: Ethics Committee

Keywords provided by Nanjing Medical University:

Psychology
Postoperative outcome

ClinicalTrials.gov processed this record on January 14, 2009