Elective SurgeryPEPONCT00795392
Preoperative Psychological Evaluation as Predictor of Outcomes
An observational study of Elective Surgery, run by Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Elective Surgery
- What is being tested?
- ASA scale and Full-scale psychological assessment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2008to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All types of patients undergoing surgical operations
Who may be able to join
- Patients undergoing elective surgical operation
- Age from 18-65 years
Who cannot join
- Age <18 years or >65 years
- Not willing to participate in this study
- Patients from emergency department
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: 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.
- Conditions
- Elective Surgery
- Being tested
- ASA scale, Full-scale psychological assessment
- Keywords
- Psychology, Postoperative outcome, Surgical Operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASA scaleOther
ASA scale evaluation before operation
Full-scale psychological assessmentOther
Full-scale psychological evaluation before operation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients assessed with ASA physical status scale Receives: Other: ASA scale | |
| 2 | Patients assessed with full-scale psychological factors Receives: Other: Full-scale psychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of recovery
Measured: Since the end of the operation (1 day) to six-month follow-up.
Secondary outcomes (3)
Intraoperative consumption of drugs
Measured: 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
Measured: Time length of staying at hospital from the day of inpatient to discharge home, this time will undergo alteration in different individuals
Life quality
Measured: Since the end of the operation (1 day) to six-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective SurgeryStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795392
- Sponsor's protocol ID
- NJMU200811010
- Other IDs
- NJFY0811008
- Acronym
- PEPO
- Status last verified
- Sep 2009
- First submitted
- 20 Nov 2008
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Psychological Evaluation as Predictor of Post-surgical Outcomes
- ClinicalTrials.gov ID
- NCT00795392
- Acronym / sponsor ID
- PEPO / NJMU200811010
- Conditions
- Elective Surgery
- Keywords
- Psychology, Postoperative outcome, Surgical Operation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: ASA scalePatients assessed with ASA physical status scale |
| 2 | – | Other: Full-scale psychological assessmentPatients assessed with full-scale psychological factors |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All types of patients undergoing surgical operations
Key inclusion criteria (2 listed)
- Patients undergoing elective surgical operation
- Age from 18-65 years
Key exclusion criteria (3 listed)
- Age <18 years or >65 years
- Not willing to participate in this study
- Patients from emergency department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASA scaleASA scale evaluation before operation | Other | 1 |
| Full-scale psychological assessmentFull-scale psychological evaluation before operation | Other | 2 |
Primary outcome
Time of recovery
Time frame: Since the end of the operation (1 day) to six-month follow-up.
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoFeng Shen, MD study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Surgery, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of recovery (time frame: Since the end of the operation (1 day) to six-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2009.