The Correlations Between Clinical Effect and Emotional State

December 6, 2017 updated by: Liu Chenjun, Peking University People's Hospital

Analysis of Correlations Between Preoperative Emotional State and Postoperative Clinical Effect in Patients Undergoing Lumbar Surgery

To analyze the correlations between preoperative emotional state and postoperative clinical effect among patients undergoing lumbar surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Preoperative emotional state and postoperative clinical effect of patients undergoing lumbar surgery will be evaluated and compared. Then the relations of anxiety and depression on quality of life will be analyzed.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients undergoing lumbar surgery for lumbar degenerative diseases with or without emotional state of anxiety and depression evaluated by emotional scales.

Description

Inclusion Criteria:

  1. patients with relevant symptoms of lumbar degenerative diseases;
  2. patients with bad emotional state,such as anxiety or depression.

Exclusion Criteria:

  1. spinal tumor;
  2. spinal trauma;
  3. congenital spinal disease;
  4. patients diagnosed psychosis;
  5. patients with incomplete clinical informations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
lumbar surgery patients
patients undergoing lumbar surgery with or without anxiety or depression emotional state
Other: emotional state
anxiety or depression state evaluated by emotional scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of patient's quality of life
Time Frame: Baseline and two weeks postoperative
difference of scores of clinical effect scales
Baseline and two weeks postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of patients's emotional state
Time Frame: Baseline and two weeks postoperative
difference of scores of emotional state scales
Baseline and two weeks postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Study Director: Haiying Liu, doctor, spinal surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

September 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

November 26, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (Actual)

December 7, 2017

Study Record Updates

Last Update Posted (Actual)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 6, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Emotionalstate

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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