The Correlations Between Clinical Effect and Emotional State | NCT03364777

Studies
The Correlations Between Clinical Effect and Emotional State

NCT03364777

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Dec 7, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Emotional Disorder

Interventions

emotional state

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Estimated

Primary Completion Date

Sep 30, 2019Estimated

Completion Date

Dec 30, 2019Estimated

First Submitted Date

Nov 26, 2017

First Submission Date that Met QC Criteria

Dec 6, 2017

First Posted Date

Dec 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2017

Last Update Posted Date

Dec 7, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Liu Chenjun, spinal surgery, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lumbar surgery patients		patients undergoing lumbar surgery with or without anxiety or depression emotional state	Other: emotional state

Interventions

Name	Type	Description	Arm Group Labels	Other Names
emotional state	Other	anxiety or depression state evaluated by emotional scale	lumbar surgery patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

spinal tumor;
spinal trauma;
congenital spinal disease;
patients diagnosed psychosis;
patients with incomplete clinical informations.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chenjun Liu, doctor	Contact	13651247795		lcj806361@sina.com

Overall Officials

Name	Affiliation	Role
Haiying Liu, doctor	spinal surgery	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26517435	Background	Floyd H, Sanoufa M, Robinson JS. Anxiety's Impact on Length of Stay Following Lumbar Spinal Surgery. Perm J. 2015 Fall;19(4):58-60. doi: 10.7812/TPP/15-022.
22618787	Background	Falavigna A, Righesso O, Teles AR, Baseggio N, Velho MC, Ruschel LG, Abruzzi F, Silva PG. Depression Subscale of the Hospital Anxiety and Depression Scale applied preoperatively in spinal surgery. Arq Neuropsiquiatr. 2012 May;70(5):352-6. doi: 10.1590/s0004-282x2012000500009.

ID	Term
D006262	Health
D011154	Population Characteristics