NCT03364777

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

1.7 years

First QC Date

November 26, 2017

Last Update Submit

December 6, 2017

Conditions

Keywords

lumbar surgery, emotional state

Outcome Measures

Primary Outcomes (1)

  • changes of patient's quality of life

    difference of scores of clinical effect scales

    Baseline and two weeks postoperative

Secondary Outcomes (1)

  • changes of patients's emotional state

    Baseline and two weeks postoperative

Study Arms (1)

lumbar surgery patients

patients undergoing lumbar surgery with or without anxiety or depression emotional state

Other: emotional state

Interventions

anxiety or depression state evaluated by emotional scale

lumbar surgery patients

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 26517435BACKGROUND
  • 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.

    PMID: 22618787BACKGROUND
  • D'Angelo C, Mirijello A, Ferrulli A, Leggio L, Berardi A, Icolaro N, Miceli A, D'Angelo V, Gasbarrini G, Addolorato G. Role of trait anxiety in persistent radicular pain after surgery for lumbar disc herniation: a 1-year longitudinal study. Neurosurgery. 2010 Aug;67(2):265-71. doi: 10.1227/01.NEU.0000371971.51755.1C.

    PMID: 20644411BACKGROUND

MeSH Terms

Interventions

Mental Health

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Study Officials

  • Haiying Liu, doctor

    spinal surgery

    STUDY DIRECTOR

Central Study Contacts

Chenjun Liu, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
spinal surgery

Study Record Dates

First Submitted

November 26, 2017

First Posted

December 7, 2017

Study Start

January 1, 2018

Primary Completion

September 30, 2019

Study Completion

December 30, 2019

Last Updated

December 7, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share