The Correlations Between Clinical Effect and Emotional State

Emotional Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03364777
• Other study ID #: Emotionalstate
• Status: Not yet recruiting
• Phase: N/A
• First received: November 26, 2017
• Last updated: December 6, 2017
• Start date: January 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: December 2017
• Source: Peking University People's Hospital
• Contact: Chenjun Liu, doctor
• Phone: 13651247795
• Email: lcj806361[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Disorder

Intervention

Other:
• emotional state
anxiety or depression state evaluated by emotional scale

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of patient's quality of life	difference of scores of clinical effect scales	Baseline and two weeks postoperative
Secondary	changes of patients's emotional state	difference of scores of emotional state scales	Baseline and two weeks postoperative