Preoperative Anxiety's Incidence and Related Factors in Surgical Patients

Preoperative Anxiety Clinical Trial

Official title:

Preoperative Anxiety's Incidence and Related Factors in Surgical Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03162692
• Other study ID #: XYFY2017-KL021-01
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2017
• Last updated: May 19, 2017
• Start date: April 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: May 2017
• Source: Xuzhou Medical University
• Contact: Jindong Liu, M.S
• Phone: +86-13951355136
• Email: liujindong1818[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Preoperative anxiety is often described as an uncomfortable, tense unpleasant mood before surgery, an emotional response to a potential challenge or threat to reality. Data show that adult patients with preoperative anxiety rate of 30-40%. The main reason for the occurrence of patients for surgery, anesthesia and other factors of fear. Preoperative anxiety itself is not a mental illness, but studies have confirmed that the occurrence of preoperative anxiety and postoperative complications were positively correlated, and the existence of preoperative anxiety in patients with conventional postoperative analgesic effect is poor. At present, there are still few studies on the relationship between preoperative anxiety and postoperative complications and analgesia. At the same time, there is a lack of large sample size to study the incidence of preoperative anxiety and its related predictors.

Description:

Surgical patients often have varying degrees of preoperative anxiety.The aim of this study was to determine the incidence of preoperative anxiety and related predictors, and to evaluate the effect of anxiety on anesthesia and postoperative pain and prognosis. The study also showed that prostaglandin, catecholamines, cortex Effects of alcohol and inflammatory cell level on postoperative pain in patients with preoperative anxiety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 years old

• Sign that informed consent is willing to participate in the study

• Education: primary school and above

• 1 days after elective general anesthesia surgery

• ASA score grade I-III

Exclusion Criteria:

• Emergency surgery

• Severe mental illness patients (such as anxiety, depression, schizophrenia, etc.)

• Taking anti-anxiety or antidepressants (benzodiazepines, tricyclic antidepressants, selective serotonin inhibitors, monoamine oxidase inhibitors, etc.)

Related Conditions & MeSH terms

• Anxiety Disorders
• Elective Surgery
• Intravenous Anesthesia
• Preoperative Anxiety

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	XuZhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (9)

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Maki Y. [A behavioral and neurochemical study on the mechanism of the anxiolytic effect of monoamine oxidase inhibitors]. Hokkaido Igaku Zasshi. 2001 May;76(3):133-42. Review. Japanese. — View Citation

Matsumoto K, Puia G, Dong E, Pinna G. GABA(A) receptor neurotransmission dysfunction in a mouse model of social isolation-induced stress: possible insights into a non-serotonergic mechanism of action of SSRIs in mood and anxiety disorders. Stress. 2007 Ma — View Citation

Micó JA, Prieto R. Elucidating the mechanism of action of pregabalin: a(2)d as a therapeutic target in anxiety. CNS Drugs. 2012 Aug 1;26(8):637-48. doi: 10.2165/11634510-000000000-00000. Review. — View Citation

O'Donovan A, Slavich GM, Epel ES, Neylan TC. Exaggerated neurobiological sensitivity to threat as a mechanism linking anxiety with increased risk for diseases of aging. Neurosci Biobehav Rev. 2013 Jan;37(1):96-108. doi: 10.1016/j.neubiorev.2012.10.013. Ep — View Citation

Yamauchi M, Hiraoka S, Imanishi T. [Role of the serotonergic nervous system in anxiety disorders and the anxiolytic mechanism of selective serotonin reuptake inhibitors]. Nihon Shinkei Seishin Yakurigaku Zasshi. 2006 Nov;26(5-6):193-8. Review. Japanese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood inflammation index	extraction of patients with arterial blood to laboratory tests	Extraction of arterial blood before anesthesia induction
Primary	Anxiety level	as measured by STAI (state-trait anxiety questionnaire)	All patients are evaluated one day before surgery
Secondary	VAS pain score	as measured by visual smileys scale	at 3 hours, 6 hours, 24 hours, 48 hours after surgery