Somatic Symptom Disorders in Patients With Myocardial Bridge

Somatic Symptom Disorder Clinical Trial

Official title:

EARLY Assessment of Somatic Symptom Disorder in Patients With MYOcardial Bridge by Somatic Symptom Scale China (SSS-CN) (EARLY-MYO-SSS-CN-Ⅱ)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664387
• Other study ID #: SSSCN202010
• Status: Completed
• Start date: October 30, 2016
• Est. completion date: May 8, 2020

Study information

• Verified date: October 2020
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study was to investigate the prevalence of physical and mental disorder in the population of patients with myocardial bridge and to describe the relationship between clinical features and the occurrence of somatic disorder.

Description:

Myocardial bridge (MB), a congenital cardiac anomaly, is an unignored contribution to chest pain. Patients with MB often complain about chest discomfort more serious than the degree of vessel compression. The symptoms are also often inconsistence with the degree of coronary stenosis. Reports suggested that patients with MB may companioned with depression and anxiety. Moreover, patients with MB often have other systemic complaints including stomach pain, pain on the back, ear blockage, et al. Investigators assume that somatic symptom disorder (SSD) may play a part in aggregating the severity of symptoms. In order to screen SSD, investigators previously developed the Somatic Symptom Scale-China (SSS-CN) questionnaire. It is a somatic and psychological symptom scale which was developed based on the DSM-5 to assess a combination of psychological, behavioral and somatic symptoms. It is designed to assess the presence and severity of the symptoms. Investigators have validated its reliability and validity in a previous study. The purpose of this study was to investigate the prevalence of physical and mental disorder in the population of patients with MB and to describe the relationship between clinical features and the occurrence of somatic disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1357
• Est. completion date: May 8, 2020
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• cardiology inpatients with the age older than 18, complained with chest discomfort and was suspected with coronary artery disease.

• undertook Somatic Symptom Scale-China (SSS-CN) questionnaire, Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) questionnaires.

• underwent cardiac angiography.

• agree to participate.

Exclusion Criteria:

• patients who are in emergency or unconsciousness.

• patients who refuse to participate or with unfinished questionnaire.

• the questionnaires were undertook after the angiography.

• patients who have previously been confirmed to have mental disorders, mental retardation or dementia, cannot finish questionnaires

• patients who currently take anti-anxiety or anti-depression agents.

• patients who have been confirmed to have heart diseases other than coronary vascular disease.

• patients who have been previously confirmed to have other physical diseases.

Related Conditions & MeSH terms

• Disease
• Medically Unexplained Symptoms
• Myocardial Bridge
• Myocardial Bridging
• Somatic Symptom Disorder

Intervention

Diagnostic Test:
• coronary angiography
A coronary angiography is a test to find out if there is stenosis in coronary artery.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the score of Somatic Symptom Scale-China (SSS-CN)	to compare the score of Somatic Symptom Scale-China questionnaire between patients with and without myocardial bridge. SSS-CN is a self-administered questionnaire with 20 items and scoring 1, 2, 3, 4 to each item. The total score is from 20 to 80. The higher the score is, the higher frequency that the symptoms presented.	within 24 hours before the coronary angiography.