Ignite Creation Date:
2024-05-06 @ 8:44 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02804009
Status:
UNKNOWN
Last Update Posted:
2016-08-09
First Post:
2016-06-09
Brief Title:
Elective Coronary Angiography and Anxiety Study
Sponsor:
General and Teaching Hospital Celje
Organization:
General and Teaching Hospital Celje
Study Overview
Official Title:
Evaluating and Predicting Anxiety in Patients Undergoing Elective Coronary Angiography
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANGST
Brief Summary:
Anxiety will be assessed from two aspects the somatic and emotional ANGST aims to determine how anxiety correlates with psychological parameters personality traits coping strategies and depressive symptoms and with the outcome of elective coronary angiography CA
Detailed Description:
This research is a prospective cross-section study of patients undergoing elective CA Research design will allow studying anxiety at four timepoints and its correlation with CA outcome and psychological parameters This study will be conducted at the Coronary care unit of the department of Cardiology General and Teaching Hospital Celje Slovenia
Data regarding prior to CA during hospital stay and after discharge variables will be collected in order to control for confounding variables when testing the association between anxiety and psychological parameters All the data needed for this study will be collected within one month from the patient enrollment in this study at four occasions 1 14 days prior CA - all patients will receive questionnaires by post 2 on the day of the admission 2-4 hours before CA 3 24 hours after CA but prior to discharge and 4 4-6 weeks after discharge Clinical and demographical data will be collected from medical records Data regarding anxiety and other psychological parameters will be assessed using standardized questionnaires These will be sent to the patient together with covering letter providing instructions to complete the questionnaires 14 days prior CA without help of family membersfriends A month after CA the questionnaires for anxiety and depressive symptoms will be sent to participants address with reply paid envelope provided
The Republic of Slovenia National Medical Ethics Committee has approved this study
Data regarding prior to CA during hospital stay and after discharge variables will be collected in order to control for confounding variables when testing the association between anxiety and psychological parameters All the data needed for this study will be collected within one month from the patient enrollment in this study at four occasions 1 14 days prior CA - all patients will receive questionnaires by post 2 on the day of the admission 2-4 hours before CA 3 24 hours after CA but prior to discharge and 4 4-6 weeks after discharge Clinical and demographical data will be collected from medical records Data regarding anxiety and other psychological parameters will be assessed using standardized questionnaires These will be sent to the patient together with covering letter providing instructions to complete the questionnaires 14 days prior CA without help of family membersfriends A month after CA the questionnaires for anxiety and depressive symptoms will be sent to participants address with reply paid envelope provided
The Republic of Slovenia National Medical Ethics Committee has approved this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None