Ignite Creation Date:
2024-05-06 @ 9:21 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02967601
Status:
COMPLETED
Last Update Posted:
2018-01-09
First Post:
2016-11-16
Brief Title:
Influence of Preoperative Anxiety on Shivering During Elective Caesarean Section Under Spinal Anaesthesia
Sponsor:
Bartłomiej Wódarski
Organization:
Centre of Postgraduate Medical Education
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
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:
None
Brief Summary:
Background Shivering occurs in circa 50 percent of cases during caesarean section under spinal anesthesia The phenomenons reasons and its mechanism are unclear and while it does not endanger the patients health the sensations proved to be unpleasant and a subject of a number of patients complains
Objectives The main objective of the study is to establish the anxiety factors that influence the risk of muscle-shivering and a detailed assessment of the probability of existence of the link between increased anxiety levels with the shivering in case of patients undergoing the elective caesarean section
Moreover the outcomes of the study could help to further understand the phenomenon reduce its occurence and as a result of that - improve the comfort of the patients in the perioperative period as well as reduce the frequency of pharmacological treatment to halt the symptoms of muscle shivering
Methodology Patients would be asked to fill the STAI State - Trait Anxiety Inventory questionaire in the morning preceding the surgery Results would be interpreted by one of the investigators who obtained a masters degree in psychology Caesarean section under spinal anesthesia would be performed according to standard procedures used in the Samodzielny Publiczny Szpital Kliniczny Centrum Medyczne Kształcenia Podyplomowego SPSK CMKP hospital with standard non-invasive monitoring HR noninvasive blood pressure NIBP oxygen saturation SpO2 Temperature Additionally the anesthesiologist would note the incidence of shivering and its precise timing 1 since the spinal block 2 since the child-birth Moreover patients would rate anesthesiology team influence on her anxiety level during the cesarean section in 5 grade scale - data would be collected by psychologist
The survey is planned for a one year timespan or until 200 patients have enrolled
Objectives The main objective of the study is to establish the anxiety factors that influence the risk of muscle-shivering and a detailed assessment of the probability of existence of the link between increased anxiety levels with the shivering in case of patients undergoing the elective caesarean section
Moreover the outcomes of the study could help to further understand the phenomenon reduce its occurence and as a result of that - improve the comfort of the patients in the perioperative period as well as reduce the frequency of pharmacological treatment to halt the symptoms of muscle shivering
Methodology Patients would be asked to fill the STAI State - Trait Anxiety Inventory questionaire in the morning preceding the surgery Results would be interpreted by one of the investigators who obtained a masters degree in psychology Caesarean section under spinal anesthesia would be performed according to standard procedures used in the Samodzielny Publiczny Szpital Kliniczny Centrum Medyczne Kształcenia Podyplomowego SPSK CMKP hospital with standard non-invasive monitoring HR noninvasive blood pressure NIBP oxygen saturation SpO2 Temperature Additionally the anesthesiologist would note the incidence of shivering and its precise timing 1 since the spinal block 2 since the child-birth Moreover patients would rate anesthesiology team influence on her anxiety level during the cesarean section in 5 grade scale - data would be collected by psychologist
The survey is planned for a one year timespan or until 200 patients have enrolled
Detailed Description:
None
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