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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02967601
Other study ID # shiv01
Secondary ID
Status Completed
Phase N/A
First received November 16, 2016
Last updated January 6, 2018
Start date December 2016
Est. completion date December 31, 2017

Study information

Verified date January 2018
Source Centre of Postgraduate Medical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background Shivering occurs in circa 50 percent of cases during caesarean section under spinal anesthesia. The phenomenon's 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 KsztaƂcenia 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age > 18 y.o.

- ASA 1-2

- signed informed consent form after reading the information about the study and talking with one of the investigators

Exclusion Criteria:

- conversion to general anesthesia

- any severe obstetric complications, which affects obstetric or anesthesiology procedure

- severe bleeding

- language barrier

- anxiolytic/psychotropic drugs use

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
STAI (State Trait Anxiety Inventory) questionaire
Each patient would fill the STAI questionaire before Cesarean Section (on the same day, in the morning)

Locations

Country Name City State
Poland Samodzielny Publiczny Szpital Kliniczny im. prof. W. Orlowskiego w Warszawie Warsaw Masovian

Sponsors (1)

Lead Sponsor Collaborator
Bartlomiej Wódarski

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between shivering and anxiety (STAI score) during elective cesarean section
Secondary Correlation between shivering and patient's temperature (noninvasive) during elective cesarean section
Secondary Correlation between shivering and patient's subjective assesment of anesthesiology team attitude during elective cesarean section
Secondary Correlation between shivering and patient's obstetric history socio-economical data. during elective cesarean section
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