Influence of Preoperative Anxiety on Shivering During Elective Caesarean Section Under Spinal Anaesthesia

Shivering Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967601
• Other study ID #: shiv01
• 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
• 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 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.

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

Related Conditions & MeSH terms

• Shivering

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