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

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.

Study Overview

• Status: Completed
• Conditions: Shivering
• Intervention / Treatment: Behavioral: STAI (State Trait Anxiety Inventory) questionaire

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Poland
  • Masovian
    • Warsaw, Masovian, Poland, 00-416
      • Samodzielny Publiczny Szpital Kliniczny im. prof. W. Orłowskiego w Warszawie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women undergoing an Elective Ceasearean Section, qualified for spinal anaesthesia with American Society of Anesthesiologists (ASA) physical status classification system I-II.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elective Cesarean Section	Behavioral: STAI (State Trait Anxiety Inventory) questionaire; Each patient would fill the STAI questionaire before Cesarean Section (on the same day, in the morning)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between shivering and anxiety (STAI score)	during elective cesarean section

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between shivering and patient's temperature (noninvasive)	during elective cesarean section
Correlation between shivering and patient's subjective assesment of anesthesiology team attitude	during elective cesarean section
Correlation between shivering and patient's obstetric history socio-economical data.	during elective cesarean section

Collaborators and Investigators

• Sponsor: Bartłomiej Wódarski

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 18, 2016

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 6, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: shivering, cesarean section, anxiety, STAI
• Other Study ID Numbers: shiv01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No