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

NCT02967601 | Completed

• 1 other identifier: shiv01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shivering

Keywords

shivering, cesarean section, anxiety, STAI

Outcome Measures

Primary Outcomes (1)

• Correlation between shivering and anxiety (STAI score)

  during elective cesarean section

Secondary Outcomes (3)

• 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

Study Arms (1)

Elective Cesarean Section

Behavioral: STAI (State Trait Anxiety Inventory) questionaire

Interventions

STAI (State Trait Anxiety Inventory) questionaire BEHAVIORAL

Each patient would fill the STAI questionaire before Cesarean Section (on the same day, in the morning)

Elective Cesarean Section

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• conversion to general anesthesia
• any severe obstetric complications, which affects obstetric or anesthesiology procedure
• severe bleeding
• language barrier
• anxiolytic/psychotropic drugs use

Sponsors & Collaborators

• Bartłomiej Wódarski: lead

Study Sites (1)

Samodzielny Publiczny Szpital Kliniczny im. prof. W. Orłowskiego w Warszawie

Warsaw, Masovian Voivodeship, 00-416, Poland

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: December 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)