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

NCT ID: NCT02967601

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-12-31

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Elective Cesarean Section

STAI (State Trait Anxiety Inventory) questionaire

Intervention Type: BEHAVIORAL

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

Interventions

STAI (State Trait Anxiety Inventory) questionaire

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bartłomiej Wódarski

OTHER

Sponsor Role: lead

Responsible Party

Bartłomiej Wódarski

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Warsaw, Masovian Voivodeship, Poland

Countries

Poland

Other Identifiers

shiv01

Identifier Type: -

Identifier Source: org_study_id