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Completed

NCT Number: NCT02967601

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Warsaw, Masovian Voivodeship, 00-416, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STAI (State Trait Anxiety Inventory) questionaire

Behavioral

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

Primary outcomes

  1. Correlation between shivering and anxiety (STAI score)

    Time frame: during elective cesarean section

Secondary outcomes

  1. Correlation between shivering and patient's temperature (noninvasive)

    Time frame: during elective cesarean section

  2. Correlation between shivering and patient's subjective assesment of anesthesiology team attitude

    Time frame: during elective cesarean section

  3. Correlation between shivering and patient's obstetric history socio-economical data.

    Time frame: during elective cesarean section

Sponsors and collaborators

Lead sponsor

Bartłomiej Wódarski

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 18, 2016
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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