ShiveringNCT02967601
Influence of Preoperative Anxiety on Shivering During Elective Caesarean Section Under Spinal Anaesthesia
An observational study of Shivering, run by Bartłomiej Wódarski at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shivering
- What is being tested?
- STAI (State Trait Anxiety Inventory) questionaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2016to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women undergoing an Elective Ceasearean Section, qualified for spinal anaesthesia with American Society of Anesthesiologists (ASA) physical status classification system I-II.
Who may be able to join
- 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
Who cannot join
- conversion to general anesthesia
- any severe obstetric complications, which affects obstetric or anesthesiology procedure
- severe bleeding
- language barrier
- anxiolytic/psychotropic drugs use
Trial locations and contacts
1 site in 1 country.
Poland1 site
Samodzielny Publiczny Szpital Kliniczny im. prof. W. Orłowskiego w Warszawie
Warsaw, Masovian Voivodeship, 00-416
About this study
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.
Read more
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
- Being tested
- STAI (State Trait Anxiety Inventory) questionaire
- Keywords
- shivering, cesarean section, anxiety, STAI
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAI (State Trait Anxiety Inventory) questionaireBehavioural
Each patient would fill the STAI questionaire before Cesarean Section (on the same day, in the morning)
| Study group | Role | What they receive |
|---|---|---|
| Elective Cesarean Section | Not described Receives: Behavioral: STAI (State Trait Anxiety Inventory) questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between shivering and anxiety (STAI score)
Measured: during elective cesarean section
Secondary outcomes (3)
Correlation between shivering and patient's temperature (noninvasive)
Measured: during elective cesarean section
Correlation between shivering and patient's subjective assesment of anesthesiology team attitude
Measured: during elective cesarean section
Correlation between shivering and patient's obstetric history socio-economical data.
Measured: during elective cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startDec 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShiveringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartłomiej Wódarski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bartłomiej Wódarski, Centre of Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967601
- Sponsor's protocol ID
- shiv01
- Status last verified
- Jan 2018
- First submitted
- 16 Nov 2016
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Preoperative Anxiety on Shivering During Elective Caesarean Section Under Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT02967601
- Acronym / sponsor ID
- shiv01
- Conditions
- Shivering
- Keywords
- shivering, cesarean section, anxiety, STAI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bartłomiej WódarskiUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Cesarean Section | – | Behavioral: STAI (State Trait Anxiety Inventory) questionaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing an Elective Ceasearean Section, qualified for spinal anaesthesia with American Society of Anesthesiologists (ASA) physical status classification system I-II.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- conversion to general anesthesia
- any severe obstetric complications, which affects obstetric or anesthesiology procedure
- severe bleeding
- language barrier
- anxiolytic/psychotropic drugs use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAI (State Trait Anxiety Inventory) questionaireEach patient would fill the STAI questionaire before Cesarean Section (on the same day, in the morning) | Behavioural | Elective Cesarean Section |
Primary outcome
Correlation between shivering and anxiety (STAI score)
Time frame: during elective cesarean section
3 secondary outcomes
Correlation between shivering and patient's temperature (noninvasive)
Time frame: during elective cesarean section
Correlation between shivering and patient's subjective assesment of anesthesiology team attitude
Time frame: during elective cesarean section
Correlation between shivering and patient's obstetric history socio-economical data.
Time frame: during elective cesarean section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shivering, run by Bartłomiej Wódarski at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between shivering and anxiety (STAI score) (time frame: during elective cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.