The Effect of Forced Air Warming During Caseraen Section on Maternal Hypothermia: Randomized Controlled Trial

December 17, 2021 updated by: Cansu Akdag Topal, Hacettepe University

The Effect Of Forced Air Warming Used For Different Body Parts During Caseraen Section On Maternal Hypothermia, Shivering, Thermal Comfort, Apgar Score And Breastfeeding: Randomized Controlled Trial

During the cesarean section; Hypothermia can be seen due to reasons such as anesthesia, premedication drugs, cold operating room environment, exposure of tissues and organs, and use of cold intravenous fluids. Hypothermia associated with cesarean may affect maternal and fetal health negatively. As a result of hypothermia, coagulopathy, infection, undesirable cardiac events that cause an increase in oxygen consumption, delay in postoperative recovery and wound healing, postoperative nausea and vomiting, chills and relief may be observed in the mother. Newborns born from hypothermic mothers have lower body temperature, pH and Apgar scores. It is important to evaluate all women in terms of risk factors in the preoperative period in the prevention of hypothermia and complications related to hypothermia. Prevention of hypothermia, which has negative effects on maternal and newborn health, is one of the risks that the nurse can address independently. Therefore, this research; In order to determine the effect of heating different body areas using compressed air heating technique during cesarean section on hypothermia, tremor, thermal comfort, postpartum comfort and maternal satisfaction, a parallel group was planned as a randomized controlled trial. The study is planned to be conducted in Hacettepe University Adult Hospital Gynecology and Obstetrics Department delivery room and obstetrics service. Research data, Introductory Information Form (Appendix 1), Obstetric and Postpartum Features Form (Appendix 2), Patient Monitoring Form (Appendix 3), Termal Comfort Perception Scale (Appendix 4), Shivering Level Diagnostic Form (Appendix 5), LATCH Breastfeeding The Diagnostic and Measurement Tool (Appendix 6) will be collected using the Visual Analogue Scale (Appendix 7) and the Thermal Comfort Scale that will be developed by the researchers. Pregnant women who meet the inclusion criteria will be included in the research. Women will be divided into 4 groups as the lower extremities are heated, the upper extremities are heated, the whole body is heated, and the control group. According to the group of women; It will be heated 30 minutes before surgery and 30 minutes after surgery with lower limb, upper limb or whole body. Women in the control group will not be heated.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was planned as a parallel group randomized controlled study in order to determine the effect of heating different body parts using forced air warming technique during cesarean section on maternal hypothermia, shivering, thermal comfort, the Apgar score of the newborn and breastfeeding.

In the preparation phase of the research; Determining the rate of hypothermia in women applying to the delivery room of Hacettepe University Adult Hospital for planned cesarean section, determining and procuring the devices to be used in the study, and establishing experimental and control groups will be realized.

Body temperatures of women will be measured for 2 weeks in order to determine the rate of hypothermia in women who have had cesarean section in the institution where the study will be conducted. Body temperature of women will be started 30 minutes before the cesarean section and will be measured every 15 minutes until 30 minutes after the operation. By determining the prevalence of hypothermia after cesarean section in women; It is aimed to reveal the necessity of heating with compressed air heating technique.

  • Women are admitted to the delivery room 60-90 minutes before the cesarean operation. The Introductory Information Form will be applied by the researcher using face-to-face interview before the women are admitted to the operating room.
  • 30 minutes before the operation, women's body temperature, shivering, blood pressure, pulse and respiratory values will be evaluated every 15 minutes and recorded on the Patient Monitoring Form. In addition, the Temperature Comfort Scale, which will be developed by the researchers, will be applied by face to face interview method.

Applications During Cesarean Surgery

  • During the operation, women's body temperature, temperature comfort score, shivering, blood pressure, pulse, respiration and SpO2 values will be evaluated every 15 minutes and recorded on the Patient Monitoring Form.
  • With the birth of the baby; The newborn's body temperature, 1st and 5th minute Apgar score will be evaluated and recorded on the Obstetric and Postpartum Characteristics Form.

Applications to be Made Within 30 Minutes After Cesarean Surgery

  • After the cesarean operation, women will be monitored in the recovery unit for 30 minutes. Body temperature, temperature comfort score, shivering, blood pressure, pulse, respiration and SpO2 values will be evaluated every 15 minutes after the women are admitted to the recovery unit and recorded on the Patient Monitoring Form. In addition, the Temperature Comfort Scale, which will be developed by the researchers, will be applied to women 30 minutes after the operation for the second time.
  • The pain level of women will be evaluated with the Visual Pain Scale 30 minutes after surgery.
  • In the institution where the research will be conducted, all women are given a heated blanket at 70 0C when they feel cold and shiver after cesarean section. The number of covers used varies depending on the demand of the woman. Researcher women will not interrupt this routine care they receive. The number of heated covers used by women will be recorded on the Obstetric and Postpartum Characteristics Form.

Applications to be Performed in Obstetrics and Gynecology Service after Cesarean Operation

  • Information such as the need for analgesia, time to start breastfeeding, first mobilization time, gas, stool and urine output will be obtained from the patient file and recorded in the Obstetric and Postpartum Characteristics Form.
  • The pain level of women will be evaluated repeatedly with the Visual Pain Scale (VAS) at the 24th hour after surgery. Due to the effect of anesthesia and the administration of analgesics upon the request of the doctor within the first day after cesarean operation, the VAS score after 24 hours will be evaluated.
  • Before discharge, the development of postpartum complications in a woman will be evaluated and recorded on the Obstetric and Postpartum Features Form.
  • At Hacettepe University Adult Hospital Gynecology Service, the breastfeeding status of mothers of newborns is evaluated using the LATCH Breastfeeding Diagnostic and Measurement Tool. Effective breastfeeding score assessed by the nurses: LACTH score will be evaluated and recorded on the Obstetric and Postpartum Characteristics Form.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • - between the ages of 18-35
  • Speak, understand and write Turkish
  • 37 weeks and more pregnant
  • ASA I (Normal, a disease other than surgical pathology that does not cause a systemic disorder or a healthy person without a systemic problem)
  • Spinal anesthesia is planned
  • No high-risk pregnancy diagnosis (Oligodydroamniosis, early membrane rupture, gestational diabetes mellitus, preeclampsia, fetal tachycardia, nonreactive NST, intrauterine growth retardation)
  • Body mass index> 19 kg / m2 and <40 kg / m2,
  • Having a single pregnancy and
  • Pregnant women who agreed to participate in the study will be included in the sample.

Exclusion Criteria:

  • - Emergency cesarean section
  • Individuals with Forced Air Warming contraindications (Acute infection, Maternal fever before operation, etc.)
  • In case of any complication that may develop in the mother or newborn at any stage of the research
  • Pregnant women who want to leave the research at any stage of the research will be excluded from the sample.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: lower extremities
the women's lower extremities will be heated with Forced Air Warming
Other: Forced Air Warming
We will use Forced Air Warming for cesarean patient
EXPERIMENTAL: upper extremities
the women's upper extremities will be heated with Forced Air Warming
Other: Forced Air Warming
We will use Forced Air Warming for cesarean patient
EXPERIMENTAL: whole body
the women's whole body will be heated with Forced Air Warming
Other: Forced Air Warming
We will use Forced Air Warming for cesarean patient
NO_INTERVENTION: control group
there is no intervention for this group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Hypothermia
Time Frame: 30 minutes before the intervention to 30 minutes after the intervention.
Maternal hypothermia is defined as body temperature falling below 36 ° C.
30 minutes before the intervention to 30 minutes after the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shivering
Time Frame: 30 minutes before the intervention to 30 minutes after the intervention.
Shivering is a bodily function in response to cold in humans
30 minutes before the intervention to 30 minutes after the intervention.
Thermal Comfort
Time Frame: 30 minutes before the intervention to 30 minutes after the intervention.
Thermal comfort is defined as the condition of mind that expresses satisfaction with the thermal environment.
30 minutes before the intervention to 30 minutes after the intervention.
Apgar Score
Time Frame: 30 minutes before the intervention to 30 minutes after the intervention.
An objective score of the condition of a baby after birth. This score is determined by scoring the heart rate, respiratory effort, muscle tone, skin color, and response to a catheter in the nostril.
30 minutes before the intervention to 30 minutes after the intervention.
Breastfeeding Timing
Time Frame: 30 minutes before the intervention to 30 minutes after the intervention.
The time between the start of breastfeeding of the newborn after birth
30 minutes before the intervention to 30 minutes after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

Cigdem Yucel
Ozgur Ozyuncu

Investigators

  • Study Director: Ozgur Ozyuncu, PhD, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2021

Primary Completion (ACTUAL)

June 30, 2021

Study Completion (ANTICIPATED)

August 31, 2022

Study Registration Dates

First Submitted

March 12, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (ACTUAL)

December 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 17, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-180051

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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