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

Sponsor

Hacettepe University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04667000

Collaborator

Cigdem Yucel (Other), Ozgur Ozyuncu (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section Complications Hypothermia	Other: Forced Air Warming	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

parallel group randomized controlled studyparallel group randomized controlled study

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Maternal Hypothermia [30 minutes before the intervention to 30 minutes after the intervention.]
Maternal hypothermia is defined as body temperature falling below 36 ° C.

Secondary Outcome Measures

Shivering [30 minutes before the intervention to 30 minutes after the intervention.]
Shivering is a bodily function in response to cold in humans
Thermal Comfort [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.
Apgar Score [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.
Breastfeeding Timing [30 minutes before the intervention to 30 minutes after the intervention.]
The time between the start of breastfeeding of the newborn after birth

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University	Ankara		Turkey	06100

Sponsors and Collaborators

Hacettepe University
Cigdem Yucel
Ozgur Ozyuncu

Investigators

Study Director: Ozgur Ozyuncu, PhD, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Cansu Akdag Topal, Research Asistant, Hacettepe University

ClinicalTrials.gov Identifier:

NCT04667000

Other Study ID Numbers:

KA-180051

First Posted:

Dec 14, 2020

Last Update Posted:

Dec 20, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cansu Akdag Topal, Research Asistant, Hacettepe University

hypothermia

nursing care

cesarean section

Additional relevant MeSH terms:

Hypothermia

Study Results

No Results Posted as of Dec 20, 2021