Protocol summary

Study aim
Determining the Effect of Prevention Program on Hypothermia on Central Temperature and Shivering of Women Under Caesarean section at Ali ibn Abitaleb Hospital, Zahedan, 1396
Design
This study will be done on 92 candidates for undergoing cesarean section undergoing cesarean section attending a study in the operating room of Ali ibn Abi Talib (Zahedan) Hospital in 1396. They were randomly divided into control and intervention groups.
Settings and conduct
46 patients will receive the usual care of the operating room. Then 46 pregnant women will enter the intervention group. The women in the intervention group will be warmed up with a sterilization solution until the temperature reaches 32 ° C. The infusion will be performed at 38 to 40 ° C. And transmitted on the bed after surgery. Central temperature, chills and hemodynamic characteristics of the patient will be measured at 7 times.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: 1-Spinal anesthesia 2. Failure to receive corticosteroid 3. Failure to receive non-steroidal anti-ulcer and magnesium sulfate 4. No underlying illness 5. Termination of pregnancy at the time of term Exit criteria: 1. The occurrence of any condition that affects the normal course of anesthesia and surgery 2. Receiving blood during surgery 3. A significant decrease in blood pressure during surgery 4-prolonged surgical time
Intervention groups
In this quasi-experimental study, 92 women undergoing cesarean section (emergency and elective surgery) that will undergo a surgical operation in the operating room of the Ali ibn Abi Taleb Hospital in Zahedan, will be targeted and will be included in the study. At first, 46 patients with a candidate for cesarean section who have criteria for entering the study will be selected and will enter the control group. In the routine control group, routine patients will receive routine care of the operating room, including dripping, dripping and infusion of fluids at the operating room temperature, and then transferred to the recovery room after surgery, and will be hospitalized in blanket blankets. Central temperature, blood pressure, pulse, and oxygen saturation of arterial blood, seven times, will be measured. Before starting anesthesia, after induction of anesthesia and before surgery, 30 minutes after surgery, after surgery, At the time of recovery, 0.5 hours and 1 hour after the patient's transfer to the recovery. In this group of patients, the necessary information will be entered into the information registration form on the basis of the data collection tool without any special intervention. After completing the sample size of the control group, 46 pregnant women eligible for inclusion criteria for the intervention group will be selected. Before the beginning, the goals and method of work will be explained to the people and written consent will be obtained from them. The intervention group women, after entering the operating room and placed on the surgical bed, are heated with a sterilized solution until the temperature reaches 32 ° C and eventually drips. Injections of injectable fluids will begin with a doctor prescription (warmed up at 38-40 ° C in the blood vessel). Upon completion of surgery, patients will be transferred from the operation bed to the recovery bed (which has been prepared in the recovery plan after the operation). So, half an hour before the patient is transferred to the recovery room, the bed will be prepared in the standard procedure, and two to three spa tubs will be placed in the bed to welcome the patient's bed at the appropriate temperature of the patient. These patients are similar to those in the control group in 7 cycles. Central temperature, blood pressure, pulse and arterial oxygen saturation were measured 30 minutes after anesthesia, after induction of anesthesia and before surgery. From the beginning of the surgery, after the completion of the surgery, it will be monitored at recovery time, 0.5 hours and 1 hour after the patient's transfer.
Main outcome variables
1. The frequency of incidence of hypothermia in women undergoing cesarean section with spinal anesthesia is different in the intervention group and the control group after the implementation of the hypothermic prevention program. 2. The incidence of shivering in women undergoing cesarean section with spinal anesthesia is different in the intervention group and the control group after the implementation of the hypothermic prevention program.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171002036505N1
Registration date: 2017-12-03, 1396/09/12
Registration timing: registered_while_recruiting

Last update: 2017-12-03, 1396/09/12
Update count: 0
Registration date
2017-12-03, 1396/09/12
Registrant information
Name
Zahra Pishkar Mofrad
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2481
Email address
pishkar@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of prevention program on hypothermia on central temperature and chills in women undergoing cesarean section surgery in Ali bin Abitaleb Hospital, Zahedan, 2017
Public title
The effect of warm serum on central body temperature and chills
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Spinal anesthesia No intake of corticosteroid No administration of non-steroidal anti-spasm and magnesium sulfate No underlying disease (thyroid, diabetes, cardiovascular disease and chronic hypertension and preeclampsia) Ending pregnancy at the time of the term (37 to 42 weeks). No fever, addiction, rupture of amniotic sac, polyhydramnios and oligohydroamnios. No constraint for controlling body temperature through tympanic curves.
Exclusion criteria:
Occurrence of any situation where the process Natural anesthetic and surgical treatment of the patient. Receiving blood during surgery. Significant loss of blood pressure during surgery. Blood pressure 20% greater than before anesthesia Prolonged surgical time (more than an hour).
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
No 1 Street of Health Fellowship, Faculty of Nursing Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Approval date
2017-06-22, 1396/04/01
Ethics committee reference number
IR.ZAUMS.REC.1396.59

Health conditions studied

1

Description of health condition studied
Caesarean section
ICD-10 code
O82
ICD-10 code description
Delivery by elective caesarean section; delivery by emergency caesarean section

Primary outcomes

1

Description
Central body temperature
Timepoint
Pre-intervention-during intervention-after intervention
Method of measurement
Based on degrees C and using the tympanic thermometer

2

Description
Chill
Timepoint
During intervention - after intervention
Method of measurement
Based on Crossley classification. Grade 1 = No shivering, Grade 2 = Mild shivering (Hair straightening, Peripheral cyanosis visible without vibration), Grade 3 = Medium shiver (visible muscle tremor in a group of muscles), Grade 4 = Severe chills (Muscle vibration in All muscles of the body)

Secondary outcomes

1

Description
Blood pressure
Timepoint
Before intervention - during intervention - after intervention
Method of measurement
Systolic and diastolic blood pressure using a monitor based on mm of mercury

2

Description
Pulse rate
Timepoint
Before intervention - during intervention - after intervention
Method of measurement
Using the monitor and based on the number in minutes

3

Description
Respiratory rate
Timepoint
Before intervention - during intervention - after intervention
Method of measurement
Using the monitor and based on the number in minutes

4

Description
Arterial blood oxygen saturation
Timepoint
Before intervention - during intervention - after intervention
Method of measurement
Using the monitor and percentage basis

Intervention groups

1

Description
This semi- experimental study was performed on 92 candidates for cesarean section by spinal anesthesia referring to the operating room of Ali ibn Abi Talib (Zahedan) Hospital in 1396. 46 patients will receive the usual care of the operating room. The cent
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Operating room of Ali ibn Abitaleb Hospital in Zahedan
Full name of responsible person
Zahra pishkar Mofrad
Street address
No 1 Street of Health Fellowship, Faculty of Nursing Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
pishkarz@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Normohammad Bakhshani
Street address
Zahedan University of Medical Sciences, Dr. Hesabi Squ.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3329 5796
Fax
+98 54 3344 2481
Email
fatemeh.bamery71@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Bammeri
Position
Senior Inner Surgery / Collaborator
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 1 Street of Health Fellowship, Faculty of Nursing Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3267 4092
Fax
Email
fatemeh.bamery71@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Pishkar Mofrad
Position
Instructor, faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 1 Street of Health Fellowship, Faculty of Nursing Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
Email
pishkarz@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Bammeri
Position
Senior Surgical Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 1 Street of Health Fellowship, Faculty of Nursing Midwifery
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
fatemeh.bamery71@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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