The Effect of ginger on prevention of headache and shivering after spinal anesthesia in patients with cesarean section referred to Kamali hospital in Karaj, 2016
Determine the effect of ginger on prevention of headache and shivering after spinal anesthesia in cesarean section
Design
This is a clinical trial study, randomized, open blindness, based on a specific group, Intervention with parallel groups, and trial phase 2, carried out with 170 sample size.
Settings and conduct
This study was carried out as a parallel clinical trial without blinding in Kamali hospital in Karaj. Sampling was done using simple random allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 20 to 40 years 2.term pregnancy (42-37 weeks) and single Pregnant women who candidate for elective cesarean section; ASA class 1,2 .3 - Receiving written consent from patients. 4. No history of psychiatric problems. 5. Absence of hypothyroidism. 6. Failure to have meningitis at the time of study. 7. the lack of migraine. 8. the lack of record seizure or headache. 9. Start a headache within 72 hours. First cesarean section after spinal anesthesia. 10- the lack of Pre-eclampsia or eclampsia.
Exclusion criteria: 1-unwillingness for participating in the study at each stage 2- cesarean section that lasts more than an hour 3- Fevered patients or unstable vital signs 4.history of psychotropic or opium drugs consumption 5. alcohol or drug abuse 6. Drug sensitivity
Intervention groups
Intervention group: Ginger 8 hours before spinal anesthesia and 8 hours after that, TDS (three times daily) until shivering.
Control group: did not use pre-medication ginger, and only headache treatment with novafen and treatment of chills with meperidine
Main outcome variables
Post anesthesia shivering(PAS), Post dural puncture headache(PDPH)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180110038302N1
Registration date:2018-04-29, 1397/02/09
Registration timing:retrospective
Last update:2018-04-29, 1397/02/09
Update count:0
Registration date
2018-04-29, 1397/02/09
Registrant information
Name
Mansoureh Yazdkhasti
Name of organization / entity
Alborz University medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 8856
Email address
m.yazdkhasti@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-21, 1396/02/31
Expected recruitment end date
2018-03-22, 1397/01/02
Actual recruitment start date
2017-06-21, 1396/03/31
Actual recruitment end date
2018-04-20, 1397/01/31
Trial completion date
empty
Scientific title
The Effect of ginger on prevention of headache and shivering after spinal anesthesia in patients with cesarean section referred to Kamali hospital in Karaj, 2016
Public title
The effect of ginger on headache and shivering after spinal anesthesia in patients with cesarean section
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria:1- Age of 20 to 40 years 2. pregnancy (37-42 weeks) and single Pregnant women who candidate for elective cesarean section; ASA class 1,2 .3 - Receiving written consent from patients. 4. No history of psychiatric problems. 5. Absence of hypothyroidism. 6. No meningitis at the time of study. 7. No migraine. 8. No seizure or headache. 9. Start a headache within first 72 hours after spinal anesthesia. 10- No Pre-eclampsia or eclampsia.
Exclusion criteria:
Exclusion criteria: 1-unwillingness for participating in the study at each stage 2- cesarean section that lasts more than an hour 3- Fevered patients or unstable vital signs 4.history of psychotropic or opium drugs consumption 5. alcohol or drug abuse 6. Drug sensitivity
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
170
Actual sample size reached:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Firstly, a list of women from Cesarean section was prepared weekly. Then they were contacted with each one and the purpose and method of the study were explained. A written consent was obtained from women eligible to enter the study and each person was given an ID. Then, a simple random allocation was performed based on table of random numbers. Beginning, direction of numbers were determinate from top to bottom of table of random numbers. Based on the direction of the top-down table, the even numbers were selected for the intervention group and the odd numbers for the control group. These numbers were recorded on a sheet and allocated to the intervention and control groups. This process were continued until the sample size (170) was completed. Thus, two groups, each with 85 participants were formed.
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
Alborz University of Medical Science
Street address
No.1, Eshteraki Blvd, Baghestan street, school of nursing And midwifery, karaj, Iran
City
karaj
Province
Alborz
Postal code
561-31452
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
ABZUMS.REC 1396.7
Health conditions studied
1
Description of health condition studied
Post Anesthesia Shivering(PAS), Post dural puncture headache(PDPH)
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Complications of spinal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Headache Intensity
Timepoint
From 24 hours before cesarean section every 8 hours and continue after cesarean section until headache
Method of measurement
Visual analog scale(VAS) ( 0 -10) was used to measure the severity of headache.
Secondary outcomes
1
Description
Shivering intensity
Timepoint
1, 3, 12 and 72 hours after cesarean
Method of measurement
Crossover-Mahajan criterion for measuring shivering (from 0 to 4)
Intervention groups
1
Description
"In the intervention group" 24 hours before cesarean section, ginger capsule was prescribed 250 mg every 8 hours. After cesarean section, prescriptions for capsules continued before headache. In the event of headache, intervention was discontinued and routine headache treatment was used.
Category
Prevention
2
Description
"Control group": No intervention in control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Dr. Mansoureh Yazdkhshti
Street address
Karaj-Baghestan- Southern Common Blvd.-Alborz Nursing-Midwifery Faculty
City
Karj
Province
Alborz
Postal code
1829346253
Phone
+98 26 3430 4499
Email
Mansoyazd@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mansoureh Yazdkhshti
Street address
Karaj-Baghestan- Southern Common Blvd.-Alborz Nursing-Midwifery Faculty
City
Karj
Province
Alborz
Postal code
1829346253
Phone
+98 26 3430 4499
Email
Mansoyazd@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Mansoureh Yazdkhshti
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Karaj-Baghestan- Southern Common Blvd.-Alborz Nursing-Midwifery Faculty
City
karj
Province
Alborz
Postal code
1829346253
Phone
+98 26 3430 4499
Email
Mansoyazd@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Banafsheh Mushak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Karaj - Shahid Beheshti Avenue - Kamali Hospital Street
City
karj
Province
Alborz
Postal code
1829346253
Phone
+98 26 3222 2021
Email
mashakbanafsheh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mansoureh Yazdkhshti
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Karaj-Baghestan- Southern Common Blvd.-Alborz Nursing-Midwifery Faculty
City
karj
Province
Alborz
Postal code
1829346253
Phone
+98 26 3430 4499
Email
Mansoyazd@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD