In this research the aim is evaluation of chamomile oil on decrease of post dural puncture headache.148 women in the age range of 19 to 40 without history of migraine or psychiatric problems and negative history of hypersensitivity to chamomile that are going under cesarean section surgery with spinal anesthesia will be divided by their informed consent randomly by blocked randomization method to 2 groups the intervention group and control(placebo) group and will be evaluated in a double blind survey.in the intervention group we use chamomile oil ointment on the forehead of participant 20 minutes before and 2 and 4 hours after spinal anesthesia and in the control group we use placebo that is like the main drug in shape,color and smell but without chamomile oil 20 minutes before and 2 and 4 hours after spinal anesthesia and then we compare the occurrence and severity of headache in this 2 group
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060611341N5
Registration date:2017-08-23, 1396/06/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-23, 1396/06/01
Registrant information
Name
Mohammad Hashem Hashempur
Name of organization / entity
Fasa University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 8476
Email address
hashempurm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Fasa University of Medical Sciences
Expected recruitment start date
2017-08-12, 1396/05/21
Expected recruitment end date
2017-09-29, 1396/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation prophylactic effect of chamomile oil on headache after spinal anesthesia for elective cesarean section
Public title
effect of chamomile oil on decrease of headache due to spinal anesthesia in pregnant females
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: pregnant females between 19-40 years that are going under elective cesarean section surgery; informed consent of participants; negative history of migraine or headaches that lasted for more than 2 weeks; negative history of hypersensitivity to chamomile; people who have used analgesics in last 24 hours are not included in the survey; according to American anesthesiologists association standards people physical conditions should be in class 1 or 2; negative contraindication to intrathecal injection of anesthetic agent; negative history of psychiatric diseases
exclusion criteria: The patients who face drop of blood pressure (25% of base systolic blood pressure) while surgery and have to take vasoconstrictors are excluded from survey
Age
From 19 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Ebn-e-sina square
City
Fasa
Postal code
Approval date
2017-07-25, 1396/05/03
Ethics committee reference number
IR.FUMS.REC.1396.214
Health conditions studied
1
Description of health condition studied
headache after dura mater puncture
ICD-10 code
O29.4
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during pregnancy
Primary outcomes
1
Description
occurence rate of headache due to dura mater puncture and its severity
Timepoint
0 ,6 ,12 and 24 hours after surgery
Method of measurement
visual analoge scale vas ruler
Secondary outcomes
1
Description
occurence rate of probable side effects
Timepoint
0,6,12 and 24 hours after surgery and use of chamomilla oil
Method of measurement
occurrence of probable side effects
2
Description
nausea and vomiting
Timepoint
0,6,12 and 24 hours after surgery and use of chamomilla oil
Method of measurement
occurrence of nausea and vomiting
Intervention groups
1
Description
in intervention group participants use chamomile oil ointment on their forehead 20 minutes before and 2 and 4 hours after lumbar puncture
Category
Treatment - Drugs
2
Description
in control group participants use placebo 20 minutes before and 2 and 4 hours after lumbar puncture on their forhead
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fasa Valiasr hospital
Full name of responsible person
Alireza Mohebbinejad
Street address
City
Fasa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa university of medical sciences
Full name of responsible person
Dr Mojtaba Farjam
Street address
Ebn-e-Sina square Fasa University of Medical Sciences
City
Fasa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Alireza Mohebbinejad
Position
medicine student
Other areas of specialty/work
Street address
Fasa University of Medical Sciences
City
Fasa
Postal code
Phone
+98 71 5335 0994
Fax
Email
mohebbi71@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempur
Position
Assistant Professor of traditional Iranian medicine
Other areas of specialty/work
Street address
Fasa University of Medical Sciences
City
Fasa
Postal code
Phone
+98 71 5335 0994
Fax
Email
hashempur@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Alireza Mohebbinejad
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
mohebbi71@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)