The Effect Of Acupuncture Before The Start Of Anesthesia On Hemodynamic Criteria Changes On Preeclamptic Pregnant Women Candidate For Cesarean Section.
The Aim Of This Study Was To Evaluate The Efficacy Of Acupuncture Before The Start Of Anesthesia On Hemodynamic Criteria Changes On Preeclamptic Pregnant Women Undergoing Caesarean Section.
It Is Randomized Clinical Trial And Triple Blinded Study.
The Study Population Is Pregnant Women With Preeclampsia By A Gynecologist Diagnosed And Undergoing Caesarean Section At Valiasr Hospital Of Tehran. Inclusion Criteria Is The Diagnosis Of Preeclampsia.
If Having Any Underlying Disease Or The Presence Of Contraindications For Acupuncture And Patient Unsatisfaction, The Person Will Be Excluded.
The Study Population Is 98 Patients, Including 49 Cases And 49 Controls.
At The Beginning Of Entering The Operating Room Initial Patient's Hemodynamic Will Be Assessed And Then Acupuncture Specialist Will Acupuncture. The Process Of Induction Of Anesthesia And Hemodynamic Changes At Different Times Are Measured And Entered In The Questionnaire.
These Variables Include Systolic And Diastolic Blood Pressure , Arterial Saturation And Heart Rate Per Minute . In The Control Group , The Needles Are Improperly Applied And Then Hemodynamic Changes Compare With The Intervention Group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101924605N1
Registration date:2016-01-13, 1394/10/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-13, 1394/10/23
Registrant information
Name
seyyedeh golnaz sadeghian baboli
Name of organization / entity
tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 2227 8470
Email address
sg-sadeghianb@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Acupuncture Before The Start Of Anesthesia On Hemodynamic Criteria Changes On Preeclamptic Pregnant Women Candidate For Cesarean Section.
Public title
The Effect Of Acupuncture Before The Start Of Anesthesia On Intraoperative Hemodynamic Criteria Changes.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Have Informed Consent For Inclusion؛ Probability Of Beneficial Effects On People; Approval Of Preeclampsia By Obstetricians
Exclusion Criteria: Lack Of Conse؛nt; Coagulopathy; Diabetes;Epilepsy; Cancer; Acute Stroke
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee Of Tehran University Of Medical Sciences
Street address
4th Floor- Block 23 - 16 Azar St -Tehran - Iran
City
Tehran
Postal code
Approval date
2015-09-24, 1394/07/02
Ethics committee reference number
IR.TUMS.REC.1394.828
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O010
ICD-10 code description
Pre-Existing Hypertension Complicating Pregnancy, Childbirth And The Puerperium
Primary outcomes
1
Description
Heart Rate
Timepoint
Before Intervention- After Intervention
Method of measurement
Novin Saadat Machine
2
Description
Blood Pressure
Timepoint
Before Intervention- After Intervention
Method of measurement
Novin Saadat Machine
3
Description
Saturation Of Arterial Pressure
Timepoint
Before Intervention- After Intervention
Method of measurement
Novin Saadat Machine
Secondary outcomes
empty
Intervention groups
1
Description
In This Study, Acupuncture Is Considered By The Acupuncturist Using Acuahealth Device At Predetermined Points And Then The Process Of Intubation And Anesthesia Will Be Done. Both Control And Intervention Group Will Have The Same Type Of Surgery And Anesthesia.
Category
Treatment - Other
2
Description
In The Control Group Acupuncture Using Acuahealth Will Be Done At The Wrong Positions. The Anesthesia And Intubation Will Be Similar To The Intervention Group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Valiasr Hospital
Full name of responsible person
Doctor Negar Eftekhar
Street address
Caesarean Section Room, Tehran Valiasr Hospital, Keshavarz BLVD, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian Scientific Acupuncture Association
Full name of responsible person
Golnaz Sadeghian
Street address
Khorramshahr St.,Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?