The effect of acupressure on hypotension after spinal anesthesia in cesarean section
Design
The clinical trial included a control group, and probability sampling and participant allocated randomly table.
Settings and conduct
This clinical trial study was performed on 64 mothers referred to Imam Reza Hospital. In the intervention group at least 15-20 minutes before spinal anesthesia the pressure is performed at Baihui DU-20, Hegu, ST36 and Neiguan pressure points three times for about 30-60 seconds. The intervention is not performed in the control group. Mother's blood pressure and heart rate will be monitored and recorded every 3 minutes until the end of the operation after assurance of sufficient block level and start of the operation.
Participants/Inclusion and exclusion criteria
single pregnancy, gestational age 38-40 weeks based on first-trimester ultrasound, Systolic blood pressure 100-140mmHg, elective Cesarean section, no medical or midwifery sickness in the current pregnancy such as gestational diabetes & preeclampsia
Intervention groups
In the intervention group, at least 15-20 minutes before spinal anesthesia the pressure is performed at Baihui DU-20, Hegu, ST36 and Neiguan pressure points three times about for 30-60 seconds.
Main outcome variables
blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200312046752N1
Registration date:2020-04-23, 1399/02/04
Registration timing:retrospective
Last update:2020-04-23, 1399/02/04
Update count:0
Registration date
2020-04-23, 1399/02/04
Registrant information
Name
Marzieh Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3323 0425
Email address
ghasemi.m93@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-25, 1398/04/04
Expected recruitment end date
2020-04-23, 1399/02/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on hypotension after spinal anesthesia in cesarean section
Public title
The effect of acupressure on hypotension after anesthesia in cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The gestational age is 38-40 weeks (based on first trimester ultrasound)
Systolic blood pressure is 100-140 mmHg
Single pregnancy
Elective Cesarean section
Exclusion criteria:
Gestational diabetes
Preeclampsia
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah Ave, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-02-18, 1397/11/29
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.023
Health conditions studied
1
Description of health condition studied
Hypotension
ICD-10 code
I95.9
ICD-10 code description
Idiopathic hypotension
Primary outcomes
1
Description
Hypotension
Timepoint
The beginning of spinal anesthesia until the end of cesarean section every 3 minutes
Method of measurement
Mercury barometer
Secondary outcomes
empty
Intervention groups
1
Description
This two-group randomized clinical trial will be carried out on 64 pregnant women admitted for elective cesarean section with spinal anesthesia at Imam Reza Hospital after the approval of the Ethics Committee of the University of Medical Sciences in Mashhad, Iran. After clarifying the purposes of the study and obtaining written consent from the individuals, sampling will be performed by the consideration of the ethical codes.Non-probability sampling will be using based on convenient sampling and inclusion / exclusion criteria. Then the selected participants will be allocated randomly to two groups of acupressure and control using a random number table.Inclusion criteria: single pregnancy, gestational age 38-40 weeks based on first-trimester ultrasound, Systolic blood pressure 100-140mmHg, elective cesarean section, no medical or midwifery sickness in the current pregnancy such as gestational diabetes & preeclampsia. All intraoperative problems will be excluded such as bleeding more than 1.5 liters, prolonged operation time to more than one hour. Mothers’ primary blood pressure and heart rate will be measured and recorded after entering the operating room and before starting the intervention..Then, at least 15-20 minutes before spinal anesthesia the pressure will be performed by the researcher at the pressure points three times for about 30-60 seconds. These pressure points are as follows:Baihui DU-20(At the head and with cun5 distance from the hair growth line), Hegu(On the back of the hand between the 1st and 2nd metacarpal bones and on the radial side of the second metacarp), ST36(3cun below knee joint) and Neiguan(4-5 cm above the first transverse wrist crease, located in the path between the median nerve and between the palms and the bending of the lower arm) .Mother's blood pressure and heart rate will be monitored and recorded every 3 minutes until the end of the operation after assurance of sufficient block level and start of the operation.
Category
Prevention
2
Description
Control group: The control group will be receive routine care. Mother's blood pressure and heart rate will be monitored and recorded every 3 minutes until the end of the operation after assurance of sufficient block level and start of the operation
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Abedian Zahra
Street address
Imam Reza Square, Imam Reza Educational and Research Center, Mashhad
City
Mashhsd
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
abedianz@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tafaghodi Mohsen
Street address
Daneshgah Ave, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Esfahan University of Medical Sciences
Full name of responsible person
Marzieh Ghasemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
5, Shohada Ave, Goujan, farsan town
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8861177891
Phone
+98 38 3323 0425
Fax
Email
ghasemi.m93@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marzieh Ghasemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
5, Shohada Ave, Goujan, farsan town
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8861177891
Phone
+98 38 3323 0425
Fax
Email
ghasemi.m93@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marzieh Ghasemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
5, Shohada Ave, Goujan, farsan town
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8861177891
Phone
+98 38 3323 0425
Fax
Email
ghasemi.m93@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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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