The effect of acupressure(UB32) on pain severity of intramuscular magnesium sulfate injection(Z technique)in postpartum cesarean section women with severe Precambrian and eclampsia
The purpose of this study is to determin the effect of acupressure on pain reduction of intramuscular magnesium sulfate injection with Z technique in postpartum cesarean section women .This study will be conducting in Hafez, Zeinabie and Shooshtari hospitals affiliated to Shiraz University of Medical Sciences. 47 eligible post partum cessarian section women affected with sever preeclampsia and eclampsia will enter the study after obtaining a written informed consent. Magnesium sulfate injections are repeated every 4 hours until 24 hours after delivery.In each injection 5cc of drug will be injected in one buttock and the remaining 5cc will be injectde in the other buttock. In this study researcher herself do all the injections. The first injection is without acupressure. The second injection is with acupressure in sham control point which is similar in all patients.
The third one is with pressure on UB32 point. Acupressure point is pressed by thumb directly and continuously with pressure equal to 4.5kg/cm2 for one minute followed by three times sequentially. In second injection the same pressure and methode is used in the sham control point.After each injection patients pain will be measured and documented by co-researcher and according to VAS scale.In order to avoid bias neither patients nor co-researcher know which injection is in real point and which is in sham control point. Finally the severity of pain will be compared in three injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410278505N12
Registration date:2017-01-18, 1395/10/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-18, 1395/10/29
Registrant information
Name
Seyed Saeed Najafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1727 7445
Email address
najafisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2016-12-20, 1395/09/30
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure(UB32) on pain severity of intramuscular magnesium sulfate injection(Z technique)in postpartum cesarean section women with severe Precambrian and eclampsia
Public title
The effect of acupressure on intramuscular injection pain severity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Range of age between 15-45;Willingness to participate;Gynecologist order for magnesium sulfate injection;No chronic pain in lambosacral area including disk herniation
Exclusion criteria:Unwillingness to participate ; Any psychological disease including depression ;Allergy to magnesium sulfate; Receiving pain killers befor injection(Except diclofenac suppository);Femur and hip fracture in the last year
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
47
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
In current study the first intervention is simple,the second is acupressure in sham control point and the third one is acupressure in UB32 point.Patients are not aware of which pressure is in real and which is in unreal point.Co-researcher also does not aware of patients injection group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Research Ethics Committee of Shiraz University of Medical sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
713451978
Approval date
2016-10-09, 1395/07/18
Ethics committee reference number
IR.SUMS.REC.1395.122
Health conditions studied
1
Description of health condition studied
eclampsia and severe preeclampsia
ICD-10 code
XV,010-016
ICD-10 code description
oedema,proteinurea and hypertensive disorder in pregnancy
Primary outcomes
1
Description
Pain
Timepoint
immediately after injection
Method of measurement
Visual analoge scale
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention is intramuscular magnesium sulfate injection with Z technique as a conventional method.5cc of drug will be injected in one buttock and the remaining 5cc will be injected to the other buttock.Then patients will be asked about their pain by co-researcher and according to VAS scale.
Category
N/A
2
Description
The second intervention is intramuscular magnesium sulfate injection with Z technique with acupressure in sham control point which is same in all patients and located in 5cm of posterior superior illiac spine.Acupressure piont is pressed by thumb directly and continuosly with pressure equal to 4.5kg/cm2 for one minute followed by three times sequentially.Then 5cc of drug will be injected in that buttock.Then patients will be asked to lie in the other side and acupressure will be done with same pressure and technique in the other side.Then remaining 5cc will be injected in other buttock immediately.Then patients will be asked about their pain by co-researcher and according to VAS scale.
Category
Treatment - Drugs
3
Description
The third intervention is intramuscular magnesuim sulfate injection with Z technique with acupressure in UB32 point.Acupressure point is pressed by thumb directly and continuously with pressure equal to 4.5kg/cm2 for one minute followed by three times sequentially.Then 5cc of drug will be injected in that buttock immediately.Then patients will be asked to lie in the other side and acupressure will be done with same technique and pressure and the remaining 5cc will be injected to the other buttock.Then patients will be asked about their pain by co-researcher and according to VAS scale
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez,Zeinabie & shooshtary hospitals affiliated to Shiraz University of Medical Science
Full name of responsible person
Setare Nazaribin
Street address
Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Sciences
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Sayed Basir Hashemi
Street address
Central Building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Setare Nazaribin
Position
MSc in Nursing
Other areas of specialty/work
Street address
Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Sciences, Namazi Square
City
Shiraz
Postal code
Phone
+98 71 3825 2704
Fax
Email
setare1991_2013@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Saeed Najafi
Position
MS in Nursing
Other areas of specialty/work
Street address
Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Science, Namazi Square
City
Shiraz
Postal code
0098713451978
Phone
+98 71 3647 4255
Fax
+98 71 3831 5561
Email
najafisa@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Saeed Najafi
Position
MS in Nursing
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
najafisa@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)