Effect of Acupressure of Liver Point 3 on Reducing Postpartum Pain
Design
Clinical trials with control group, community based and pragmatic, with parallel groups, not blinded, randomized,
Settings and conduct
Selection of subjects with admission criteria followed by pain intensity determination based on pain ruler. have 4 score or more, they will enter the research. Individuals are randomly assigned to 3 groups in separate rooms. The severity of pain before the intervention is 30 and 120 minutes after the intervention. The results are recorded in the checklist and the examination is recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian - Minimum Reading and Writing Validity - All 20-35 years old mothers with postpartum pain with 4 score and more - Vaginal delivery - 38 weeks pregnancy and more - Not used for epidural anesthesia - Non- Drug user- No problems in the legs - no medical or mental illness - lack of family conflicts - pregnancy Unwanted - have a baby alive and without abnormality.
Exclusion criteria: Unwillingness to continue cooperation - Mother's need for surgery and anesthetic drug - Mother clearance with personal consent earlier than 12 hours.
Intervention groups
Intervention group: Acupressure at the 3rd Liver
Control group: Ibuprofen capsules every 6 hours to 24 hours
Control group: acupressure at the point of inactivity
Main outcome variables
Postpartum pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100503003860N35
Registration date:2018-05-09, 1397/02/19
Registration timing:registered_while_recruiting
Last update:2018-05-09, 1397/02/19
Update count:0
Registration date
2018-05-09, 1397/02/19
Registrant information
Name
Gity Ozgoli
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
gozgoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupressure point Liv3 on postpartum pain reduction
Public title
Effect of Acupressure Point Liv3 on postpartum pain reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- be Iranian. 2- Have at least the ability to read and write. 3- All 20-35 years-old mothers who have complained of postpartum pain and at least two hours have passed since their delivery and report a score of 4 or more on the basis of a pain ruler. 4- Child birth by vaginal delivery. 5- To have Gestational age 38 weeks or more. 6- Not used for epidural anesthesia. 7- No drug or alcohol addiction. 8- Do not smoke. 9- There are no Skin disease, mole, burnt, wound, fracture, tendon and muscle problems in the legs. 10- There are no known medical or mental illnesses based on the case (liver diseases, diabetes, coagulation disorders, hemophilia, immune deficiency). 11- There are no conflicts and family conflicts and severe financial problems during the last 6 months. 12- Pregnancy is unwanted. 13- Have a baby live and without abnormalities.
Exclusion criteria:
1- Do not wish to continue with the researcher. 2- Mothers who need surgery and receive postpartum anesthetic. 3- Mothers who have been discharged with personal satisfaction before 12 hours.
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The appointment of individuals in groups was randomized using the RANDOM ALLOCATION SOFTWARE FOR CLINICAL TRIAL software. Using this software, information about the sample number, the number of groups, the groups names will be taken into the data and output software, which includes the list of random groups of the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
After explaining the research to the research units, the researcher is considered as a sample of research if they are willing to participate in the study and having the characteristics of the research units and the absence of a ban on entry into the study.The appointment of individuals in groups was randomized using the RANDOM ALLOCATION SOFTWARE FOR CLINICAL TRIAL software.In the next step, people will randomly assign to one of the 3 groups according to the entry number and each group is placed in a separate room to avoid becoming aware of how the work is done in other groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences , Faculty of Nursing and Midwifery, Intersection of niayesh, in front of Shahid Rajaee Heart Hospital, Valiasr St.,Tehran
City
TEHRAN
Province
Tehran
Postal code
1985717443
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IR.SBMU.PHNM.1396.763
Health conditions studied
1
Description of health condition studied
Postpartum pain
ICD-10 code
Z39.2
ICD-10 code description
Routine postpartum follow-up
Primary outcomes
1
Description
Post-partum pain
Timepoint
Before the intervention, 30 minutes and 2 hours after taking the pill, every 6 hours after the intervention
Method of measurement
Pain ruler (numerical scale)
Secondary outcomes
1
Description
Description: Possible side effects of intervention
Timepoint
Timepoint: At the end of intervention period
Method of measurement
Method of measurement: At the end of the intervention period
Intervention groups
1
Description
Intervention group: 1 Acupressure 3rd point Liver every 6 hours for 24 hours
Category
Treatment - Other
2
Description
Control group: Ibuprofen tablet every 6 hours for 24 hours
Category
Treatment - Drugs
3
Description
Control group: Sham point acupressure every 6 hours for 24 hours
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Shahid Sadoughi Hospital
Full name of responsible person
Mahdieh Abouei Mehrizi
Street address
Ebne Sina Street, Shahid Ghandi Bulvard, Yazd
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
Sadoghi-hospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dept. of Research, School of Nursing and Midwifery, Shaheed Beheshti University of Medical Sciences
Full name of responsible person
Dolatian Mahrokh
Street address
Shahid Beheshti University of Medical Sciences, Faculty of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital, Intersection of niayesh, Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2518
Fax
Email
mhdolatian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dept. of Research, School of Nursing and Midwifery, Shaheed Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdieh Abouei Mehrizi
Position
دانشجوی کارشناسی ارشد مامایی
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti University of Medical Sciences, Faculty of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital, Intersection of Niayesh, Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
mahdiehabouei1357@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gity Ozgoli
Position
Ph.D. in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti University of Medical Sciences, Faculty of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital, Intersection of niayesh, Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
+98 21 8820 2521
Email
g.ozgoli@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdieh Abouei Mehrizi
Position
Midwifery Master's Degree
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti University of Medical Sciences, Faculty of Nursing and Midwifery,in front of Shahid Rajaee Heart Hospital, Intersection of Niayesh, Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
mahdiehabouei1357@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available