Investigating the effect of pressure on GB21 on labor pain
Design
Clinical trial, community-based, and pragmatic control group, with parallel groups, blind, randomized,
Settings and conduct
Mothers who are admitted to the active phase of labor, selected according to inclosion criteria. After giving explanations to individuals, they are randomly divided into separate rooms. Intervention teams are unaware of how to intervene. How to handle the pain assessment The pain intensity before the intervention, immediately after the intervention, is 30 minutes and 60 minutes after the intervention using a pain reliever. The results are recorded in the checklist and the examination is recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: primiparous; age18-35 years; cephalic presentation; Gestational age 37-41 weeks; Singleton; ability to read and write; tendency to use analgesia; be in active phase;
Exclusion criteria: not having willingness to work with researcher; Conditions lead to cesarean section
Intervention groups
Pressure group on GB 21; Pressure group on shame point; Control group
In the pressure group on GB 21, the researcher pushes his right hand over the point. Using pressure during uterine contractions.
In the pressure group on the shame point with the conditions, the pressure is applied to theshame point.
In the control group, the researcher only performs the necessary measures in labor.
Main outcome variables
Severity of labor pain؛ Satisfaction of the treatment course
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100503003860N34
Registration date:2018-04-17, 1397/01/28
Registration timing:registered_while_recruiting
Last update:2018-04-17, 1397/01/28
Update count:1
Registration date
2018-04-17, 1397/01/28
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
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pressure on bile duct 21 on labor pain in primiparous women
Public title
The effect of pressure on bile duct 21 on labor pain in primiparous women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Be primiparous
cephalic presentation
ability to read and write
18-35years
Gestational age 37-41 weeks and Singletonage
tendency to use analgesia
be in active phase
Exclusion criteria:
Do not have to work with a researcher
Conditions lead to cesarean section
high risk pregnancies
skin disorders
chronic diseases
mental and anatomical disorders
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
174
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)
Single blinded
Blinding description
In this study, a full description of the research is given to the research units at first, and the patient is given written consent for participation in the study. Then Pregnant mothers are placed in separate rooms to avoid being aware of the intervention. In the control group only routine care is applied
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of beheshti university of medical sciences
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.SBMU.PHNM.1395.705
Health conditions studied
1
Description of health condition studied
labor pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of labor pain
Timepoint
Before the intervention,Immediately after intervention, 30 minutes and 60 minutes after intervention
Method of measurement
Numerical rating scale
Secondary outcomes
1
Description
Mode of delivery
Timepoint
once-after delivery
Method of measurement
Questioner
2
Description
Neonatal Apgar Score
Timepoint
1 and 5 minute after birth
Method of measurement
check list
Intervention groups
1
Description
first Intervention group: In the intervention group with acupressure on the bile duct 21, the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.
Category
Other
2
Description
Intervention group 2: The second group is pressure on shame point. This point is located between 1 and 2 thumbs from the point of the Gallbladder21 at the outside of the body.the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.
Category
Other
3
Description
Control group: The third group is the control group. This group receives all routine care except for intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofatheh Hospital in Varamin, affiliated to Shahid Beheshti University of Medical Sciences
Full name of responsible person
hamideh torkiyan
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
iranifarvahar@gmail.com
Web page address
http://nm.sbmu.ac.ir/?siteid=244
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
DR ABBAS RAHIMI
Street address
Vice Chancellor for research of Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 7756 1721
Email
arahimiuk@yahoo.com
Web page address
http://nm.sbmu.ac.ir/?siteid=244&pageid=11383
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, Shahid 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
Hamideh Torkiyan
Position
Graduate Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
iranifarvahar@gmail.com
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
Assistant professor, PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Valiasr Avenue, intersection of prayer facing Shahid Rajaee Heart Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218865536671
Email
g.ozgoli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamideh Torkiyan
Position
Midwifery Masters Degree
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Behehshti University of Medical Sciences, Faculty of Nursing and Midwifery, in frint of Shahid Rajaee Heart Hospital, Intersection of Niayesh, Valiasr St. Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218865536671
Email
iranifarvahar@gmail.com
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