Protocol summary

Study aim
The effect of acupressure on the LI4 point on the completion of the labor process and the active phase of labor
Design
A randomized controlled trial ، 60 subjects (30 in each group)
Settings and conduct
Mashhad, Um al-Banin's Hospital, Satisfaction of participation in the project, filling in the demographic information questionnaire, randomized categorization into two groups
Participants/Inclusion and exclusion criteria
Satisfaction of the company in the design, age 18-35, 37-41 weeks of pregnancy, first to third pregnancy, 5-4 cm cervical dilatation, onset of self-perception, cephalopelvic fitness, no previous risk factors for pregnancy and childbirth, no previous cesarean section , Lack of addiction and dependence on substance or drug, lack of acupressure, health of the LI4 region in terms of burn, injury, sensitivity and irritability, with a single fetus with cephalic and anthiur status؛ use of chemical and herbal medicines in the last 24 hours and high risk pregnancies
Intervention groups
In the intervention group, pressure on the LI4 point begins simultaneously with the onset of uterine contraction and lasts for one minute. 5 pressure periods are performed on the LI4 point per minute;Each period lasts 10 seconds and then 2 seconds rest and then the next period begins In the control group, acupressure is not used
Main outcome variables
Cervical dilatation before and after intervention, every 120 minutes until the third stage of labor begins

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180411039264N1
Registration date: 2019-02-10, 1397/11/21
Registration timing: registered_while_recruiting

Last update: 2019-02-10, 1397/11/21
Update count: 0
Registration date
2019-02-10, 1397/11/21
Registrant information
Name
maryam shariatjafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2608
Email address
shariatjm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on LI4 point on duration of active phase of labour
Public title
The effect of acupressure on the course of labour
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction of the company in the design Aged 18-35 gestational age 37-41 Pregnancy first to third 5-4 cm cervical dilatation with onset Proportion of cephalopelvic Lack of previous risk factors for pregnancy and childbirth No previous cesarean section Lack of addiction and substance or drug dependence Lack of acupressure experience The health of the LI4 region for burn, injury, sensitivity and irritability Embryo unit with cephalo anterior status.
Exclusion criteria:
Use of chemical and herbal medicines in the last 24 hours high risk pregnancy
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization Random unit: Individual Randomization Tool: Packed Envelopes How to create a random sequence: computer software Hiding: The envelopes containing the grouping type (intervention and control group) are prepared according to the random allocation list by a person outside the plan and numbered accordingly. . The envelope is provided to the trained midwife, for each mother, a pocked will be opened to determine which mother is in the group
Blinding (investigator's opinion)
Double blinded
Blinding description
The envelopes containing the grouping type (intervention and control group) are prepared according to the random allocation list by someone outside the plan and numbered accordingly. The envelope is provided to trained midwife, for each mother, a pocked will be opened in order to determine which mother is in the group. Since the outcome evaluator is the midwife of the patiente, the investigator and the data analyzer are unaware of the outcome and are not involved in the registration and evaluation of the outcome.
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
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2017-12-20, 1396/09/29
Ethics committee reference number
IR.MUMS.FM.REC.1396.614

Health conditions studied

1

Description of health condition studied
pregnancy
ICD-10 code
O00.0
ICD-10 code description
Abdominal pregnancy

Primary outcomes

1

Description
Active phase length of labor
Timepoint
The beginning of the active phase (before the intervention)،Every 2 hours until delivery
Method of measurement
touche vaginal

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Pressing the LI4 point that is the point behind The hand between the first and second metacarpal bones and at the midpoint of the bone of the second metacarpal and close to the radius bone At the onset of the active phase of labor with a cervical dilatation of 5-4 cm, the pressure period At the same time, the uterine contraction begins and lasts for one minute.5 pressure cycles at the LI4 point per minute; each period lasts 10 seconds And then 2 seconds rest is ahead, and then the next period begins. This cycle continues until the birth of the baby
Category
Treatment - Other

2

Description
Control group: Acupressure is not used in them
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Omalbanin hospital
Full name of responsible person
Salmeh Dadgar
Street address
No16, Ayatollah Bahjat Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9144663595
Phone
+98 51 3223 1061
Email
dadgars@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
Deputy of Research and Technology .,Mashhad University of Medical Sciences ., opposite Daneshgah 18., Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
91357-345
Phone
+98 51 3882 3255
Email
Tafaghodim@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
Mashhad University of Medical Sciences
Full name of responsible person
Dadgar Salameh
Position
Assisstant Professor of obstetrics and gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital., Emam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2608
Email
dadgars@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dadgar Salameh
Position
Assisstant Professor of obstetrics and gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital ., Emam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2608
Email
dadgars@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Shariatjafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Ebn Sina St., Emam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2608
Fax
Email
shariatjm951@mums.ac.ir

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
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