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Comparison of the effect of acupressure at SP6 and SP8 points on severity of labor pain and duration of first stage of labor

Protocol summary

Study aim
Determining the effect and comparison of acupressure in SP6 and SP8 points on the severity of pain and duration of the first stage of labor
Design
The study of a clinical trial with a control group, a blind side, is parallel. Randomization is done by the function of random numbers and using the rand function of Excel software.
Settings and conduct
This clinical trial is performed on pregnant clients at Akbar Abadi Hospital in Tehran. Acupressure is performed with the thumbs vertically at points SP8 and SP6 and the neutral point at the beginning of contraction for 20 minutes continuously in each dilatation 3-4 cm, 5-7 cm and 10-8 cm. In the meanwhile, the average severity of pain recorded before the intervention began was immediately compared (after the end of acupressure) and 30 and 60 minutes after the intervention in 3-4 cm, 7-5 cm and 10-8 cm dilatation in three groups.The length of the first stage of labor will be measured by the researcher in three groups using a timer. Examples show that one of the three points is pressed and may be part of the intervention or control group.
Participants/Inclusion and exclusion criteria
Entry requirements include pregnant women aged 18-35, with no previous high-risk disease, term embryos, cephalic, unicellular, with 4-3 dilatations when hospitalized. Samples are removed from the study if there is no urgency and emergency cesarean section.
Intervention groups
The first group applied acupressure at point SP6 and the second group at point SP8, and the third group applied acupressure at point zero, which is 2 cm lower and 1 cm behind point SP8. they will receive for 20 minutes continuously in each dilatation 3-4 cm and 5-7 cm and 10-8 cm.
Main outcome variables
The severity of the pain The length of the first stage of labor Type of treatment (acupressure) Oxytocin consumption Taking medicine to reduce pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200610047717N1
Registration date: 2020-07-27, 1399/05/06
Registration timing: registered_while_recruiting

Last update: 2020-07-27, 1399/05/06
Update count: 0
Registration date
2020-07-27, 1399/05/06
Registrant information
Name
Mona Jalilabadi Oshtarkan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7748 3579
Email address
itsmonajalilabadi75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-19, 1399/02/30
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of acupressure at SP6 and SP8 points on severity of labor pain and duration of first stage of labor
Public title
effect of acupressure on severity of labor pain and duration of first stage of labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-35 Have at least literacy Spontaneous onset of labor pains and a desire to have a normal delivery When hospitalized, dilate 3-4 cm. According to the mother, they should not be addicted to drugs and tobacco. ccording to the mother, they do not have family problems in the last 6 months and severe psychological crises such as the death of loved ones, migration, separation from their spouses, and so on. According to the mother, they do not have chronic diseases (heart disease, lung disease, high blood pressure, diabetes, etc.). Do not have high-risk pregnancies (gestational hypertension, gestational diabetes, placenta previa, decolman). Do not suffer from skin disorders such as eczema and superficial skin infections, which are some of the limitations of acupressure. The fetus should be single, alive, cephalic There are no high-risk fetal criteria (fetal heart failure, decreased fetal movement, intrauterine growth restriction, polyhydramnios, and oligohydramnios known by ultrasound and amniotic sac rupture for more than 12 hours).
Exclusion criteria:
People who do not want to continue studying. Examples that will require emergency cesarean section.
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: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Random number functions will be used to randomize and assign individuals to groups. This is done by Excel software and a random number table. In this way, first in a column, the groups are entered as A, B, C and below. Because the number of samples in each group is set to 50 (including sample shedding), 150 to A, B, and C must be entered in the following order. In the opposite column, random numbers are generated using the RAND command. In the next step, using the SORT command, random numbers generated from small to large or vice versa are arranged, which changes the order of the groups. Using the new order, people are assigned to different groups. People are unaware of which group they belong to.
Blinding (investigator's opinion)
Single blinded
Blinding description
The subjects will be explained that this is a study that will put pressure on one of the three points of interest. These points may or may not reduce the pain and length of the first stage of labor. People will be randomly placed in one of these three groups and pressure will be applied to the desired point. Patients understand acupressure but do not know the names of the points and which point is for intervention and which point is for control. They do not know the exact use of the points and only know that they belong to one of the three groups that receive acupressure at one of the three points and that the points can reduce labor pain and the length of labor or not.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research, School of Pharmacy, Nursing and Midwifery, Shahid Beheshti University
Street address
Shahid Beheshti School of Nursing and Midwifery., Opposite Shahid Rajaei Heart Hospital, Niayesh Intersection, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.289

Health conditions studied

1

Description of health condition studied
Labor pain
ICD-10 code
ICD-10 code description

2

Description of health condition studied
The length of the first stage of labor
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Labor pain
Timepoint
before the intervention, Immediately, 15 minutes and 30 minutes after the intervention
Method of measurement
Numerical rating scale

2

Description
The length of the first stage of labor
Timepoint
From dilatation 3 cm to 10 cm
Method of measurement
Timer( Seiko watch)

Secondary outcomes

1

Description
intensity of labor pain
Timepoint
Intensity of labor pain is measured in dilatations of 3-4 cm, 5-7 cm, 10-8 cm. These measurements are taken immediately, 15 minutes and 30 minutes after acupressure.
Method of measurement
Pain measuring ruler (numerical rating scale)

2

Description
The length of the first stage of labor
Timepoint
The length of the first stage of labor is measured from dilatation 3-4 cm to 10 cm.
Method of measurement
The length of the first stage of labor is measured according to the official national clock of the Seiko model.

Intervention groups

1

Description
Intervention group: Compression at SP6 points. Perform acupressure with thumbs and vertically at SP6 points with the onset of contraction for 20 minutes continuously in each dilatation 3-4 cm and 5-7 cm and 10-8 cm
Category
Treatment - Other

2

Description
Intervention group: Compression medicine at SP8 points. Perform acupressure with thumbs and vertically at SP8 points with the onset of contraction for 20 minutes continuously in each dilatation 3-4 cm and 5-5 cm and 10-8 cm
Category
Treatment - Other

3

Description
Control group: Compression in control points. Perform acupressure with thumbs and vertically at the control points (2 cm lower and 1 cm back from the SP8 point) with the onset of contraction for 20 minutes continuously in each dilatation 3-4 cm and 7- 5 cm and 10-8 cm. It should be noted that according to the project's expert consultant, this point is neutral in terms of acupressure.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbarabadi Hospital in Tehran
Full name of responsible person
Mona Jalilabadi Oshtarkan
Street address
Bagh Ferdos Station, Molavi Street. Akbar Abadi Hospital
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences., next to Taleghani Hospital,. Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Fax
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Sedigheh Amir Ali Akbari
Position
Faculty instructor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti School of Nursing and Midwifery., Opposite Shahid Rajaei Heart Hospital, Niayesh Intersection, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sedaliakbari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedigheh Amir Ali Akbari
Position
Faculty instructor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti School of Nursing and Midwifery., Opposite Shahid Rajaei Heart Hospital, Niayesh Intersection, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sedaliakbari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedigheh Amir Ali Akbari
Position
Faculty instructor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti School of Nursing and Midwifery., Opposite Shahid Rajaei Heart Hospital, Niayesh Intersection, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sedaliakbari@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
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