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Comparison of the effect of pressure on Sanynjiao (SP6) and Gallbladder21(GB21) points on labor pain intensity in primiparous women

Protocol summary

Study aim
Comparison of the effect of pressure on (GB21) and (SP6) points on the severity of labor pain in primiparous women.
Design
The intervention takes place in three groups, two acupressure groups and one control group, where the samples are grouped by simple randomization method of 3 and 6 through the website https://www.sealedenvelope.com.
Settings and conduct
In Kashan maternity hospitals, the intervention is performed on primiparous women who have dilation of 6-/5 cm in the form of 30 s, 30s rests for 20 minutes every one hour until delivery.
Participants/Inclusion and exclusion criteria
Iranian women, first-time mothers, aged 18 to 35 years, with singleton pregnancies, gestational age between 37 to 41 weeks, presenting with a cephalic fetal position, being in the active phase of labor , having a natural and low-risk delivery, not suffering from skin disorders , being in good physical health with no limitations for intervention, rupture of the amniotic sac, not using spinal or epidural anesthesia, completion of a written consent form, and not utilizing other complementary methods for pain relief during the study. Exclusion criteria: In case of any complications during labor requiring cesarean section, rapid delivery, or lack of cooperation in undergoing acupressure by the patient.
Intervention groups
The intervention will be done in three groups as follows: In the first intervention group (pressure on SP6 point) In the second intervention group (pressure on GB21 point) In the control group, pressure will be applied on the ineffective point
Main outcome variables
Pain intensity, acupressure, , length of active stage of labor, length of latent phase, companionship,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241203063925N1
Registration date: 2025-09-25, 1404/07/03
Registration timing: retrospective

Last update: 2025-09-25, 1404/07/03
Update count: 0
Registration date
2025-09-25, 1404/07/03
Registrant information
Name
Hadiseh Habibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4462 3868
Email address
hadis.habibi0102@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-03, 1403/10/14
Expected recruitment end date
2025-09-05, 1404/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of pressure on Sanynjiao (SP6) and Gallbladder21(GB21) points on labor pain intensity in primiparous women
Public title
effect of acupressure on the intensity of labor pain in primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian women first born 18 to 35 years singleton pregnancy Gestational age 37 to 41 weeks Cephalic presentation of the fetus Women being in the active phase of labor (dilation 5 to 10 cm) Having a natural and low-risk delivery Not suffering from skin problems such as eczema and skin surface infections, which are among the limitations of performing acupressure. having physical health and not having any restrictions for intervention (pre-eclampsia, convulsions, paroxysms of the curtains) Rupture of water bag Not using spinal and epidural anesthesia Completing the written consent form Not using other complementary medicine methods to reduce pain while studying
Exclusion criteria:
In case of any complications during labor Need for caesarean section quick delivery Non-cooperation in acupressure
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, at first, the samples will be selected through available sampling, and then they will be randomly divided into three groups by random blocks of 3, 6 through the website https://www.sealedenvelope.com.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Ravand. 57 Hekmat Street, Beheshti Hospital
City
kashan
Province
Isfehan
Postal code
8715973474
Approval date
2025-02-04, 1403/11/16
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1403.042

Health conditions studied

1

Description of health condition studied
The effect of acupressure on pain intensity in primiparous pregnant women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
intensity of pain
Timepoint
Before the intervention, immediately, one hour and two hours after the intervention
Method of measurement
Pain Visual Scale Questionnaire(VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first intervention group (control group): pressure on the misplaced point.
Category
Treatment - Other

2

Description
Intervention group: pressure on the SP6 point.Thirty seconds of pressure and then thirty seconds of rest on the desired point for 20 minutes. SP6 location: The sp6 or 6 spleen point is located on both feet at a point 4 finger widths apart, above the inner ankle bone and behind the tibia.
Category
Treatment - Other

3

Description
Intervention group: pressure on the GB21 point.Thirty seconds of pressure and then thirty seconds of rest on the desired point for 20 minutes. GB21 Location: Gallbladder point 21 is located on the gallbladder meridian. Its anatomical location is on the shoulder between the acromion bone and the seventh cervical vertebra.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
1. Kashan shabih_khani hospital 2. Shahid Beheshti hospital, Kashan
Full name of responsible person
Dr. Fatemeh Abbaszadeh
Street address
Shahid Beheshti Hospital. 57 Hekmat St. Rawand St
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5500 5561
Email
hadis.habibi0102@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Abaszadeh
Street address
Kashan University of Medical Sciences,.57Hekmat St., Qutb Rawand
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5500 5561
Email
hadis.habibi0102@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Hadiseh Habibi
Position
Midwifery master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Imam Street of Shahid Beheshti Hospital
City
Bandare_Anzahi
Province
Guilan
Postal code
4319893151
Phone
9844505212
Email
hadis.habibi0102@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hadiseh Habibi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Vahdat
City
Rezvanshahr
Province
Guilan
Postal code
4384115969
Phone
+98 13 4462 3868
Fax
Email
hadis.habibi0102@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hadiseh Habibi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Vahdat
City
Rezvanshahr
Province
Guilan
Postal code
4384115969
Phone
+98 13 4462 3868
Fax
Email
hadis.habibi0102@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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