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the Effect of Acupressure at GB21 on Childbirth Experience During First Stage of Labour, a clinical trial study

Protocol summary

Study aim
Comparing the mean scores of childbirth experience in women admitted to Nik Nafs Maternity Hospital in Rafsanjan receiving acupressure at point GB21, those receiving gentle touch, and the control group.
Design
the required sample size is 64 individuals per group. In total, 192 eligible women are required to conduct this study.
Settings and conduct
This study is a controlled randomized clinical trial. The statistical population consists of all women admitted to Nik Nafs Hospital in Rafsanjan for natural childbirth Pregnant women who meet the study's inclusion criteria and sign the informed consent form will be randomly assigned to one of the following three groups: Acupressure Group (APG) Gentle Touch Group (TG) Control Group (receiving routine care) After signing and confirming the informed consent form and prior to randomization, baseline information—such as demographic and social data—will be asked and completed by a research specialist.
Participants/Inclusion and exclusion criteria
Inclusion criteria for the trial consisted of: willingness to participate in the study, singleton pregnancy and absence of high-risk pregnancies and Exclusion criteria included: unwillingness to cooperate during the interview, need for an emergency cesarean section, and use of pain relief methods.
Intervention groups
In the acupressure group (APG), participants will be positioned appropriately, and the GB21 acupressure point will be pressed by a trained specialist. In the sham acupressure group (TG), the target point will only be touched and not pressed.
Main outcome variables
Birth experience

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181219042051N5
Registration date: 2025-12-20, 1404/09/29
Registration timing: registered_while_recruiting

Last update: 2025-12-20, 1404/09/29
Update count: 0
Registration date
2025-12-20, 1404/09/29
Registrant information
Name
Zohreh Ghorashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
zghorashi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-11, 1404/09/20
Expected recruitment end date
2026-05-10, 1405/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the Effect of Acupressure at GB21 on Childbirth Experience During First Stage of Labour, a clinical trial study
Public title
the Effect of Acupressure at GB21 on Childbirth Experience During First Stage of Labour
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study gestational age of 37-42 weeks maternal age of 18-45 years ability to speak Persian absence of high-risk pregnancies (gestational hypertension, reduced fetal movements, intrauterine growth restriction, fetal death, poly- or oligohydramnios, rupture of membranes for more than 12 hours, history of infertility, gestational diabetes, smoking) absence of chronic diseases (heart disease, lung disease, diabetes, and hypertension) cephalic presentation of the fetus absence of an accompanying midwife no history of physical, surgical, or psychological problems no issues during pregnancy singleton pregnancy
Exclusion criteria:
Unwillingness to cooperate during the interview need for emergency cesarean section use of pain relief methods.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 192
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the inclusion and exclusion criteria, 192 pregnant women at 37-42 weeks of gestation who were eligible to enter the study were selected using an available sampling method. They will be divided into three equal groups of 64 individuals using blocked randomization with a block size of six (via the computer program "CREATE A RANDOMISATION LIST"). In other words, 32 blocks of six individuals will be formed. Within each block, two individuals will be randomly assigned to the first group (APG), two to the second group, and two to the third group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rafsanjan University of medical sciences ethics committee
Street address
Parastar Street
City
Rafsanjan
Province
Kerman
Postal code
771869669
Approval date
2025-03-11, 1403/12/21
Ethics committee reference number
IR.RUMS.REC.1403.217

Health conditions studied

1

Description of health condition studied
birth experience
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Birth experience
Timepoint
one hour after birth
Method of measurement
Childbirth Experience Questionnaire Ghanbari-Homayi

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: first. acupuncture point pressure In the acupressure group (APG), participants will be positioned appropriately and the GB21 acupressure point will be pressed by a trained specialist. The Gallbladder 21 point is located on the gallbladder meridian, and its anatomical position is on the shoulder, midway between the acromion bone and the seventh cervical vertebra. Pressure will be applied starting from the onset of contractions (3-4 cm cervical dilation) and continued throughout the active phase of labor (7-8 cm cervical dilation) until the end of the first stage of labor. During the procedure, in the GB21 pressure group, the mother will be asked to assume any comfortable position. The intervening midwife will stand facing the mother and monitored her uterine contractions by hand to detect their onset. At the start of each contraction, the two symmetrical target points will be pressed simultaneously and symmetrically with both hands, five times in a row. Each press will laste 10 seconds, followed by a 2-second release and rest period. The intervener aime to apply a consistent and equal amount of pressure each time. Any difference in pressure applied by the left and right thumbs will be minimized through practice and training.
Category
Treatment - Other

2

Description
Intervention group: second. acupuncture point touch In the sham acupressure group (TG), the target point will only touch and not pressed.
Category
Treatment - Other

3

Description
Control group: routine care the control group will receive just routine care.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nik nafs hospital
Full name of responsible person
Zohreh Ghorashi
Street address
Parastar Street
City
Rafsanjan
Province
Kerman
Postal code
771869669
Phone
+98 34 3425 5900
Email
zghorashi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Hamid Hakimi
Street address
Imam Ali Street
City
Rafsanjan
Province
Kerman
Postal code
771869669
Phone
+98 34 3425 5900
Email
zghorashi@yahoo.com
Grant name
Grant code / Reference number
403250
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Zohreh Ghorashi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Parastar Street
City
Rafsanjan
Province
Kerman
Postal code
771869669
Phone
+98 34 3425 5900
Email
zghorashi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Zohreh Ghorashi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Parastar Street
City
Rafsanjan
Province
Kerman
Postal code
771869669
Phone
+98 34 3425 5900
Email
zghorashi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Zohreh Ghorashi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Parastar Street
City
Rafsanjan
Province
Kerman
Postal code
771869669
Phone
+98 34 3425 5900
Email
zghorashi@yahoo.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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