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The effect of acupuncture in reducing the labor pain in mothers referred to Akbrabadi ‎hospital in 2021, a randomized clinical trial.‎

Protocol summary

Study aim
Study of the effect of acupuncture in reducing the pain of natural childbirth in mothers.
Design
A clinical trial with a control group, with parallel groups, single blind, randomized, worked on 32 patients. Also, the random function of Excel software was used for randomization.
Settings and conduct
The study design is a single-blind randomized clinical trial intervention. Sampling of patients referred to Akbarabadi Obstetrics and Gynecology Center.
Participants/Inclusion and exclusion criteria
The Criteria for inclusion in this study are: The Single pregnant women, Normal BMI (19.8-26), Number of the deliveries less than or equal to 1, the Fluency in Persian to understand information, Term pregnancy (37 to 40 weeks) based on ultrasound under 20 weeks, Dilatation 5 cm, the Proper uterine contraction In terms of number, duration and intensity, lasting more than 30 seconds and less than ten minutes apart, regular heart beat, normal fetal presentation, the spontaneous onset of the labor, no obstetric problems and no disease. Exclusion criteria include patient disagreement with the design and provisions of the stillbirth consent form, the multiple incomplete pregnancies, abortion, neonates, and major congenital anomalies (including: life-threatening, need for major surgery, Chromosomal trisomies), the presence of maternal medical diseases (preeclampsia, thrombophilia, hypertension) and the presence of PPROM, HTN, oligohydraminosis, amniotic fluid disorder , cesarean section, use of fetal heart monitor due to fetal distress.
Intervention groups
The intervention group is performed acupuncture in real areas, including: SP6-Sp9 - St36-Li4 - Li3.
Main outcome variables
The Reduction of labor pains as well as duration of the delivery time was seen significantly in the intervention group.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220303054175N1
Registration date: 2022-03-26, 1401/01/06
Registration timing: retrospective

Last update: 2022-03-26, 1401/01/06
Update count: 0
Registration date
2022-03-26, 1401/01/06
Registrant information
Name
Mohammad Reza Hashtroudi
Name of organization / entity
Akbar Abadi Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 6034
Email address
dr.hashtroudi.md@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-31, 1399/08/10
Expected recruitment end date
2021-02-12, 1399/11/24
Actual recruitment start date
2021-01-10, 1399/10/21
Actual recruitment end date
2021-02-12, 1399/11/24
Trial completion date
2021-02-27, 1399/12/09
Scientific title
The effect of acupuncture in reducing the labor pain in mothers referred to Akbrabadi ‎hospital in 2021, a randomized clinical trial.‎
Public title
The effect of acupuncture in reducing the labor pain in mothers referred to Akbrabadi ‎hospital in 2021, a randomized clinical trial.‎
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ُSُingleton Pregnant mothers,Normal BMI (19.8-26),Number of deliveries equal to or less 1,Fluency in Persian to understand information,Term pregnancy (37 to 40 weeks) based on ultrasound under 20 weeks,Dilatation 5 cm,Proper uterine contraction in terms of number,Duration and intensity lasting more than 30 seconds and less than ten minutes apart,Regular heart rate,Natural display of the fetus,Spontaneous onset of labor,Do not have any obstetric problems and do not have the disease.
Exclusion criteria:
Patient's disagreement with entering the plan and provisions of the stillbirth consent form,Multiple miscarriages, with abortions,Neonates and congenital anomalies of major (including: life-threatening, need for major surgery, chromosomal trisomies), presence of maternal medical diseases (preeclampsia, thrombophilia, hypertension) and presence of PRROM, HTN, oligohydramenosis, amniotic fluid disorder, Previous cesarean section and use of fetal heart monitor due to fetal distress.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 32
Actual sample size reached: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects (intervention group and main group) are placed in one of the two intervention or control groups, through a table of random numbers and blocking.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, which is a randomized clinical trial (RCT) of single blind, all participants in both intervention and control groups were unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
In this method we use acupuncture which is the safest and cheapest way to reduce pain. By examining the effect of adding three new points, which are ST36, Li3, and SP9, and in comparison with previous international research, which focuses more on two points, SP6 and Li4, and also using Electrical stimulation will be able to measure the reduction of labor pain.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of] IRAN University of Medical Sciences
Street address
Tehran Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
14496145351
Approval date
2021-01-02, 1399/10/13
Ethics committee reference number
IR.IUMS.FMD.REC.1399.612

Health conditions studied

1

Description of health condition studied
Reducing the labor pains in the normal vaginal delivery by the acupuncture
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Study and evaluation of the effects of the acupuncture in reducing the delivery pains by stimulating the real points in this study which is selected as follows: SP6 -Sp9 -St36 -Li3-Li4.
Timepoint
The measurement of reducing the pain at this stage will compare in the period of 15 minutes - 30 minutes - 45 minutes.
Method of measurement
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

Secondary outcomes

1

Description
Study and evaluation of the effect of the acupuncture in reducing the delivery pains by stimulating the unreal points in this study which is selected as follows: : LU5, LU6, LU8, ST39
Timepoint
The measurement of reducing the pain at this stage will compare in the period of 15 minutes - 30 minutes - 45 minutes.
Method of measurement
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

Intervention groups

1

Description
Intervention group: Intervention group with acupuncture will includes the real points which following : SP6 -Sp9 -St36 -Li3-Li4
Category
Treatment - Other

2

Description
Control group: In contrast with the intervention group,there is a simulated control group, which considered by observing the entry and exit criteria, whose members receive acupuncture in insensitive areas to finally compare their results with the intervention group.The main acupuncture points of this group includes : LU5, LU6, LU8, ST3
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Maryam Rahimi
Street address
Mowlavi St., Ferdows Gardens Station
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5563 7048
Fax
+98 21 5560 8012
Email
rahimi.m@iums.ac.ir
Web page address
https://crta.iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Ahmad Hormati
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran, IRAN
City
TEHRAN
Province
Tehran
Postal code
14496145351
Phone
+98 21 8670 2030
Fax
+98 21 8862 2692
Email
research-m @iums.ac.ir
Web page address
https://iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mohammad Reza Hashtroudi
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Hashtroudi
Position
Medical Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
dr.hashtroudi.md@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Rahimi
Position
Assistant Professor,Consultant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Fax
+98 21 5560 8012
Email
rahimi.m@iums.ac.ir
Web page address
https://crta.iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Hashtroudi
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
َAlternative medicine-acupuncture
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 5560 6034
Email
dr.hashtroudi.md@gmail.com
Web page address
https://iums.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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