Determining the comparison of the effect of Entonex gas with Bl32 and sp6 pressure points on labor pain, labor progress and labor outcomes in primiparous women referred to Taleghani Hospital in Ilam city in 1402
Design
The clinical trial has a control group, antonex and pressure points, with parallel groups, without blinding, block randomization on 90 people, stata software and ralloc package will be used for randomization.
Settings and conduct
This study is a practical plan in the field of natural childbirth by clinical trial method, which will be conducted in Taleghani maternity hospital in Ilam city and will be compared between three groups.
Participants/Inclusion and exclusion criteria
Prime women aged 18 to 35 with a singleton pregnancy
Cephalic position of the fetus
Not using other anesthesia methods
Active phase of labor
Intervention groups
Antonex Group
Group of pressure points
control group
Main outcome variables
Labor duration, labor pain and maternal and fetal complications after delivery
General information
Reason for update
Acronym
IEPS
IRCT registration information
IRCT registration number:IRCT20230717058818N1
Registration date:2023-08-21, 1402/05/30
Registration timing:registered_while_recruiting
Last update:2023-08-21, 1402/05/30
Update count:0
Registration date
2023-08-21, 1402/05/30
Registrant information
Name
Shaghayegh Gheitasiilami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3333 3333
Email address
gheitasi-s@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-11, 1402/05/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Entonex gas with Bl32 and sp6 pressure points on labor pain, labor stages and labor outcomes in primiparous women
Public title
Comparison of the effect of Entonex gas with Bl32 and sp6 pressure points on labor pain, labor stages and labor outcomes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Having literacy
Singleton pregnancy
Gestational age 37 to 41 weeks
Fetal cephalic status
Women being in the active phase
Not suffering from mental disorders
No Anatomical disorders
Not using other methods of anesthesia
Not using oxytocin to induce and strengthen labor
Exclusion criteria:
Multiple pregnancy
Mother's chronic illness
Skin diseases such as eczema
high risk pregnancy
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
After receiving written consent, 90 patients will be randomly divided into three groups: Entonex, acupressure, and control, so that there will be 30 people in each group. Balance block randomization method will be used for random and the stata software allocation of people and the ralloc package will be used to create a random sequence. .In this way, 6 blocks with 1 permutation will be created in the following order:
1=ABC
2=ACB
3=CAB
4=CBA
5=BCA
6=BAC
Where A represents the Entonex group, B represents the acupressure group and C represents the control group. Then, based on the numbers in the random table, a number will be chosen randomly, and based on the last digit on the right, one of the groups will be used to determine the sequence of randomization. It should be noted that if the number on the right is zero or 7 to 9 when choosing a random number, that number will not be considered and a random number will be selected again. This will continue until all 90 people are assigned to three groups. It should be noted that this method will prevent two groups from being unbalanced, as well as identifying the randomization sequence.
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 Ilam University of Medical Sciences
Street address
No.5.Resalat Ave,resalat street,Ilam Town
City
Ilam
Province
Ilam
Postal code
6931956599
Approval date
2023-06-14, 1402/03/24
Ethics committee reference number
IR.MEDILAM.REC.1402.077
Health conditions studied
1
Description of health condition studied
Labor duration, labor pain and maternal and fetal complications after delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Labor progress
Timepoint
4 cm dilatation, every one hour during intervention and after delivery
Method of measurement
Checklist of Duration of Labor Stages
2
Description
labor pain
Timepoint
one hour during labor
Method of measurement
Ten Degree Visual Analogue scale
3
Description
Maternal and Neonatal Outcomes
Timepoint
After giving birth and the day after giving birth
Method of measurement
Checklist of Maternal and Neonatal Outcomes
Secondary outcomes
1
Description
Maternal and neonatal complications after delivery
Timepoint
Before birth and one day after delivery
Method of measurement
Checklist of maternal and newborn outcomes designed by the researcher
Intervention groups
1
Description
Intervention group: entonex.Until the client learns how to use the Entonx mask and capsule and identify uterine contractions, the training will continue, and Entonx gas with a mask will be used as self-prescription from the beginning to the end of each uterine contraction.
Category
Rehabilitation
2
Description
Intervention group: point pressures.Acupressure will be performed at BL32 and SP6 points, and pressure will be applied during uterine contractions by two hands of the researcher on both sides. After 30 seconds of pressure, a 30-second rest will be given. In this way, it will continue for 20 minutes, and each time One of these two points is pressed bilaterally, and the instructor will stay with the researcher until the complete training on how to perform acupressure.
Category
Rehabilitation
3
Description
Control group: control.The control group received only routine measures.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani maternity hospital
Full name of responsible person
Dr Sajad Noorollahi
Street address
Khabarnegar Blvd,Ilam Town
City
Ilam
Province
Ilam
Postal code
6931875131
Phone
+98 84 3333 2471
Email
gheitasi-s@medilam.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Sobhan Ghaforian
Street address
Ilam University of Medical Sciences,Pazhohesh Blvd,Ilam Town
City
Ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3222 7134
Email
gheitasi-s@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Shaghayegh Gheitasiilami
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.5,Resalat Ave,Rasalat Street,Ilam Town
City
Ilam
Province
Ilam
Postal code
6831956599
Phone
+98 84 3333 3333
Email
gheitasi-s@medilam.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shaghayegh Gheitasiilami
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.5,Resalat Ave,Resalat Street,Ilam Town
City
Ilam
Province
Ilam
Postal code
6931956599
Phone
+98 84 3333 3333
Email
gheitasi-s@medilam.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shaghayegh Gheitasiilami
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.5,Resalat Ave,Rasalat Street,Ilam Town
City
Ilam
Province
Ilam
Postal code
6831956599
Phone
+98 84 3333 3333
Email
gheitasi-s@medilam.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Clinical study report, results are shared
When the data will become available and for how long
Access starts one year after the results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Analytical studies
From where data/document is obtainable
gheitasi-s@medilam.ac.ir
Shaghayegh Gheitasiilami
What processes are involved for a request to access data/document
Information will be sent after the request is reviewed and if the ethical points of the research and the consent of the participants are met.