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Comparison of the effect of walking and using ball on labor intensity and duration of labor in primipar mothers

Protocol summary

Study aim
Comparison of the effect of walking in labor and the use of delivery balls on the duration and severity of labor pain in nulliparous women
Design
This study is a clinical trial study in which 40 people in the first intervention group, 40 people in the second intervention group and 40 people in the control group are selected and enter the study and people from different groups are not in contact with each other. Sampling method is available and simple random assignment and random number table are used. If the numbers 1, 2, and 3 are selected, the individuals are in group A (delivery ball), the numbers 4, 5, and 6 are in group B (walking), and the numbers 7, 8, and 9 are in group C (control group).
Settings and conduct
The location of the project is Razi Hospital in Ahvaz. In the intermittent or intermittent ball group, sit on the ball for at least 15 minutes per hour and move the pelvis forward, backward, left and right. In the intermittent or intermittent walking group. Walk for at least 15 minutes during one hour, and if the mother is in the control group, she does not have a dominant position and is free.
Participants/Inclusion and exclusion criteria
Low-risk nulliparous pregnant women; Term pregnancy; Single pregnancy ; Cephalic display; NST satisfactory; Spontaneous and painless labor; Accept participation in the study Taking physiological delivery classes;
Intervention groups
This study consists of three groups. There are two intervention groups and one control group. The first intervention group is the effect of walking and the second intervention group is the effect of the delivery ball.
Main outcome variables
walk Childbirth ball Intensity of pain in the active phase of labor Intensity of pain in the second stage of labor The length of the active phase of labor The length of the second stage of labor Mother's age BMI Economic level education Job

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200816048429N1
Registration date: 2020-10-10, 1399/07/19
Registration timing: registered_while_recruiting

Last update: 2020-10-10, 1399/07/19
Update count: 0
Registration date
2020-10-10, 1399/07/19
Registrant information
Name
Samira Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3252 3020
Email address
sam.maleki69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of walking and using ball on labor intensity and duration of labor in primipar mothers
Public title
"Walking and using ball on labor"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Low-risk primiparous pregnant women; Term pregnancy; Single pregnancy; Cephalic presentation; Satisfactory NST; Labor spontaneously and without Analgesia؛ Accept participation in the study؛ Passing physiological delivery classes.
Exclusion criteria:
Women with maternal fetal complication; Fetus with abnormal Presentation and condition; Pelvic stenosis; Oligo Hydramnius; Road pair and decoy; Use of analgesia and oxytocin; The need for oxytocin to induce and accelerate labor; Creating any problem in the delivery process that requires midwifery interventions.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
A table of random numbers is used; If the numbers 1, 2, 3 are selected; the people are in group A (delivery ball) and the numbers 4, 5, 6 are in group B (walking) and the numbers 7, 8, 9 are in group C ( Control group).
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 in Biomedical Research
Street address
Golestan Blv, Nursing And Midwifery Department
City
‌‌‌‌Ahvaz
Province
Khouzestan
Postal code
6135539345
Approval date
2020-05-12, 1399/02/23
Ethics committee reference number
IR.AJUMS.REC.1399.158

Health conditions studied

1

Description of health condition studied
labor pain intensity and duration of labor in primiparous mothers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Intensity of labor pain
Timepoint
At the beginning of the study, dilation 6 cm, 8 cm, 10 cm
Method of measurement
VAZ

2

Description
Duration of labor pain
Timepoint
At the beginning of the study, dilation 6 cm, 8 cm, 10 cm
Method of measurement
Stopwatch

Secondary outcomes

empty

Intervention groups

1

Description
Walking. If the mother is in the walking group, she is asked to walk continuously or intermittently for at least 15 minutes per hour; At the beginning of the study, dilatation of 4 cm, 6 cm, 8 cm, and 10 cm is calculated using a WAZ ruler and McGill Pain Questionnaire and a stopwatch to assess the severity and duration of his pain.
Category
Treatment - Other

2

Description
Birth ball. If the mother is in the birth ball group, she is asked to sit on the ball continuously or intermittently for at least 15 minutes per hour; At the beginning of the study, dilatation of 4 cm, 6 cm, 8 cm, and 1 cm is calculated using the Waz ruler and McGill Pain Questionnaire and his stopwatch pain intensity and duration.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital of Ahvaz
Full name of responsible person
Samira Maleki
Street address
Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3373 8333
Email
sam.maleki69@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3571 5794
Email
sam.maleki69@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Samira Maleki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan Boulevard, Jundishapur University of Medical Sciences, School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3373 8333
Email
sam.maleki69@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid javadifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan Boulevard, Jundishapur University of Medical Sciences, School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3373 8333
Email
nahidjavadifar_341@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Samira Maleki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan Blv, Nursing And Midwifery Department
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3373 8333
Email
sam.maleki69@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Demographic information of individuals and data before and after the intervention are reported without mentioning the name
When the data will become available and for how long
1400
To whom data/document is available
Researchers in the field of medical universities
Under which criteria data/document could be used
Can be used in similar research
From where data/document is obtainable
Researcher personal email
What processes are involved for a request to access data/document
Due to the publication of the article and the registration of the responsible author's information, the applicant will contact the responsible author to receive the data information by academic email, and after confirming the academic email, the information will be sent
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