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Comparison of the effects of online and in person child birth classes and routine care group on labor pain and pre and postnatal pelvic floor dysfunctions: a three-arm single-blinded controlled clinical trial

Protocol summary

Study aim
Comparison of the effects of online and in person child birth classes and routine care group on labor pain and pre and postnatal pelvic floor dysfunctions
Design
online childbirth classes /in person childbirth classes /control group : mothers do not participate in any of these classes .a three-arm single-blinded controlled clinical trial /this is a non-randomized study
Settings and conduct
This study is conducted on pregnant mothers who are in the 20th or 21st week of pregnancy and are eligible to enter. The classes are held in Al-Zahra Hospital and Valiasr Hospital in Tabriz. According to their wishes and conditions, pregnant mothers are placed in one of the three study groups (in-person class and no class).
Participants/Inclusion and exclusion criteria
Including criteria : Being a primiparous , having a single child, 20 weeks gestation, age between 18 and 42, having full control of urine, stool and gas, willingness to participate in the study, ability to fully understand the instructions .Excluding criteria : Having a heart, brain, respiratory disease, having incontinence, pelvic floor disorder, history of abortion and premature birth, diabetes, high blood pressure, previous birth, multiple births, drug and smoking addiction, absenteeism and non-participation in class. over the limit (more than 2 sessions)
Intervention groups
In the first group, childbirth preparation classes are held by a pelvic floor physiotherapist virtually and online for pregnant mothers.In the second group, childbirth preparation classes are held by pelvic floor physiotherapists, in person at Al-Zahra and Valiasr hospitals.In the control group, pregnant mothers do not participate in any of the classes.
Main outcome variables
pelvic floor dysfunctions labor pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140811018760N10
Registration date: 2024-09-14, 1403/06/24
Registration timing: registered_while_recruiting

Last update: 2024-09-14, 1403/06/24
Update count: 0
Registration date
2024-09-14, 1403/06/24
Registrant information
Name
Fariba Ghaderi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 4647
Email address
ghaderif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-07, 1403/06/17
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of online and in person child birth classes and routine care group on labor pain and pre and postnatal pelvic floor dysfunctions: a three-arm single-blinded controlled clinical trial
Public title
Comparison of the effects of online and in person child birth classes and routine care group on labor pain and pre and postnatal pelvic floor dysfunctions: a three-arm single-blinded controlled clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women who are in the 20th or 21st week of pregnancy and have visited Al-Zahra educational-therapeutic center or Vali-Asr hospital.
Exclusion criteria:
Having heart diseases, brain diseases , respiratory diseases, having incontinence, having pelvic floor disorders, having a history of abortion and premature birth, diabetes, high blood pressure, previous birth, multiple births, drug and smoking addiction, absenteeism and non-participation in class. over the limit (more than 2 sessions)
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessment procedure will be done by a trained midwife which are not informed about the grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
school of rehabilitation, Daneshgah Ave., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Approval date
2024-07-08, 1403/04/18
Ethics committee reference number
IR.TBZMED.REC.1403.277

Health conditions studied

1

Description of health condition studied
Pregnancy
ICD-10 code
Z34
ICD-10 code description
Encounter for supervision of normal pregnancy

Primary outcomes

1

Description
pelvic floor dysfunction pre and postnatal
Timepoint
at the beginning of study , last week of pregnancy and three month postpartum
Method of measurement
PFDI-20 questionnaire

2

Description
labor pain
Timepoint
immediately after childbirth
Method of measurement
Visual Analogue Scale (VAS)

Secondary outcomes

1

Description
Childbirth satisfaction
Timepoint
Immediately after childbirth
Method of measurement
Mackey Satisfaction Rating Scale=MCSRS

2

Description
Satisfaction with the Childbirth Education Class
Timepoint
At the last week of pregnancy
Method of measurement
Satisfaction with the Childbirth Education Class Questionnaire

3

Description
Exercise adherence
Timepoint
At the last week of pregnancy
Method of measurement
Exercise Adherence Rating Scale

Intervention groups

1

Description
Intervention group: Online childbirth education with pelvic floor physical therapist
Category
Prevention

2

Description
Intervention group: In person childbirth education with pelvic floor physical therapist
Category
Prevention

3

Description
Control group: Mothers who do not participate in any childbirth classes
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra medical education center
Full name of responsible person
Fariba Ghaderi
Street address
Al- Zahra medical education center, south Artesh street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3334 5121
Fax
+98 41 3334 5121
Email
ghaderif@tbzmed.ac.ir

2

Recruitment center
Name of recruitment center
Vali-asr Hospital
Full name of responsible person
Fariba Ghaderi
Street address
The beginning of Zafaranieh - Vali-asr Hospital, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
۱۴۴۶۹۳۳۷۱۴۰
Phone
+98 41 3332 1736
Email
ghaderif@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Street address
Central Building of University of Medical Sciences, Golgasht St., Azadi St., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 2072
Email
rehab.fac@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fariba Ghaderi
Position
Assistant Professor- PhD of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences ,Rehabilitation faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 413339771
Fax
Email
ghaderif@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 1333 4647
Fax
+98 41 1333 4647
Email
ghaderif@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 1333 4647
Fax
+98 41 1333 4647
Email
ghaderif@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
A decision will be made for publication after the completion of the plan
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
Undecided - It is not yet known if there will be 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
The study protocol and clinical study report will be published in reputable journals
When the data will become available and for how long
After completing sampling and data analysis
To whom data/document is available
A decision will be made based on the policy of the desired magazine
Under which criteria data/document could be used
Use of other researchers and health policy
From where data/document is obtainable
Responsible and executor of the plan
What processes are involved for a request to access data/document
Send to the project manager
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