Determining the effectiveness of midwifery counseling in the form of "supportive group therapy" on fear of childbirth, desire for type of delivery and happiness of pregnant women
Design
A one-blind control group clinical trial in which the statistical analyzer did not know the content of the sessions.
Randomized by block method to volume 4. on 90 patients
Settings and conduct
The study site is Kordkoy city in Golestan province.
The study is done according to the corona virtually if the disease is not controlled.
Sessions 5 sessions are managed with the help of the leader who is the executor of the project and the help of the leader who is a midwife with experience. 9 people participate in each session.
Due to the nature of the study, it is not possible to be blind, but the statistical analyst but the person completing the questionnaire is not aware of the group of people.
Participants/Inclusion and exclusion criteria
• Preference for cesarean delivery or hesitation in choosing the type of delivery
• First pregnancy and twin pregnancy
• Being 18 to 35 years old
• Minimum literacy
Gestational age 22 to 30 weeks
• Healthy and normal fetus in the first trimester ultrasound examinations
• Having computer information (if the class is held virtually)
Conditions of non-entry: smoking, alcohol and drugs. Having a history of recurrent miscarriage and infertility and neurological and psychological disorders
Intervention groups
Supportive group therapy is considered, which will be done in 5 sessions with the participation of pregnant women and the guidance of the leader and the help of the leadership. Questionnaires will be completed in the control and intervention group, and offline classes will also be held.
Main outcome variables
Fear of childbirth; The desire for the type of delivery; Happiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201209049657N1
Registration date:2021-01-29, 1399/11/10
Registration timing:registered_while_recruiting
Last update:2021-01-29, 1399/11/10
Update count:0
Registration date
2021-01-29, 1399/11/10
Registrant information
Name
Zahra Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3434 7488
Email address
seyedezahramousavi87311@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-16, 1399/10/27
Expected recruitment end date
2021-08-20, 1400/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of midwifery " Supportive group therapy " on fear of delivery, Tendency to type of delivery and happiness in pregnant women
Public title
Evaluation of the effectiveness of supportive group therapy on fear of childbirth, tendency to type of childbirth and happiness of pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Prefer cesarean delivery or be hesitant about choosing the type of delivery.
Be the first and single pregnancy
No history of recurrent miscarriage.
Be at least literate.
Her gestational age at the beginning of the study should be 22-30.
The fetus is healthy and normal in the first trimester ultrasound examinations.
Have computer information if the class is held virtually
There are no obvious and recognizable barriers to normal delivery at the time of sampling.
Exclusion criteria:
Have an addiction to alcohol, cigarettes and drugs.
Have a history of recurrent miscarriage or infertility.
Have a neurology and psychiatry Disorder
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Using the allocation sequence that was produced based on the block method to volume 4. First, the city is divided into three regions in terms of socio-economic, then one center is selected at random from each region, and people are selected at random from each center.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the study, it is not possible to blind the participants.
However, the data collector (person completing the questionnaire) will not be aware of the group of people. Thus, pre-intervention questionnaires are administered before random assignment of individuals to groups. After the intervention, the data collector is not aware of the group of people. The statistical analyzer will also be unaware of the group of people.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
12th flower alley, Pasdaran street
City
Kordkuy
Province
Golestan
Postal code
4881878879
Approval date
2020-12-07, 1399/09/17
Ethics committee reference number
IR.SHMU.REC.1399.130
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
2
Description of health condition studied
ICD-10 code
ICD-10 code description
3
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fear of childbirth
Timepoint
This variable will be measured before the start of the study and after the intervention.
Method of measurement
Vijma Maternity Fear Questionnaire
2
Description
Tendency to type of delivery
Timepoint
This variable will be measured before the start of the study and after the intervention.
Method of measurement
By asking pregnant women about their desire for childbirth
3
Description
happiness
Timepoint
This variable will be measured before the start of the study and after the intervention.
Method of measurement
Through the Oxford Happiness Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
My intervention group consists of 5 groups of nine people who, in addition to participating in supportive therapy groups, also participate in offline training classes that are matched with the control group and complete a questionnaire. Supportive group therapy will be performed in 5 one-hour sessions per week for the intervention group. The group leader is the project manager himself, who is a graduate student in midwifery counseling, and the assistant midwife treatment partner has experience in natural childbirth. If a session is held to discuss unspecified topics, a session will be added to it. .) And Introducing the treatment method Session 2: Discussion and education about the benefits and complications of natural childbirth Session 3: Discussion and education about the complications of cesarean delivery Session 4: Skills training and stress management Muscle relaxation) Session 5: Reviewing the previous sessions, summarizing, completing the questionnaire. Will be asked before and after the intervention.
Category
Treatment - Other
2
Description
The control group consists of 5 groups of 9 people. Before the intervention and after the intervention, they will fill out the Vijma and Oxford Maternity Fear Questionnaire and will be asked about the desire for the type of delivery before participating in the research and after participating in the research. They will also participate in offline training classes.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan University of Medical Sciences, Health centers of Kordkoy city in Golestan province
Full name of responsible person
Dr. Arash Naghipour
Street address
in front of Telecommunication, Vali Asr Street
City
Kordkuy
Province
Golestan
Postal code
4881787789
Phone
+98 17 3434 3627
Fax
+98 17 3434 5174
Email
seyedezahramousavi87311@gmail.com
Web page address
http://www.goums.ac.ir/index.php?sid=45
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Emamian Mohammad Hasan
Street address
Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
info@shmu.ac.ir
Web page address
https://www.shmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Zahra Mousavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Alley Gol12, Pasdaran St
City
Kordkoy
Province
Golestan
Postal code
4881878879
Phone
+98 17 3434 7488
Email
Seyedezahramousavi87311@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Seyedezahra Mousavi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gol Alley 12, Pasdaran Street.
City
Kordkoy
Province
Golestan
Postal code
4881878879
Phone
+98 17 3434 7488
Email
Seyedezahramousavi87311@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Zahra Mousavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gol 12 Alley, Pasdaran St.
City
Kordkoy
Province
Golestan
Postal code
4881878879
Phone
+98 17 3434 7488
Email
Seyedezahramousavi87311@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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data of each questionnaire and interviews with individuals who are not known due to blindness belong to whom.
However, the data can be published if it is clear that it belongs to the intervention group or the control. Data related to the main outcome, etc. can also be published .In fact, all the data that we have, including questionnaires, etc., can be published.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The project data and documentation can be used by researchers working in academic and scientific institutions, as well as people working in health centers and hospitals and management systems and private offices.
Under which criteria data/document could be used
The documentary can be used for further research and development of science in this field or for work in a private office, etc.
From where data/document is obtainable
To receive data and documents, contact Ms. Seyedeh Zahra Mousavi, the project manager, at the email address Seyedezahramousavi87311@gmail.com and the mobile number 09112788820 and the postal address of 12th Gol Alley, Pasdaran St, Golestan province and postal code 4881878879.
What processes are involved for a request to access data/document
The request for data will be provided to the applicant immediately upon observation by the developer.