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The effect of integration of psycho-educational intervention into childbirth preparation classes by midwives on the level of fear, stress, anxiety, self-efficacy of mothers

Protocol summary

Study aim
Determining the effect of integrating psycho-educational intervention into childbirth preparation classes by midwives on the level of fear, stress, pregnancy anxiety and self-efficacy of mothers.
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, on 110 mothers.
Settings and conduct
Two comprehensive health centers and West and East Ahvaz Health Bases have childbirth preparation classes under the supervision of Ahvaz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria Iranian nationality -Farsi language Gestation age 20-24 weeks Single pregnancy - At least reading and writing literacy - Certificate of introduction to the class from the caregiver (midwife, doctor, gynecologist) - Consent to participate in the research Exit criteria Failure to perform prenatal care - Prohibition to participate in the class in the opinion of a gynecologist or a caring midwife - Presence of obvious fetal abnormalities - Substance abuse and addiction to narcotics and psychotropic drugs and stimulants and drinking alcoholic beverages - Suffering from mental illnesses or facing unfortunate and stressful events within 6 months before the start of the study
Intervention groups
In the control group, childbirth preparation classes with the current content of the Ministry of Health are held from 20 to 37 weeks. In the intervention group, childbirth preparation classes with the content of psychological-educational intervention integration are conducted in all sessions by two trained midwives.
Main outcome variables
Fear of childbirth, stress in pregnancy, pregnancy anxiety, type of childbirth, satisfaction with childbirth, first and fifth minute Apgar of the baby, childbirth self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181214041963N4
Registration date: 2024-03-12, 1402/12/22
Registration timing: prospective

Last update: 2024-03-12, 1402/12/22
Update count: 0
Registration date
2024-03-12, 1402/12/22
Registrant information
Name
Atefeh Ebrahimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3420 0651
Email address
ebrahimiyan127@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-18, 1403/01/30
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of integration of psycho-educational intervention into childbirth preparation classes by midwives on the level of fear, stress, anxiety, self-efficacy of mothers
Public title
The effect of integration of psycho-educational intervention into childbirth preparation classes by midwives on the level of fear, stress, anxiety, self-efficacy of mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality Persian language Gestation age 20-24 weeks singleton pregnancy Literacy for reading and writing Certificate of introduction to the class from the caregiver (midwife, doctor, gynecologist) Consent to participate in research
Exclusion criteria:
Lack of prenatal care Prohibition to participate in the class according to the attending gynecologist or midwife The presence of obvious fetal abnormalities Substance abuse and addiction to drugs and psychotropic drugs and stimulants and drinking alcoholic beverages Suffering from mental illnesses or facing unfortunate and stressful events within 6 months before the start of the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
The research units are randomly divided into one of two groups of childbirth preparation classes with current content and childbirth preparation classes with the integration of psycho-educational intervention by midwives using a computerized random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the intervention, participants could not be blinded. However, the research assistants who will perform the data collection and data analysis will be unaware of the group allocation and also the participants of this study will be blinded to the study hypotheses and will not be aware of their group allocation to the intervention and control group. will be informed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Golestan St., Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2024-02-24, 1402/12/05
Ethics committee reference number
IR.AJUMS.REC.1402.673

Health conditions studied

1

Description of health condition studied
Integration of psycho-educational intervention into childbirth preparation classes by midwives
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fear of childbirth
Timepoint
Version A will be completed before delivery and in the last session of childbirth preparation classes, and version B will be completed two weeks after delivery.
Method of measurement
Vijma fear of childbirth questionnaire version A and B

2

Description
Type of delivery
Timepoint
After studying
Method of measurement
check list

3

Description
Stress from childbirth
Timepoint
After studying
Method of measurement
Pregnancy stress and worry questionnaire

4

Description
Anxiety about childbirth
Timepoint
After studying
Method of measurement
Spielberger overt anxiety questionnaire

5

Description
Mothers' satisfaction with childbirth
Timepoint
After studying
Method of measurement
MacKey childbirth satisfaction questionnaire

6

Description
Childbirth self-efficacy
Timepoint
After studying
Method of measurement
Childbirth self-efficacy questionnaire

7

Description
Apgar of the baby in the first and fifth minutes
Timepoint
After studying
Method of measurement
Baby checklist

Secondary outcomes

1

Description
breastfeeding
Timepoint
After studying
Method of measurement
check list

Intervention groups

1

Description
Intervention group:: The content of psycho-educational intervention in all the sessions of childbirth preparation classes has been developed to provide information related to the childbirth process and reduce stress, anxiety, fear and preparation of pregnant women for childbirth. In the beginning, the psycho-educational content, which was prepared using reliable sources and new articles under the guidance and consultation of a gynecology and obstetrics specialist, 5 members of the academic staff of Ahvaz School of Nursing-Midwifery and 5 midwives working in teaching in Birth preparation classes will be approved. Also, corrections were made according to the opinion of these professors and at the end the final content is used in the research. After the approval, the content of the designed intervention will be printed and a video will be made available. Before the start of the research, two midwives who organize childbirth preparation classes in the intervention group in the centers of East and West Ahvaz will be taught the content of the intervention by the researchers. The content of this intervention was in 8 sessions of 90-minute childbirth preparation classes for the intervention group by two trained midwives in the centers of West and East Ahvaz who work in these centers and the experience of holding childbirth preparation classes in health centers and hospitals. will be implemented.
Category
N/A

2

Description
Control group: In the control group, childbirth preparation classes with the current content of the Ministry of Health are held from 20 to 37 weeks.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Two comprehensive health centers and West and East Ahvaz Health Bases have childbirth preparation
Full name of responsible person
Atefeh Ebrahimian
Street address
Golestan St, Jundi Shapur Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Fax
+98 916 040 5709
Email
ebrahimiyan127@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Street address
Golestan St, Jundi Shapur Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3373 8331
Email
abbaspoor_z762@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
70
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
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 0000
Email
Abbaspoor_z762@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Atefeh Ebrahimian
Position
P.hD student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan St ، Jundi Shapur Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3311 0000
Email
ebrahimiyan127@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Atefeh Ebrahimian
Position
P.hD student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan St, Jundi Shapur Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
ebrahimiyan127@gmail.com

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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