Protocol summary

Study aim
Determining the impact of a designed educational intervention in pregnant women on the postpartum quality of life
Design
The clinical trial has a control group, with parallel groups, randomized. In order to carry out the intervention, nulliparous women will be divided into two parallel groups by random allocation method using blocked randomization with 6 blocks. For allocation concealment, the names of the control and intervention groups will be written and placed in numbered identical closed and opaque envelopes by a person who has no information about the research objectives.
Settings and conduct
The educational intervention will be held for at least 30 minutes in groups of at least 4 people in the comprehensive health service centers number 1 East of Ahvaz in Ahvaz by the researcher in person. The intervention sessions will start from the age of 28 weeks of pregnancy. Before each meeting, the time and place of the meeting will be reminded. First, participants will complete demographic and SOC-13 questionnaires.
Participants/Inclusion and exclusion criteria
inclusion criteria: Nulliparous women being at gestational age 28 weeks and above being over 18 years old singleton pregnancy ultrasound confirmation of fetus health willingness to participate in the study Exclusion criteria: Women with a history of infertility pregnancy following ART refusing to complete questionnaires cannot be accessed for unpredictable reasons
Intervention groups
Intervention group: The educational content is prepared based on the determinants effective in improving the quality of life after childbirth in primiparous women, which will be obtained from the qualitative and review phase. control group: Participants in the control group will attend routine childbirth preparation classes.
Main outcome variables
SOC, maternal self-efficacy, postpartum quality of life, breastfeeding self-efficacy, type of delivery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230626058592N1
Registration date: 2023-07-05, 1402/04/14
Registration timing: prospective

Last update: 2023-07-05, 1402/04/14
Update count: 0
Registration date
2023-07-05, 1402/04/14
Registrant information
Name
Maryam shami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
shami.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing, implementation and evaluating an educational program to improve the postpartum quality of life among nulliparous women based on Salutogenesis theory: An exploratory sequential mixed methods study
Public title
Salutogenesis theory on the postpartum quality of life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Nulliparous women Being at gestational age 28 weeks and above Being over 18 years old Singleton pregnancy Ultrasound confirmation of fetus health Having no history of depression or long-term medical illness in the past according to the mother's statement Willingness to participation the study
Exclusion criteria:
Women with a history of infertility Pregnancy following assisted reproductive treatment. Refusing to complete questionnaires Cannot be accessed for unpredictable reasons. The presence of illness in the spouse
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
First, a list of nulliparous women who met the inclusion criteria will be extracted from all health centers of Ahvaz. The selected women will be contacted through their contact information to be informed briefly about the purpose and method of the research and then invited to participate in the study. Sampling will continue until the predetermined number of participants enter the study. In order to carry out the intervention, nulliparous women will be divided into two parallel group of intervention group (ST based training program along with routine childbirth preparation classes) and control (routine childbirth preparation classes) by random allocation method using blocked randomization with blocks of 6. For allocation concealment, the names of the control and intervention groups will be written and placed in numbered identical closed and opaque envelopes by a person who has no information about the research objectives and when choosing the envelopes, a person who was not involved in the study is asked to choose an envelope.
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
Research Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ground floor, Ahvaz Academic City
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2023-06-03, 1402/03/13
Ethics committee reference number
IR.AJUMS.REC.1402.137

Health conditions studied

1

Description of health condition studied
Postpartum quality of life
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Postpartum quality of life
Timepoint
Immediately after delivery, 4 weeks after delivery and 8 weeks after delivery
Method of measurement
Using the postpartum quality of life questionnaire

2

Description
Type of delivery
Timepoint
After delivery
Method of measurement
Examination of maternity records

Secondary outcomes

1

Description
Sense of coherence
Timepoint
Before the intervention, immediately after delivery, 4 weeks after delivery and 8 weeks after delivery
Method of measurement
SOC-13 questionnaire

2

Description
Maternal self-efficacy
Timepoint
Immediately after delivery, 4 weeks after delivery and 8 weeks after delivery
Method of measurement
Maternal self-efficacy questionnaire

3

Description
Breastfeeding self-efficacy
Timepoint
Immediately after delivery, 4 weeks after delivery and 8 weeks after delivery
Method of measurement
Breastfeeding Self‑Efficacy Scale‑Short Form

Intervention groups

1

Description
Intervention group: The educational content is prepared based on the determinants effective in improving the quality of life after childbirth in primiparous women, which will be obtained from the qualitative and review phase.
Category
Behavior

2

Description
Control group: Participants in the control group will attend routine childbirth preparation classes.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Center No. 1 in East Ahvaz
Full name of responsible person
Maryam Shami
Street address
Between Rostagari and Vakili, In front of Hoda Middle School, Shahid Gandami St.
City
Ahvaz
Province
Khouzestan
Postal code
6173663369
Phone
+98 919 954 9600
Email
maryamshami1870@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakirkish
Street address
Ground floor, Vice-Chancellor for Research and Technology, Jundishapur University of Medical Sciences and Healthcare Services, Ahvaz, Ahvaz Academic City
City
Ahvaz
Province
Khouzestan
Postal code
61357-15749
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
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
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
Maryam Shami
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Kolahdoz St, Koi Saidieh
City
Zanjan
Province
Zanjan
Postal code
4519783597
Phone
+98 919 954 9600
Email
maryamshami1870@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Shami
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Kolahdoz St, Koi Saidieh
City
Zanjan
Province
Zanjan
Postal code
4519783597
Phone
+98 919 954 9600
Email
maryamshami1870@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Shami
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Kolahdoz St, Koi Saidieh
City
Zanjan
Province
Zanjan
Postal code
4519783597
Phone
+98 919 954 9600
Email
maryamshami1870@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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The demographic characteristics of participants are confidential, but information on other variables will be shareable.
When the data will become available and for how long
12 months after the publication of the final article
To whom data/document is available
Researchers in scientific and academic institutions, health education and health promotion unit of the Ministry of Health and family health unit of the Ministry of Health
Under which criteria data/document could be used
Educational and research use is permitted with the permission of the Ethics Committee of Ahvaz University of Medical Sciences. The application should be sent through the Research Vice-Chancellor of Medical Sciences Universities.
From where data/document is obtainable
Corresponding author: Mojgan Javadnoori javadnoori-m@ajums.ac.ir
What processes are involved for a request to access data/document
Up to three weeks after receiving the request by email to the corresponding author
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