Comparative effect of peer-based education using mobile phone and face-to-face education on fear of childbirth in primigravia women in comprehensive health centers
Comparison of the effect of peer education based on mobile phone use and face to face training on fear of childbirth in the first pregnant women referred to Meshginshahr comprehensive health centers
Design
Experimental trial with three groups, control group, face-to-face training and mobile phone training by peers on the first 60 pregnant women 24-34 weeks, SPSS 16 software is used to evaluate the results.
Settings and conduct
First pregnant women 24-34 weeks referring to comprehensive health centers who have obtained a score of 80-100 in the fear of childbirth in the questionnaire of fear of childbirth are included in the study. Individuals are divided into three groups: one control group and two intervention groups 1 and 2. The results will be evaluated immediately after the intervention and one month later. The control group receives only routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Literacy of Persian, age range 18 to 35 years
Being pregnant first,
Gestational age 24 to 32 weeks
No stressful events in the last 6 months
Lack of medical indication for cesarean section
No underlying mental illness
Having a mobile phone, internet connection, ability to use WhatsApp application.
Earn a score of 85 and above on the Fear of Childbirth Questionnaire
Exclusion criteria
Increased disease in pregnancy
Any complication in pregnancy such as high blood pressure during pregnancy, premature rupture of the bladder, premature birth
Lack of contact information
Mental illness
Intervention groups
Intervention group 1 receives six 90-minute face-to-face training sessions in health centers
Intervention group 2 receives six 90-minute training sessions through WhatsApp
The control group receiving routine pregnancy care
Main outcome variables
Fear of childbirth
Pregnancy anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200404046943N1
Registration date:2020-09-09, 1399/06/19
Registration timing:retrospective
Last update:2020-09-09, 1399/06/19
Update count:0
Registration date
2020-09-09, 1399/06/19
Registrant information
Name
Fereshta Rostame
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3252 8948
Email address
za.sa.rostame@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of peer-based education using mobile phone and face-to-face education on fear of childbirth in primigravia women in comprehensive health centers
Public title
Comparison of face-to-face training and mobile phone training on fear of childbirth
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Reading and writing Persian literacy
Age range 18 to 35 years
Singleton
primigravia women
Pregnancy age 24 to 32 weeks
No history of infertility
Lack of stressful events in the last 6 months
Lack of medical indications for cesarean section
Lack of mental illness
Having a mobile phone with Android operating system, the ability to connect to the Internet, the ability to use WhatsApp
Get a score of 85 or higher on the Vijma Questionnaire
Exclusion criteria:
Any disease added to the pregnancy that requires a cesarean section for the mother
Having any complications during pregnancy such as high blood pressure during pregnancy, decompression, fetal death, premature rupture of the bladder, preterm delivery
Mental illness
No contact information
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In the study groups, Random allocation will be made with blocking methods. First, all possible combinations of AABBCC blocks will be listed, one code will assign to each of them, and then 11 codes will be select randomly. They will be Blind to ensure that there is no bias. After selecting them, go to the blocks corresponding to each code, and then according to the available combinations, people will enter the study groups.
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 of Urmia University of Medical Sciences
Street address
Khayyam Street
City
Meshginshahr
Province
Ardabil
Postal code
5661844518
Approval date
2020-03-17, 1398/12/27
Ethics committee reference number
IR.UMSU.REC.1399.018
Health conditions studied
1
Description of health condition studied
Fear of childbirth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Childbirth Fear Score in the Vijma Birth Fear Questionnaire
Timepoint
Pre-test (before the start of the intervention), post-test (immediately after the intervention), follow-up (one month after the intervention)
Method of measurement
General score obtained from the Vijma A Fear of Childbirth Questionnaire
2
Description
Pregnancy Anxiety Score in Shortened Questionnaire Pregnancy Anxiety Wendenberg
Timepoint
Pre-test (before the start of the intervention), post-test (immediately after the intervention), follow-up (one month after the intervention)
Method of measurement
The total score obtained from the abbreviated questionnaire of Wendenberg
Secondary outcomes
1
Description
Fear of childbirth
Timepoint
Follow-up test (one month after the last intervention session)
Method of measurement
The overall score obtained from the Vijma Birth Fear Questionnaire
2
Description
Pregnancy Anxiety
Timepoint
Follow-up test (one month after the last intervention session)
Method of measurement
The overall score obtained in the shortened Wondenberg Pregnancy Anxiety Questionnaire
Intervention groups
1
Description
Intervention group 1: Face to face training: 6 training sessions held once a week, and the time of face-to-face training will be 90 minutes. The first sessions Content is Introducing peers and getting acquainted with each other, educating clients about the reproductive system and reproduction of women and the names and functions of some organs involved in childbirth, common complaints during pregnancy, and how to deal with them. Stretching exercises, summarizing the first session and Assignment, and get feedback (feedback on mobile education will be self-reported by mothers). The second session's content is a group discussion on anxiety and stress-related to pregnancy and ways to deal with it, including relaxation methods and breathing techniques, the importance of prenatal care, danger symptoms, personal health, final summary, and assigning feedback. The third session's content is a Review of homework, and a brief review of the previous session, self-control of emotions, nutrition and maintenance of a proper diet, childbirth and pain relief methods, gaining the support of a spouse or a loved one, final summary, Assignment, and provide feedback. The fourth session's content is a Review of homework and a brief review of the previous session, training to introduce common mental errors in childbirth, the importance of vaginal delivery, final summary, homework assignment, and feedback. The fifth sessions Content is a Review of homework and a brief review of the previous session, description of labor stages, labor and delivery process, familiarity with hospital routine, application of distracting behavioral techniques, deep breathing, muscle relaxation, expression of peer experiences of labor and labor stages, summary, Assignment and provides feedback. The sixth session's content is a review of homework and a brief review of the previous session. It teaches people how to use methods to reduce pain and stretch and to breathing exercises to people, teaching breastfeeding, and caring for the baby.
Category
Other
2
Description
Intervention group2: Intervention group via mobile phone Educational content in WhatsApp program in 4 groups of 6-5 people through group chat, sending an audio file and educational video by peers to mothers and questions and answers with group members and discussing training presentations Based on the experience of delivery, the counterparts will be presented. The sessions will be weekly for 90 minutes.
Category
Other
3
Description
Control group،The routine care will receive to the control group during pregnancy, and no intervention will accrue.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Meshginshahr city health center
Full name of responsible person
Hossein Sharifi
Street address
Azadi Square
City
Meshginshahr
Province
Ardabil
Postal code
5661967595
Phone
+98 45 3252 4515
Email
Meshghinhc@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Urmia University of Medical Sciences,Resalat Boulevard,Urmia City,West Azerbaijan Province,Iran
City
Orumieh
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Fax
+98 44 3224 0642
Email
Irajmohebbi@umsu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Fereshteh Rostami
Position
Master's degree student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
The first floor of Sadra building, sub-street 1, Khayyam street, Meshginshahr city, Ardabil province, Iran
City
Meshginshahr
Province
Ardabil
Postal code
5661844518
Phone
+98 45 3252 8948
Email
Za.sa.rostame@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Roqia Bayrami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Nazloo Campus,Urmia University of Medical Sciences,UrmiaWest Azerbaijan Province,Iran
City
Orumieh
Province
West Azarbaijan
Postal code
5756115111
Phone
0098 44327549614
Email
rozabayrami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Fereshteh Rostami
Position
Master's degree student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
The first floor of Sadra building, sub-street 1, Khayyam street, Meshginshahr city, Ardabil province, Iran
City
Meshginshahr
Province
Ardabil
Postal code
5661844518
Phone
+98 45 3252 8948
Email
Za.sa.rostame@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