1- Investigation and comparison birth type in control and study group after intervention
2- Investigation and comparison perception of child birth in control and study group after intervention
Design
clinical trial with intervention and control group. a parallel group design of 130 people.
Settings and conduct
clinical trial study with control and intervention group in 4 general health center, Yaftabad, Sina, Saadatabad, Janatabad on 130 pregnant women. intervention group in 32th week of pregnancy receive a peer experience story video and continue 5 weeks. control group receive a nutrition in pregnancy video.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Have minimum 32 gestational age;
Pregnant mother has 18 to 32 years old;
Have ability to read and write;
Accessibility to network for receiving videos;
Excluion criteria:
High-risk pregnancy (for example menorrhagia in pregnancy, gestational; diabetes, preeclampsia, hypertension...);
Addiction in pregnant;
History of infertility;
Contraindication of vaginal birth
Intervention groups
Use peer birth experience story in study group and teaching nutrition videos for control group
Main outcome variables
Perception of childbirth;
Type of delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180427039436N11
Registration date:2021-08-09, 1400/05/18
Registration timing:prospective
Last update:2021-08-09, 1400/05/18
Update count:0
Registration date
2021-08-09, 1400/05/18
Registrant information
Name
Leila Amiri Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1139
Email address
l.amirifarahani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of digital storytelling of peer birth experiences on the type and perception of childbirth in primiparous women
Public title
Investigating the effect of digital storytelling of peer birth experiences on the type and perception of childbirth in primiparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have minimum 32 gestational age
Single fetus pregnancy
Pregnant mother has 18 to 35 years old
Have ability to read and write
Accessibility to network for receiving video
Exclusion criteria:
High-risk pregnancy ( for example menorrhagia in pregnancy, gestational diabetes, preeclampsia, hypertension..)
Addiction in pregnant person
History of infertility
Contraindication of vaginal birth
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Use of peer birth experience in digital videos to effect on perception of child birth in primiparous women
Investigating the effect of digital storytelling of peer birth experiences on the type and perception of childbirth in primiparous women
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
Perception of childbirth
Timepoint
7 to 21 days after delivery
Method of measurement
Perception of childbirth Questionnaire
2
Description
Type of delivery
Timepoint
After delivery
Method of measurement
Telephone question
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Story video During the 32nd to 36th week of pregnancy, a video is sent to the study group on the virtual network (Skype) every week. People in the test group are advised to watch the submitted video at least twice a week. At the end of each week, in a group created, the study group on Skype is asked to share the message received from the video with other women.
Category
N/A
2
Description
Control group: The video of nutrition training during pregnancy, 32 to 36 weeks of pregnancy will be sent to the control group in the virtual network (Skype).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaghayegh Comprehensive Health Service Center
Full name of responsible person
Zahra Mahdavi
Street address
Janatabad Markazi, above Besat Boulevard, Asgari Alley, No. 6, 4th floor, Unit 7
City
Tehran
Province
Tehran
Postal code
1853934179
Phone
+98 21 4604 3796
Email
zahra.mahddavii1997@gmail.com
2
Recruitment center
Name of recruitment center
Saadat Abad Comprehensive Health Service Center
Full name of responsible person
Zahra mahdavi
Street address
The end of 24 meters of Saadat Abad Boulevard, Evin Street, next to the Prisons Cooperative
City
Tehran
Province
Tehran
Postal code
1853934179
Phone
+98 21 2211 5750
Email
zahra.mahddavii1997@gmail.com
3
Recruitment center
Name of recruitment center
Yaftabad Comprehensive Health Service Center
Full name of responsible person
Zahra Mahdavi
Street address
Moallem Square, Al-Ghadir Square, Shahid Zandieh St., Shahid Mostafa Hashemi St., next to Bank Saderat
City
Tehran
Province
Tehran
Postal code
1377717651
Phone
+98 21 6681 3076
Email
zahra.mahddavii1997@gmail.com
4
Recruitment center
Name of recruitment center
Sina Comprehensive Health Service Center
Full name of responsible person
Zahra Mahdavi
Street address
Persian Gulf Street, Beheshti Street, corner of Mehr Alley, No. 12
City
Tehran
Province
Tehran
Postal code
1377717651
Phone
+98 21 6626 4152
Email
zahra.mahddavii1997@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevalian
Street address
Shahid hemat highway, direction2
City
Tehran
Province
Tehran
Postal code
1981111198
Phone
+98 11 3943 6521
Email
L.amirifarahani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Leila amirifarahani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Valiaasr ave, Rashid yasami Ave. infront of Khatamol anbiaa hospital
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 11 3943 6521
Email
L.amirifarahani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila amirifarahani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Valiaasr ave, Rashid yasami Ave, infront of khatamol anbiaa hospital
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 11 3943 6521
Email
L.amirifarahani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila amirifarahani
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Valiaasr ave, Rashid yasami Ave. infront of Khatamol anbiaa hospital
City
tehran
Province
Tehran
Postal code
1996713883
Phone
+98 11 3943 6521
Email
L.amirifarahani@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