investigating effect of tele midwifery on fear of childbirth, self-efficacy in coping with childbirth and delivery mode in primparous women
Design
Randomized clinical trial with two groups; intervention and control on 70 pregnant women;. Sampling will be conducted by block design (with block size of 4) random allocation.
Settings and conduct
Prenatal clinic of Baharloo Hospital
Participants/Inclusion and exclusion criteria
Score ≥ 38 on the fear of childbirth؛ Nuli parity؛ Age 18 to 35 years old؛ Singleton pregnancy؛ Women in third trimester of pregnancy؛ Minimum literacy
؛ Internet access؛ Without history of psychological disorders؛ Without history of using psychoactive drugs
Intervention groups
The intervention group received tele-midwifery application and received daily content in the form of movies, pictures, music and text. Also, they can talk and ask question about their fears and misconceptions about childbirth through this software. Then they fill out fear of childbirth and self-efficacy questionnaire at 36-38 weeks, also the fear of childbirth score will be measured again in the first two hours after delivery. And the type of delivery recorded and compared with the case group. The control group receives routine care, then they re-fill fear of childbirth and self-efficacy questionnaire at 36-38 weeks, and the fear of childbirth score will be measured again in the first two hours after delivery. And the type of delivery recorded and compared with the control group
Main outcome variables
Fear of Childbirth؛ Self-efficacy؛ mood of Delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200122046227N1
Registration date:2020-01-27, 1398/11/07
Registration timing:prospective
Last update:2020-01-27, 1398/11/07
Update count:0
Registration date
2020-01-27, 1398/11/07
Registrant information
Name
Sahar Khademi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4409 5693
Email address
sahar.khademi975@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-01, 1398/11/12
Expected recruitment end date
2020-05-01, 1399/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Tele-midwifery on fear of childbirth, self-efficacy in coping with childbirth and delivery mode in primparous women
Public title
The effect of tele-midwifery on fear of childbirth, self-efficacy in coping with childbirth and delivery mode
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Score ≥ 38 on the fear of childbirth
Nuli parity
Age 18 to 35 years old
Singleton pregnancy
Women in third trimester of pregnancy
Minimum literacy
Internet access
Without history of psychological disorders
Without history of using psychoactive drugs
Exclusion criteria:
Indications of cesarean section such as abnormal fetal presentation, pelvic stenosis,fetal macrosomia, placenta previa
Having chronic illness before or during pregnancy
Pregnancy disorders (e.g: Placental abruption, abnormal presentation, Preeclampsia,etc. )
Without tendency of participants to follow research
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
This would be done by 4 block randomization. For this purpose firstly,The intervention group is assigned the letter A and the control group is letter B. The 6 possible modes would be written on separate cards and assigned to each card a number (from one to six), The numbers will then be randomly selected using a software, until the expected sample number is completed. Allocation concealment will be carried out using envelopes in a package such that one of the letters is placed in one envelope due to what was determined before, then envelope would be closed and provided to the researcher. The process of random allocation and concealment is performed by the statistical consultant.
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, 16Azar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
IR.TUMS.FNM.REC.1398.135
Health conditions studied
1
Description of health condition studied
Fear of childbirth
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Fear of childbirth
Timepoint
Before intervention, 36-38 weeks of pregnancy, during 2 hours after birth
Method of measurement
Wijma Questionnaire (Version A,B)
2
Description
self-efficacy in coping with child birth
Timepoint
Before intervention, 36-38 weeks of pregnancy
Method of measurement
self-efficacy in coping with child birth questionnaire
3
Description
Delivery mood
Timepoint
After childbirth
Method of measurement
Delivery mood
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group received tele-midwifery application and received daily content in the form of movies, pictures, music and text. Also, they can talk and ask question about their fears and misconceptions about childbirth through this software. Then they fill out fear of childbirth and self-efficacy questionnaire at 36-38 weeks, also the fear of childbirth score will be measured again in the first two hours after delivery. And the type of delivery recorded and compared with the case group.
Category
Other
2
Description
The control group receives routine care, then they re-fill fear of childbirth and self-efficacy questionnaire at 36-38 weeks, and the fear of childbirth score will be measured again in the first two hours after delivery. And the type of delivery recorded and compared with the control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo hospital
Full name of responsible person
Sahar Khademi
Street address
Tehran Province, Tehran, Behdari St, Baharloo hospital
City
Tehran
Province
Tehran
Postal code
1339973111
Phone
+98 21 5565 8500
Fax
+98 21 5564 8189
Email
hosp-baharloo@tums.ac.ir
Web page address
http://baharloo.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sahraian, the Vice Chancellor of Research at Tehran University of Medicine Sciences
Street address
Qods Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sahar Khademi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
the 4 Floor, Yas 3, Yas complex, Behnam 8th street, Ayatollah Kashani street