Determine the effect of peer education in pregnant women on the degree of fear of pain and normal delivery
Design
Clinical trial with intervention and control group, with parallel groups, randomized, randomized
Settings and conduct
The training of mothers in health centers was done in the intervention group of the trained mothers by trained counterparts, the mothers were not informed about which group they were assigned to.
Participants/Inclusion and exclusion criteria
Willingness to cooperate
- Reading and Writing Persian
- Age range 18 to 35 years
- Gestational age 24-34 weeks
- primipara
- Single pregnancy
- Having no physical, mental or psychological illness
- Possibility of direct contact with the pregnant mother
- Lack of participation or incomplete participation in peer education training sessions
- Incidence of any pregnancy complications
- Experience of social and family crises during study
Intervention groups
Patients in the intervention group were trained by their trained counterparts during the four sessions, but the control group received only routine training for pregnant mothers.
All patients in both groups will receive routine training, and no illness will be deprived of relevant training. The intervention in this study has been trained by peers.
Main outcome variables
Reduce fear of normal delivery; reduce labor pain; increase normal delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180320039132N1
Registration date:2018-07-03, 1397/04/12
Registration timing:registered_while_recruiting
Last update:2018-07-03, 1397/04/12
Update count:0
Registration date
2018-07-03, 1397/04/12
Registrant information
Name
Islamic Republic of Iran Yaghoobi Moghadam Bilondi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 9025
Email address
yaghoobi.f@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-13, 1396/12/22
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peer education in pregnant women on the degree of fear of pain and normal delivery
Public title
The effect of peer education on the fear and pain of labor
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate
Having literacy in reading and writing Persian
Age range 18 to 35 years old
Gestational age 24-34 weeks
Primi para
Single pregnancy
Having no physical, mental, or mental illness in accordance with the mother
The lack of medical indication for cesarean section
Possibility to make direct contact with the pregnant mother
Exclusion criteria:
Failure of the company or incomplete company in the peer group training sessions
The onset of any complications of pregnancy (such as preeclampsia, bleeding, diabetes, intrauterine death, early delivery, etc.)
Experience of social and family crises during study
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the names of pregnant mothers with contraceptive control in the centers of health who have the characteristics of the company in the research were extracted and using the random numbers table,n samples were selected and then placed in the control and case groups in a random manner.
Blinding (investigator's opinion)
Single blinded
Blinding description
The mothers are not aware of they are in which group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethnical Committee of Gonabad University of Medical Sciences
Street address
Asian Road Border - University of Medical Sciences
City
Gonabad
Postal code
9691793718
Approval date
2018-05-14, 1397/02/24
Ethics committee reference number
IR.GMU.REC.1397.007
Health conditions studied
1
Description of health condition studied
Fear and pain of normal labor
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fear of giving birth is measured by Vijimy's A fears of delivery.
Timepoint
Before intervention and after intervention
Method of measurement
Vijimy's A fears of delivery.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the case group were trained by peers who were trained during the four-week round.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Gonabad city
Full name of responsible person
Fatemeh Yaghoubi
Street address
Asian Road, University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
f.yaghoobi.m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Reza Esmaili
Street address
Khorasan Razavi - Gonabad - Asian Road Rim - Medical Sciences University - Social Development and Health Promotion Research Center
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Roghayeh Rahmani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Khorasan Razavi - Gonabad - Asian Road Rim - Medical Sciences University - Social Development and Health Promotion Research Center
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3028
Email
roghaiehrahmani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Roghani Rahmani
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Khorasan Razavi - Gonabad - Asian Road Rim - Medical Sciences University - Social Development and Health Promotion Research Center
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3028
Email
roghaiehrahmani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Roghaieh rahmani
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Khorasan Razavi - Gonabad - Asian Road Rim - Medical Sciences University - Social Development and Health Promotion Research Center
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3028
Email
roghaiehrahmani@yahoo.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