Set the effect of midwifery led counseling based on gamble's Approach on childbirth fear and self-efficacy in nulligravida women
Compare the type of preferential maternity pregnant women between the experimental and control group before and after intervention
Design
The statistical society of present research will be all nulligravida women who referred to health and treatment centers of Zanjan city in 2018. The sampling method of this research will be in random cluster way in two stages from all health and treatment centers of Zanjan city. In a way that all these centers are being categorized in three social conditions of weak, average and good districts. Then, from each district`s health and treatment centers, two of them will be selected randomly. From 80 women with high childbirth fear rate, 40 women are going to be selected in block randomized method as research`s control and experimental groups.
Settings and conduct
Health centers of Zanjan city. Facial and phone call consulting sessions for experimental group during 24 and 34 weeks of pregnancy.
The questionnaires will be completed in 36 week of pregnancy in both groups by another researchers help who is unaware of group`s sampling method. The person who will analyze the data have no information about the experimental and control groups.
Participants/Inclusion and exclusion criteria
Nulligravida, Earning the score of 66 or more from Wijma`s childbirth fear questionnaire
Intervention groups
The researcher will present a consult session with pregnant women during 24 to 34 weeks of pregnancy. In addition, during these weeks (24 to 34), each week one consultancy session will be held through phone calls. The control group will receive standardized cares.
Main outcome variables
Reduce the fear of childbirth; Enhance self-efficacy for pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101219005417N3
Registration date:2018-12-19, 1397/09/28
Registration timing:retrospective
Last update:2018-12-19, 1397/09/28
Update count:0
Registration date
2018-12-19, 1397/09/28
Registrant information
Name
Elham Jafari
Name of organization / entity
Zanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 72725130241
Email address
ejafari@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of midwifery led counseling based on gamble's Approach on childbirth fear and self-efficacy in nulligravida women
Public title
The effect of midwifery led counseling on childbirth fear and self-efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-35 years old
The first pregnancy
Monogamous fetus
There is no history of infertility
Not having a history of chronic illness, medical or obstetrical
The lack of a history of mental health disorders and taking psychedelic drugs
The desire to participate in the study
Having at least cycle education
Earning a score equal to or higher than 66 wijma fear questionnaire
Earning a score of less than or equal to the 51 of Toronto's questionnaire
The current mental health score the mother include lack of depression less or equal to 13; anxiety score less than or equal 9; lack of stress less than or equal to 18
Exclusion criteria:
Fetal death before birth in the domain of research time
Ultrasound of the abnormal embryo
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
in this research the groups are selected in block randomized method into two experimental and control groups (each group will contain 40 members). In a way that at first 6 block may put together according to group`s layout and will be identified and numbered in both group A (experimental) and B (control). Then, block`s numbers will be selected through randomized numbers` table until we achieve the sample size. Written testimonial of sample`s cooperation will be received in advance.
Blinding (investigator's opinion)
Double blinded
Blinding description
By employing an expert researcher, who does not have any information about experimental and control groups, we will gather the data in 36 week of pregnancy. Also the data will be analyzed without any information about group selection, .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of medical sciences
Street address
Zanjan University of medical sciences, Central Headquarters, The beginning of the Islamic Republic Blvd., Azadi square
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.ZUMS.REC.1397.025
Health conditions studied
1
Description of health condition studied
The fear of childbirth and self-efficacy for pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
- nulligravida women`s childbirth fear
Timepoint
20-24 weeks of pregnancy (before starting the intervention) and twelve weeks after the start of the intervention
Method of measurement
Wijma fear questionnaire (Version A W-DEQ)
2
Description
nulligravida women`s self- efficacy
Timepoint
Twenty-four weeks of pregnancy (before the start of the intervention) and twelve weeks after the start of the intervention
Method of measurement
The questionnaire and the scale of the expected outcome of the delivery and efficacy of Louie
Secondary outcomes
1
Description
The preferred method of delivery
Timepoint
Twenty four weeks of pregnancy (before the start of the intervention) And thirty-six weeks of pregnancy
Method of measurement
The preferred method of delivery of the questionnaire a question
Intervention groups
1
Description
Control Group: This group will receive their special standard care.
Category
Other
2
Description
Intervention group: Based on Gamble`s approach, two midwifery- based counseling sessions will be presented in 24 and 34 pregnancy weeks and in addition, one phone call consulting session in each week will be held during 24 to 36 weeks of pregnancy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Municipal Health Service Center No. 3
Full name of responsible person
Laya firouzan
Street address
The beginning of north Saadi, Cross road Sadi, Municipal Health Service Center No. 15
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3345 1805
Email
L.firouzan6008@gmail.com
2
Recruitment center
Name of recruitment center
Municipal Health Service Center No. 15
Full name of responsible person
Laya Firouzan
Street address
Yasmine one, Farhang alley, Municipal Health Service Center No. 15
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3353 3660
Email
L.firouzan6008@gmail.com
3
Recruitment center
Name of recruitment center
Municipal Health Service Center No. 11
Full name of responsible person
Laya Firouzan
Street address
Second floor, Next to the gas pump, 45 meters, Golshahr, Municipal Health Service Center No. 11
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 5852 9606
Email
l.firouzan6008@gmail.com
4
Recruitment center
Name of recruitment center
Municipal Health Service Center No. 18
Full name of responsible person
Laya firouzan
Street address
Piece 4142, East Tulue Ave., Phase 3, Kazemeie Golshahr, Municipal Health Service Center No. 18
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3372 7100
Email
l.firouzan6008@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Reza Shogli
Street address
Zanjan University of Medical Sciences Research & Technology Center, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0650
Email
l.firouzan6008@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Laya Firouzan
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan Nursing and Midwifery Faculty, End of Ahmad Mahdavi Ave, KarmandanTownship
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8375
Email
l.firouzan6008@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Laya Firouzan
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan Nursing and Midwifery Faculty, End of Ahmad Mahdavi Ave, KarmandanTownship
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8375
Email
l.firouzan6008@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Laya Firouzan
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan Nursing and Midwifery Faculty, End of Ahmad Mahdavi Ave, KarmandanTownship
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8375
Email
l.firouzan6008@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data is not completed yet.
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