The Effect of Consultation with Empowerment Approach on Pregnancy Anxiety and Self-Efficacy Childbirth
Design
A randomized controlled clinical trial study was performed on 70 women aged 32-28 weeks old who were referred to Tabriz health centers. Contributors through random blocking using RAS software with blocks 4 and 6 will be assigned to the counseling and control groups with a 1: 1 ratio
Settings and conduct
Sampling from 16 selected health centers will be done randomly from among 80 centers of Tabriz. Then, the sampling will be made available from the selected centers. After obtaining written consent, pre-test questionnaires (demographic, Kameda empowerment, Child Birth Self Efficacy: CBSE and Pregnancy Anxiety Pregnancy Anxiety Questionnaire) will be completed by interviewing pregnant women. After 4-8 weeks after intervention, post-test questionnaires (Kameda empowerment, Child Birth Self Efficacy: CBSE and Pregnancy Related Anxiety Questionnaire) will be completed.
Participants/Inclusion and exclusion criteria
Single-swallow pregnancy;Gestational age 28 to 32 weeks;Age of 35-18 years; First pregnancy; Risk of no pregnancy; Average score of less than 62 in the self-efficacy tool ;
Exit criteria: history of cesarean delivery; history of mental illness or current disease; history of participation in labor preparation class; early delivery
Intervention groups
The intervention group, four consultation sessions will be provided once a week for 90 to 120 minutes. The control group will receive only regular pregnancy care.
Main outcome variables
The main outcomes of this study were comparison of the mean of pregnancy anxiety and self-efficacy of labor in two groups of intervention (counseling) and control, before and 4-8 weeks after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171007036615N5
Registration date:2018-11-12, 1397/08/21
Registration timing:registered_while_recruiting
Last update:2018-11-12, 1397/08/21
Update count:0
Registration date
2018-11-12, 1397/08/21
Registrant information
Name
عصمت مهرابی
Name of organization / entity
دانشگاه علوم پزشکی تبریز
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0649
Email address
mehrabie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-11, 1397/06/20
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of empowerment approach counseling on pregnancy anxiety and child birth self efficacy: a Randomized Controlled Clinical Trial
Public title
Effect of empowerment approach counseling on pregnancy anxiety and child birth self efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Single-swallow pregnancy
Gestational age 28 to 32 weeks
Age of 35-18 years
Primiparus
Risk of no pregnancy (no baseline cardiac, pulmonary, thyroid, blood pressure, diabetes and thrombosis, according to a pregnant woman.)
Not having trouble communicating (distance problem, verbal problem, etc.
Average score of less than 62 in the self-efficacy tool
Exclusion criteria:
A history of previous cesarean section
A history of mental illness or current infection as reported by the patient
Participation in Maternity Preparation Classes
Recent maladaptive events that lead to mental and emotional discomfort
Premature labor
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to the control and intervention groups (consultants) using the RAS software by random blocking with the size of blocks 4 and 6 and with a 1: 1 assignment ratio. To hide the allocation, after filling in the questionnaires and having the entry criteria in the order that they are sampled, the type of intervention will be written on a sheet of paper and placed inside the matte and back packed envelopes numbered ( Allocation Concealement). The envelopes will be retrieved by the person not involved in the sampling and analysis of the data
Blinding (investigator's opinion)
Triple blinded
Blinding description
To hide the allocation, after After obtaining informed consent letter, filling in the questionnaires will be completed by having the entry criteria. This is a triple blind study.In the order, the type of study group (intervention or control) will be written on a sheet of paper and placed inside the matte and back packed envelopes numbered ( Allocation Concealment). The envelopes will be retrieved by the person not involved in the sampling and analysis of the data. Data analysis will performed by who not involved in the sampling.
Placebo
Not used
Assignment
Parallel
Other design features
A randomized controlled clinical trial study was performed on 70 unplanned pregnant women referring to Tabriz health centers. Contributors through random blocking using RAS software with blocks 4 and 6 will be assigned to the counseling and control groups with a 1: 1 ratio.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
South Shariati Street; Facuity of Nursing and Miwifery of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2018-09-25, 1397/07/03
Ethics committee reference number
IR.TBZMED.REC. 1397.539
Health conditions studied
1
Description of health condition studied
Pregnancy anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
Primary outcomes
1
Description
Child Birth Self Efficacy
Timepoint
Before entervention ,48-24 hoursafter delivery and 4-8 weeks after invention
Method of measurement
Child Birth Self Efficacy Questionnare
2
Description
Pregnancy anxiety
Timepoint
Before intervention and 4 to 8 weeks after inventio
Method of measurement
Pregnancy Related Anxiety Questionnaire
3
Description
Empowerment Pregnant Women
Timepoint
Before intervention and 4 to 8 weeks after intervention
Method of measurement
KAMEDA Cuestionnaire
Secondary outcomes
1
Description
Epowerment
Timepoint
Before intervention and 4-8 weeks after interwention
Method of measurement
KAMEDA Questionnare
Intervention groups
1
Description
Control group: Control group will only receive routin pregnancy care
Category
N/A
2
Description
In the intervention group, counseling during 4 sessions will be 120-90 minutes in 4 consecutive weeks
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Mojahedin
Full name of responsible person
Masoumeh Adeli
Street address
Mofatteh St -Shahid Imam Doost St
City
Tabriz
Province
East Azarbaijan
Postal code
5145797613
Phone
+98 41 3233 5950
Email
ma.adeli5515@gmail.com
2
Recruitment center
Name of recruitment center
Sayyad Shirazii
Full name of responsible person
Masoumeh Adelli
Street address
Pasdaran St -Oposite Maleki shops
City
Tabriz
Province
East Azarbaijan
Postal code
5147743813
Phone
+98 41 2352 3421
Email
ma.adeli5515@gmail.com
3
Recruitment center
Name of recruitment center
Shahid Babayi
Full name of responsible person
Masoumeh Adeli
Street address
Flight City Parvaz-Opposite The Polis Park
City
Tabriz
Province
East Azarbaijan
Postal code
5167753561
Phone
+98 41 3385 1115
Email
ma.adeli5515@gmail.com
4
Recruitment center
Name of recruitment center
Molla Hasan
Full name of responsible person
Masoumeh Adeli
Street address
Molla Hasan -The End Of Segatoleslam St
City
Tabriz
Province
East Azarbaijan
Postal code
5138984969
Phone
+98 41 3555 5301
Email
ma.adeli5515@gmail.com
5
Recruitment center
Name of recruitment center
Qom Tape
Full name of responsible person
Masoumeh Adeli
Street address
Shahid Garebaghi St- Yeke Dokan
City
Tabriz
Province
East Azarbaijan
Postal code
5146967155
Phone
+98 41 3235 7615
Email
ma.adeli5515@gmail.com
6
Recruitment center
Name of recruitment center
Imamieh
Full name of responsible person
Masoume Adeli
Street address
Mearaj St-Hakim Nezami St
City
Tabriz
Province
East Azarbaijan
Postal code
5164843918
Phone
+98 41 3541 9330
Email
ma.adeli5515@gmail.com
7
Recruitment center
Name of recruitment center
Sardrood2
Full name of responsible person
Masoumeh deli
Street address
First Street of Seyyed Ahmad
City
Tabriz
Province
East Azarbaijan
Postal code
5361765794
Phone
+98 41 3420 2400
Email
ma.adeli5515@gmail.com
8
Recruitment center
Name of recruitment center
Eram Health Center
Full name of responsible person
Masoumeh Adeli
Street address
AL- Mahdi-Area 8-Township Eram
City
Tabriz
Province
East Azarbaijan
Postal code
5145858356
Phone
+98 41 4948 3230
Email
ma.adeli5515@gmail.com
9
Recruitment center
Name of recruitment center
Gods Health Center
Full name of responsible person
Masoumeh Adeli
Street address
Opposite the Bank-Not reached the Akhuni crossrod-Al-Gods St.
City
Tabriz
Province
East Azarbaijan
Postal code
5183763673
Phone
+98 41 3444 0592
Email
ma.adeli5515@gmail.com
10
Recruitment center
Name of recruitment center
Shafee Health Center
Full name of responsible person
Masoumeh Adeli
Street address
First Shadegan-Akhuni St.
City
Tabriz
Province
East Azarbaijan
Postal code
5185757385
Phone
+98 41 6333 3288
Email
ma.addeli5515@gmail.com
11
Recruitment center
Name of recruitment center
Sadeghi nezhad Health Center
Full name of responsible person
Masoumeh Adeli
Street address
Moallem Blvd-Hojjati St.
City
Tabriz
Province
East Azarbaijan
Postal code
5186943111
Phone
+98 41 2585 3288
Email
ma.adeli5515@gmail.com
12
Recruitment center
Name of recruitment center
Jamshi Abad Health Center
Full name of responsible person
Masoumeh Adeli
Street address
East Feizaye-Hojjati St.
City
Tabriz
Province
East Azarbaijan
Postal code
5185757385
Phone
+98 41 8035 3280
Email
ma.adeli5515@gmail.com
13
Recruitment center
Name of recruitment center
Safa Helth Center
Full name of responsible person
Masoumeh Adeli
Street address
Next to the gas bomber-Better than Maralan's Way-Shahid jodeyri St-Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5163937966
Phone
+98 41 3334 0444
Email
ma.adeli5515@gmail.com
14
Recruitment center
Name of recruitment center
Monajjem Health Center
Full name of responsible person
Masoumeh Adeli
Street address
Staition Naser-Monajjem St.
City
Tabriz
Province
East Azarbaijan
Postal code
5185757385
Phone
+98 41 8428 3282
Email
ma.adeli5515@gmail.com
15
Recruitment center
Name of recruitment center
Shahid sharbati zade Health Center
Full name of responsible person
Masoumeh Adeli
Street address
Engelab St-Engelab square-Eram
City
Tabriz
Province
East Azarbaijan
Postal code
5145858356
Phone
+98 41 3234 0001
Email
ma.adeli5515@gmail.com
16
Recruitment center
Name of recruitment center
Azadi
Full name of responsible person
Masoumeh Adeli
Street address
Telecom staition-Mofatteh
City
Tabriz
Province
East Azarbaijan
Postal code
5144813111
Phone
+98 41 4199 3233
Email
ma.adeli5515@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
Golgasht St.Tabriz University Medical Sciences; Central Building Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 4658 3336
Email
Medical.Libarian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Masoumeh Adeli Gargari
Position
Master Consulation in Miwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 45, 38 Shahid Garaneh ,Shahid Garaneh S.r
City
Hadishar
Province
East Azarbaijan
Postal code
5431974661
Phone
+98 420260224198
Email
ma.adeli5515@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esmat Mehrabi
Position
Ph.Din Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Street South Shariati
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 677034794198
Email
b.mehrabi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoumeh Adeli Gargari
Position
Master Consultant hn Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 45, 38 Shahid Graneh,Shhid Garaneh street
City
Hadishahr
Province
East Azarbaijan
Postal code
5431974661
Phone
+98 420460224198
Email
ma.adeli5515@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