Determining the effect of counseling based on Gamble's approach on psychological birth trauma in primigravid women
Design
Randomized clinical trial with a control group, on 74 pregnant women in parallel groups
Settings and conduct
Pregnant women referred to the maternity care clinic of Umm Al Binin Hospital who have inclusion criteria are randomly assigned into two groups of control and intervention.
In the intervention group, counseling by the midwife is performed on the basis of the Gamble's strategy individually for 3 sessions before delivery and one session after delivery.For the control group, routine prenatal care is provided
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mother's willingness and consent to participate in the study; Residence in Mashhad; primigravid; Aged18-35 years; Reading and writing literacy; Gestational age 35 weeks; Single and healthy pregnancy; Wanted pregnancy; Phone Access.
Exclusion criteria: En fetal abnormalities in ultrasound; post traumatic stress disorder; high risk pregnancy; medical disorder; history of infertility or abortion.
Intervention groups
In the intervention group, counseling by the midwife is performed on the basis of the Gamble's strategy individually for 3 sessions before delivery and one session after delivery.For the control group, routine prenatal care is provided.
Main outcome variables
psychological birth trauma and its five dimensions include: anxiety and hot birth, mental manifestations, helplessness, collapse and a sense of death, physical manifestations
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180520039747N1
Registration date:2018-10-31, 1397/08/09
Registration timing:registered_while_recruiting
Last update:2018-10-31, 1397/08/09
Update count:0
Registration date
2018-10-31, 1397/08/09
Registrant information
Name
Zahra Hajarian Abhari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 7528
Email address
hajarianz951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-05, 1397/05/14
Expected recruitment end date
2019-02-03, 1397/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based on Gamble's approach on psychological birth trauma in primigravid women
Public title
The effect of counseling based on Gamble's approach on psychological birth trauma in primigravid women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mother's willingness and consent to participate in the study
Residence in Mashhad
primi gravid
Aged 18-35 years
Reading and writing literacy
Gestational age 35 weeks
Single and healthy pregnancy
Wanted pregnancy
Phone Access
Exclusion criteria:
fetal abnormalities in ultrasound
post traumatic stress disorder
high risk pregnancy
medical disorder
history of infertility or abortion
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:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling into intervention and control groups with simple randomization method using Spss software
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 Mashhad University of Medical Sciences
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-06-18, 1397/03/28
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.006
Health conditions studied
1
Description of health condition studied
psychological birth trauma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
psychological birth trauma
Timepoint
6-12 hours after intervention
Method of measurement
psychological birth trauma Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, counseling by the midwife is performed on the basis of the Gamble's strategy individually for 3 sessions before delivery and one session after delivery.
Category
Prevention
2
Description
Control group: In the control group, routine prenatal care is provided.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
ommol-Banin Specialized Obstetrics and Gynecology Hospital
Full name of responsible person
Dr. Fatemeh Tara
Street address
Ayatolah Bahjat street
City
Mashhad
Province
Razavi Khorasan
Postal code
9144663595 91446635
Phone
+98 51 3223 1061
Fax
+98 51 3223 1444
Email
oah.it@mums.ac.ir
Web page address
http://woman.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Darabi Mahboob
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
hajarianz951@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Hajjarian Abhari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Danehgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
hajarianz951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Karimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
karimiFZ@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Karimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
karimiFZ@mums.ac.ir
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
Not applicable
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