The effect of psychological immunization strategy on fear of childbirth in childparents primiparous woman
Design
sixty four people with inclusion criteria will be included in the study and will be divided into two equal groups including A (intervention group) and B (control group). Individuals will enter to groups randomly using blocks with size of 4 and through a table of random numbers.
Settings and conduct
The study site will be health centers affiliated to Qom University of Medical Sciences. Using the information of the Sib system, the researcher will select the centers that have the highest number of references of childparents for sampling. For the intervention group, ten sessions of mental safety training classes plus 8 sessions of childbirth preparation classes will be held, and for the control group, only 8 sessions of childbirth preparation classes will be held. In this study, there is no possibility of blindness.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Willingness to participate in the study؛ Be literate؛Smartphone access؛
20 weeks gestational age؛ Singleton؛ Absence of pregnancy complications such as bleeding and preeclampsia؛primiparous؛ mother age less than 18 years؛ Participate in childbirth preparation classes،
Exclusion criteria:
history of infertility؛ having chronic diseases؛ having known mental illness
Intervention groups
The intervention group includes pregnant mothers under 18 years of age who will receive ten sessions of mental immunization training classes in addition to 8 sessions of childbirth preparation classes.
The control group includes pregnant mothers under 18 years of age ( child-parent) who will receive the intervention including 8 sessions of childbirth preparation classes.
Main outcome variables
fear of childbrith
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160821029446N10
Registration date:2022-01-15, 1400/10/25
Registration timing:prospective
Last update:2022-01-15, 1400/10/25
Update count:0
Registration date
2022-01-15, 1400/10/25
Registrant information
Name
Maryam Damghanian
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
m-damghanian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of psychological immunization strategy on fear of childbirth in childparents primiparous woman
Public title
The effect of psychological immunization strategy on fear of childbirth
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Be literate
Smartphone access
20 weeks gestational age
Singleton
Absence of pregnancy complications such as bleeding and preeclampsia
primiparous
mother age less than 18 years
Participate in childbirth preparation classes
Exclusion criteria:
history of infertility
having chronic diseases
having known mental illness
Age
To 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of samples to intervention (A) and control (B) groups (32 people in each group) will be done using blocks with size of 4. In this way, 6 possible modes will be considered using a table of random numbers. These 6 modes are written on 6 separate cards and the cards will be placed in a black bag (for concealment) . A card will be issued for 16 times to finally get 64 letters written as the sample size. The intervention group will be the group that will receive psychological immunization training sessions in addition to childbirth preparation classes, and the control group will be the group that will receive only childbirth preparation classes.
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 the School of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
Tohid square,Dr. Mirkhani Street (eastern nosrat)
City
tehran
Province
Tehran
Postal code
1419733171
Approval date
2021-11-04, 1400/08/13
Ethics committee reference number
IR.TUMS.FNM.REC.1400.145
Health conditions studied
1
Description of health condition studied
fear of childbirth
ICD-10 code
F40.232
ICD-10 code description
Fear of other medical care
Primary outcomes
1
Description
Fear of childbirth score in Vijma questionnaire
Timepoint
At the beginning of the study and after the intervention
Method of measurement
Vijama Maternity Fear / Expectation Questionnaire Version A
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:the intervention group will be given Ten sessions of mental immunization training. These sessions will be held two one-hour sessions per week (five weeks in total) from the twentieth week of pregnancy. Psychological immunization sessions will be conducted in the form of individual interviews (In the form of talking in class), Perform relaxation techniques, Examining mothers' opinions and fears about childbirth, Examination of environmental and internal stressors and Factors that cause fear in mothers, Answer all these symptoms, Teaching relaxation techniques,Teaching coping techniques against stress, Giving correct information to mothers, Assessing mothers' sense of adequacy and teaching them the necessary points, Expressing mothers' feelings and fears and etc. So far in Iran, the education with this technique has not been performed on mothers. These interventions are designed to evaluate the effectiveness of this technique in the primiparous child parent woman. None of this is covered in childbirth preparation classes.
Category
Behavior
2
Description
Control group: No action is taken for members of the control group. These people receive routine pregnancy care. Once before the intervention in the intervention group and once after the training sessions in the intervention group, the Vijma questionnaire will be filled out by the control group at the same time as the intervention group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom health centers
Full name of responsible person
Najmeh Taghian
Street address
School of Nursing & Midwifery, Tehran University of Medical sciences. Tohis sq, Tehram, Ian
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
najm9276@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
dr homan shahsavari
Street address
School of Nursing & Midwifery, Tehran University of Medical sciences. Tohis sq, Tehram, Ian
City
tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fnm@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
najmeh taghiyan
Position
دانشجوی کارشناس ارشد مامایی
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, tehran university of medical science, tohid sq, Twhran, Iran
City
tehran
Province
Tehran
Postal code
1499733171
Phone
+98 21 6692 7171
Email
najm9276@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, Tehran University of Medical sciences, Tohid sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733172
Phone
+98 21 6105 4000
Email
maryam_damghanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
maryam damghanian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, Tehran University of Medical Scienses, tohid sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733172
Phone
+98 21 6692 7171
Email
maryam_damghanian@yahoo.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