Determining the effect of cognitive-behavioral counseling on mother-fetus attachment in adolescent mothers
Design
Clinical trial with intervention and control groups and the volume of each group was 6 people, randomized by blocking method
Settings and conduct
Samples will be selected from pregnant women referring to Dayyer city health centers by available sampling method. Those who scored low on the Cranley's Maternal Attachment Questionnaire will be selected. The samples are randomly divided into twelve blocks of six and are assigned to the intervention and control groups. In the intervention program, individuals are divided into groups of six.
Participants/Inclusion and exclusion criteria
Inclusion criteria: primiparous mothers, maternal age from 15 to 19 years, no maternal physical or mental illness confirmed by a doctor and psychiatrist, having at least a Middle school degree, gestational age of at least 28 weeks and mother-fetus attachment Low (based on the score of the first quarter questionnaire) and exclusion criteria: cancellation of further research, incomplete completion of questionnaires, absence of more than two sessions in counseling sessions, fetal death and divorce.
Intervention groups
In the intervention group, in addition to receiving routine pregnancy care, women also participate in 6-person group sessions of cognitive-behavioral counseling. In the control group, women receive only routine pregnancy care.
Main outcome variables
Maternal-fetal attachment in adolescent mothers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220605055078N1
Registration date:2022-06-14, 1401/03/24
Registration timing:prospective
Last update:2022-06-14, 1401/03/24
Update count:0
Registration date
2022-06-14, 1401/03/24
Registrant information
Name
Somayeh Mohammadsoori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3665 4015
Email address
smsoori.as@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-19, 1401/03/29
Expected recruitment end date
2022-10-20, 1401/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive-behavioral counseling on maternal-fetal attachment in adolescent mothers
Public title
The effect of counseling on maternal-fetal attachment in adolescent mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous mothers
Mother age from 15 to 19 years
The mother does not have an underlying physical or mental illness confirmed by a doctor and psychiatrist
Have at least a Middle school deploma
Gestational age at least 28 weeks
Existence of low attachment (based on the score of the first quarter questionnaire score 48)
Exclusion criteria:
Withdrawal from continuing research
Incomplete of questionnaires
Absence of more than two sessions in counseling sessions
Fetal death
Divorce
Age
From 15 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by continuous sampling and will be divided into intervention and control groups by Block Balanced Randomization (BBR). The allocation sequence will be done using the free web system http://www.randomization.com/. In this way, the number of subjects in each block is determined by 6 people and the letter A will be considered for the intervention group and the letter B will be considered for the control group. The assignment sequence will be created for 72 samples by combining the letters A and B. Finally, the cards containing the blocks will be placed inside the standard envelope, and as a result, the Allocation Concealment will be considered and observed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, School of Nursing and Midwifery, Golestan St
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Approval date
2022-05-30, 1401/03/09
Ethics committee reference number
IR.AJUMS.REC.1401.094
Health conditions studied
1
Description of health condition studied
Relationship between cognitive-behavioral counseling on maternal and fetal attachment in adolescent mothers.
ICD-10 code
F69
ICD-10 code description
Unspecified disorder of adult personality and behavior
Primary outcomes
1
Description
Maternal-fetal attachment score of adolescent mothers in Cranley fetal-maternal attachment questionnaire
Timepoint
Completion of maternal-fetal attachment questionnaire before intervention, end of intervention and one month after intervention.
Method of measurement
Cranley's Maternal-Fetal Attachment Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Adolescent women with low maternal attachment score to the fetus receive 8 sessions of cognitive-behavioral counseling for 8 consecutive weeks. The number of people in the groups will be 6 and the duration of each session will be about 45 minutes. Each session has an educational purpose and during the session, they perform cognitive-behavioral change techniques. Homework is also recommended for women to permanently change the behavior appropriate to the topic of each session to increase maternal-fetal attachment to women.
Category
Behavior
2
Description
Control group: Receive routine prenatal care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Urban health centers
Full name of responsible person
Somayeh mohammadsoori
Street address
Moallem Boulevard in front of the radio and television, Dayyer city health Network
City
Dayyer
Province
Boushehr
Postal code
7557174373
Phone
+98 77 3542 3676
Fax
+98 77 3542 3802
Email
smsoori.as@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی جندی شاپور اهواز
Full name of responsible person
Mehdi Ahmadimoghadam
Street address
Golestan St. Jundishapur University of Medical Sciences
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی جندی شاپور اهواز
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
Ahvaz University of Medical Sciences
Full name of responsible person
Somayeh mohammadsoori
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ashuri Street
City
Kangan
Province
Boushehr
Postal code
7557174373
Phone
009866364015
Email
smsoori.as@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojgan javadnoori
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan St
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
009833114114
Email
javadnoori-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Somayeh Mohammadsoori
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ashuri Street
City
Kangan
Province
Boushehr
Postal code
7557174373
Phone
+98 66 3665 4015
Fax
Email
smsoori.as@gmail.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