Protocol summary

Study aim
Determining the effect of midwifery counseling with cognitive-behavioral approach on maternal،fetal attachment and anxiety in mothers with abortion history
Design
This study was a randomized clinical trial with two groups (test and control). There are 33 pregnant women with abortion history that are available in each group. Blind is on the side.
Settings and conduct
The prenatal center of Shahid Sadoughi Hospital in Yazd is based on objective sampling
Participants/Inclusion and exclusion criteria
teria for entering the study: Mothers who have literacy and reading skills, mothers with pre-pregnancy and abortion, gestational age 27-30 weeks, and physiologically and physically healthy, are able to attend and participate actively in the classroom, have an anxiety score. Low to moderate (80-20) based on Spielberger anxiety scale; Exit criteria: having recurrent abortions, having acute obstetric problems associated with pregnancy, and having a history of serious psychiatric disorders, unwillingness to participate in research, use of psychoactive drugs before From pregnancy and during pregnancy by couples, it is suddenly taken To abnormal stress due to life-threatening events in the last 1 month, multiple pregnancies
Intervention groups
The statistical population of this study is all pregnant women with a history of abortion and childbirth and 27-30 weeks pregnancy referred to the prenatal center of Shahid Sadoughi Hospital in Yazd. If the conditions for entering the research were divided into two groups, the control group was randomly divided into 33 groups each group. The midwifery counseling group with a cognitive-behavioral approach was held during 6 sessions and the control group received routine prenatal care They give.
Main outcome variables
Anxiety; maternal، fetal attachment

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20170802035446N2
Registration date: 2018-10-17, 1397/07/25
Registration timing: retrospective

Last update: 2018-10-17, 1397/07/25
Update count: 0
Registration date
2018-10-17, 1397/07/25
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3252 6897
Email address
arianmokhtari2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-10, 1396/09/19
Expected recruitment end date
2018-06-19, 1397/03/29
Actual recruitment start date
2018-02-09, 1396/11/20
Actual recruitment end date
2018-06-10, 1397/03/20
Trial completion date
1988-09-01, 1367/06/10
Scientific title
The effectiveness of midwifery counseling based on cognitive-behavioral approach on anxiety and maternal - fetal attachment among mothers with past history abortion referring prenatal care shahid Sadoughi center Yazd
Public title
Investigating the effect of counseling with cognitive-behavioral approach on maternal attachment-anxiety in mothers with abortion history
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
-Madrid who are literate to read and write. Pregnant mothers, without children, and abortions 3- Gestational age 27-30 weeks 4. Mothers who were physiologically and physically able to attend and participate actively in the classroom (vision, hearing, etc.). Having low to moderate anxiety score (80-20) based on Spielberger anxiety scale
Exclusion criteria:
Having repeated abortions 2- Acute obstetric and pregnancy related problems (severe gestational infertility, bladder pains, bleeding ...) 3. Having a history of serious psychiatric disorders 5- The use of psychotropic drugs before pregnancy and during pregnancy by couples 6. Sudden onset of abnormal stress caused by unpleasant events of life in the last 1 month, such as: the death of a spouse, divorce, separation and disgust with a spouse, the death of a close member of a family 7. Multiple pregnancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Among them, the mothers who have entered the study (goal-based sampling) are selected as the sample and randomly divided into two groups (test and control). The random allocation rule is the simplest method of randomization. This method represents a large block for the entire sample size, which means that the balance in the number of people assigned to each of the groups will be at the end of the study. To do this, first determine a total sample size and then randomly assign a set of them to Group A and assign the remainder to Group B. This method is applicable to trials in two or more groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
he population of this study is pregnant women referred to the prenatal center of Shahid Sadoughi Hospital in Yazd. Among them, the mothers who are eligible for inclusion in the study are selected as a research sample (simple sampling based on the goal) and randomly assigned to two groups.To select the samples, the researcher is first and foremost in the prenatal center of Shahid Sadoughi Hospital in Yazd. After identifying the eligible patients, they will be asked to enter the study after explaining the goals of the plan and obtaining written consent from their mothers and their wives. At the next stage, mothers are asked to complete the Spielberger Anxiety Scale questionnaire. Spielberger's Anxiety Scale Scale (Low to Moderate Scale) is one of the requirements for entering the study. Mothers who receive Spielberger's Scale of Inferiority Scale (20-80) are asked to complete demographic information and maternal and cranial attachment questionnaires. They will be referred to a psychiatrist if they have a higher anxiety score. . Mothers participate in 6 counseling sessions in the test group. At the same time, counseling groups are being set up in five, while in the control group there is no intervention and routine pregnancy care and a physiological delivery class are provided. At the end of the intervention (one week after the last counseling session), both groups completed the Cranly questionnaire and the Spielberger anxiety scale again. Finally, the data will be analyzed by SPSS software and the results will be reported.
Placebo
Not used
Assignment
Parallel
Other design features
Study of the effect of midwifery counseling on psychological approach

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
Central Office of Shahid Sadoughi University of Medical Sciences and Health Services of Yazd, Shahid Bahonar Square,Yazd,
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-10-10, 1396/07/18
Ethics committee reference number
ir.ssu.rec.1396.115

Health conditions studied

1

Description of health condition studied
Mother's attachment to fetus
ICD-10 code
F53.8
ICD-10 code description
Other mental and behavioural disorders associated with the puerperium, not elsewhere classified

2

Description of health condition studied
anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Maternal attachment score
Timepoint
Before the intervention and one week after the end of the last counseling session
Method of measurement
Cranelian questionnaire

2

Description
anxiety score
Timepoint
Before the intervention and one week after the end of the last counseling session
Method of measurement
Spielberger questionnaire

Secondary outcomes

1

Description
Quality Score
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Short-Form Health Survey Ware؛ Sherbourne questionnaire

Intervention groups

1

Description
Intervention group: Mothers who have anxiety scores of low to moderate anxiety scores and other entry conditions are enrolled in the study and their counseling classes are grouped in six sessions of 1.5 hours.
Category
Behavior

2

Description
Control group: Control group: The control group included 33 people who only receive routine center of maternity care services and physiological delivery classes.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Abnecenna Blvd, Shahid Ghandi Boulevard, Yazd
Full name of responsible person
Zohreh Shayegh
Street address
Abnecenna Blvd
City
Yazd
Province
Yazd
Postal code
8916886931
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
Shayegh0203@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Masood Mirzaie
Street address
Yazd, Central Office of Shahid Sadoughi University of Medical Sciences and Health Services Yazd, Shahid Bahonar Square
City
Yazd
Province
Yazd
Postal code
8915993830
Phone
+98 35 3827 8568
Email
shayegh0203@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Zohreh Shayegh
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
the third Alley of Hojjat، Kashani street
City
Yazd
Province
Yazd
Postal code
8915993830
Phone
+98 35 3827 8568
Email
Shayeg0203@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shahnaz Mojahed
Position
Professor and faculty member of the university
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Midwifery، Bouali Ave.,Safaieh
City
Yazd
Province
Yazd
Postal code
8949333865
Phone
+98 35 2824 9704
Email
sh_mojahed@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zohreh Shayegh
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Hojat Third Alley، Kashani Street
City
Yazd
Province
Yazd
Postal code
8915993830
Phone
+98 35 3827 8568
Email
shayegh0203@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
According to the opinion of the university and the supervisor.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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