Aims: To study the effect of psychological training on anxiety and attachment of mother to fetus in post-partum pregnancy. Design: This is a semi-experimental study with pretest and posttest design. Population: Includes women who after the birth of a dead baby in pregnancy. Previously, they were pregnant again and have entry criteria. The sample size is 100 people randomly divided into two groups of intervention and control. At first, the total number of enrolled subjects will be provided with study groups (A intervention and B control) and will be arranged randomly. Gradually, by identifying the eligible person, one of the envelopes will be allocated to the selected individuals, respectively. The questionnaires will then be described by the researcher or his colleague and completed by the participants as a pretest. For the intervening intervention group, four sessions of the psychological training program Within 2 weeks and on the basis of the specified content, they will receive the educational materials during the sessions. After 6 weeks, the research questionnaires are completed as a post-test for both groups. Finally, the CD and the educational booklet are also given to the control group. Entry criteria: Pregnancy up to one year after the birth. Grades: Absence or absence of more than one training session. Ultimately, the anxiety and maternal attachment to the fetus are compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017110429954N6
Registration date:2017-11-09, 1396/08/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-09, 1396/08/18
Registrant information
Name
Ali navidian
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
alinavidian@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Zahedan University of Medical Sciences
Expected recruitment start date
2017-06-15, 1396/03/25
Expected recruitment end date
2017-11-16, 1396/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of psychosocial education on anxiety and attachment of mother to fetus in pregnancy after stillbirth
Public title
The effect of psychological training on anxiety and attachment of mother after stillbirth
Purpose
Supportive
Inclusion/Exclusion criteria
Entry criteria: Age over 18 years old pregnant mother - Pregnancy up to one year after gestational age and non-pregnancy-High-risk pregnancy-Multiple pregnancies-No experience of stillbirth more than one time or abortion -One pregnancy 20-30 weeks -No existence Known psychiatric disorders and lack of addiction-lack of psychosocial crisis, such as the death of loved ones or the occurrence of serious problems and serious illness in the last 6 months. Exit criteria: Incidence of pregnancy problems (bleeding, runny nose, preeclampsia), admission and termination of pregnancy-absence or absence of more than one training session
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Dr. Hesabi Square
City
Zahedan
Postal code
9816743463
Approval date
2017-06-12, 1396/03/22
Ethics committee reference number
IR.ZAUMS.REC.1396.56
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
2
Description of health condition studied
Mother's attachment to the fetus
ICD-10 code
F94.2
ICD-10 code description
Disinhibited attachment disorder of childhood
3
Description of health condition studied
Stillbirth
ICD-10 code
Z37.1
ICD-10 code description
Single stillbirth
Primary outcomes
1
Description
Mother's attachment to the fetus
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
Cranly questionnaire
2
Description
Anxiety
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
PRAQ-17 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the questionnaires are completed as a pre-test. For the intervention group, the researcher will have four sessions of psychological training in a group-community for two weeks at the relevant health / health center and will be provided with CDs and educational materials. Six weeks later, the questionnaires will be filled in again as a post-test
Category
Rehabilitation
2
Description
Control group: First, the questionnaires are completed as a pre-test. The control group will not receive any intervention other than routine care, after 8 weeks, the post-test will be given and, if desired, the CD control group and other training materials will be given to them.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Comprehensive Health Services
Full name of responsible person
Ms. Salari
Street address
In front of Majdieh 23
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Zahedan University of Medical Sciences
Full name of responsible person
Normohammad Bakhshani
Street address
Zahedan University of Medical Sciences, Dr. Hesabi Square
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty of Zahedan
Full name of responsible person
Mehrnegar Azogh
Position
MSc Student
Other areas of specialty/work
Street address
Zahedan Nursing and Midwifery Faculty, Mashahir Square
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2452
Fax
Email
m.azogh72@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Ali Navidian
Position
Associate Professor of Zahedan University of Medical Sciences
Other areas of specialty/work
Street address
Zahedan,mashahir Square, Zahedan Nursing and Midwifery Faculty
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2452
Fax
Email
alinavidian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mehrnegar Azogh
Position
Student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Mashahir Square
City
Zahedan
Postal code
9861867969
Phone
+98 54 3223 8017
Fax
Email
m.azogh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)