Protocol summary

Summary
This experimental study will be performed on 100 prim gravid women referring to healthcare centers of Zahedan city. After obtaining informed written consent, participants will be divided into two groups of intervention, 50 people each group, using random block sampling. Then demographic information, perceived stress questionnaire, and questionnaire of parental expectations measurement will be completed for both groups. Participants in control group will only receive routine maternal care based on integrated maternal healthcare guidelines which have been approved by ministry of health and implemented in all public healthcare centers from 1385 solar year. Participants of intervention group will receive four ninety-minute training sessions individually and by CDs in addition to routine care. Checklist of daily attachment behavior registration (during 12-16 final weeks of pregnancy) will be given to mothers in intervention group. Telephone follow up will be done by researcher to control attachment behaviors take care three times a week. After 6-8 weeks, questionnaires will be completed by someone who is bland to intervention. Mother infant bonding questionnaire will be completed by participates, during 15 days to four weeks after delivery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015092124108N1
Registration date: 2016-06-30, 1395/04/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-30, 1395/04/10
Registrant information
Name
Roya Kiani
Name of organization / entity
Zahedan University of Medical ScienceSchool of Nursing & Midwifery,
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
r.kiani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Zahedan University of Medical Sciences
Expected recruitment start date
2015-10-07, 1394/07/15
Expected recruitment end date
2016-04-18, 1395/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of attachment behaviors training and routine prenatal care on perceived stress, parental expectations and mother-infant bond in Primigravid women
Public title
The Effects of Teaching Maternal Attachment Behavior on Perceived Stress, Parental Expectations, and Mother- infant bonding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Singleton pregnancy, gestational age of 22-26 weeks, absence of underlying diseases such as diabetes and blood pressure, absence of pre-diagnosed mental diseases such as Schizophrenia, major depression, and hospitalization. Exclusion criteria: Failure to perform intervention correctly and completely (record of attachment behavior less than three or four days a week after intervention of participants during 12-16 final weeks of pregnancy), obstetric problems such as preterm labor and pregnancy complications, and unwillingness to continue cooperation
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: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Zahedan University of Medical Sciences
Street address
Pardis of Zahedan University of Medical Sciences, Dr Hesabi Sq.
City
Zahedan
Postal code
IR.ZAUMS.REC.1394.28
Approval date
2015-10-11, 1394/07/19
Ethics committee reference number
IR.ZAUMS.REC.1394.283

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
Pregnancy
ICD-10 code
Z34.0
ICD-10 code description
Supervision of normal first pregnancy

Primary outcomes

1

Description
perceived stress
Timepoint
Before intervention, six weeks after the end of intervention
Method of measurement
Cohen Perceived Stress Scale - PSS-14

2

Description
Parental expectation
Timepoint
Before intervention, six weeks after the end of intervention
Method of measurement
Reece Parental Expectation Survey

Secondary outcomes

1

Description
The postpartum bonding
Timepoint
Four weeks after delivery
Method of measurement
Brockington Postpartum Bonding Questionnaire

Intervention groups

1

Description
Control group: Pregnancy routine care will be provided based on integrated maternal healthcare guidelines which was approved by ministry of health and implemented in all public healthcare centers from 1385 solar year.
Category
Other

2

Description
Intervention group: Participants of intervention group will receive four ninety-minute training sessions individually and by CDs in addition to routine care. Checklist of daily attachment behavior registration (during 12-16 final weeks of pregnancy) will be given to mothers in intervention group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Musa bin Ja'far Health Center
Full name of responsible person
Roya Kiani
Street address
27 St. Mostafa Khomeini, Zahedan
City
Zahedan

2

Recruitment center
Name of recruitment center
Emam Hasan Mojtaba health Center
Full name of responsible person
Roya Kiani
Street address
16 St. Jame jam, Jame jam Blvd. Zahedan
City
Zahedan

3

Recruitment center
Name of recruitment center
Emam Hadi Health Center
Full name of responsible person
Roya Kiani
Street address
11 St. Janbazan, Janbazan Blvd. Zahedan
City
Zahedan

4

Recruitment center
Name of recruitment center
Seyyed Alshohada Health Center
Full name of responsible person
Roya Kiani
Street address
Mir Hosseini St. Shahid Rajaee Blvd. Zahedan
City
Zahedan

5

Recruitment center
Name of recruitment center
Valiasr Health Center
Full name of responsible person
Roya Kiani
Street address
23 St. Majdieh, Shir Abad, Zahedan
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Zahedan University of Medical Sciences
Full name of responsible person
Houshang Rafighdoost
Street address
Pardis of Zahedan University of Medical Sciences, Dr Hessabi Sq.
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for 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
Zahedan University of Medical Sciences
Full name of responsible person
Roya Kiani
Position
Master Student of Midwifery Counseling
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashaheer Sq.
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
roya48kiani@gmail.comr.kiani@zaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Navidian
Position
Associate Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashaheer Sq.
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
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
Roya Kiani
Position
Master Student of Midwifery Counseling
Other areas of specialty/work
Street address
School Of Nursing and Midwifery, Mashaheer Sq.
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
roya48kiani@gmail.comr.kiani@zaums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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