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Assesment the role effect of consultation on maternal role, parenthood stress and postpartum depression the approach interpersonal psychothrapy in women first-time who have an infant being hospitalized in NICU

Protocol summary

Summary
Present study is a randomized controlled trial, aim of this study is assesment the role effect of consultation on maternal role, parenthood stress and postpartum depression with the approach interpersonal psychothrapy in women first-time who have an infant being hospitalized in NICU in karaj. sampling method will perform according to availability of participants. After obtaining informed consent of participants samples based on quarterly block randomization will be divided into two intervention and control groups. In This study blinding is impossible. Inclusion criteria included: Iranian nationality, fluency in Persian language, singleton, first pregnancy, gestational age of 28-34 weeks, newborns without anomalies, the absence of any known medical or psychological problems as reported by mother herself and Exclusion criteria included: Mother's absence at two consecutive counseling sessions, lack of participation in counseling sessions, and reluctance to continue to participate in the sessions. The study population comprised 92 nulliparous women with newborn in special care in Kamali Hospital of Karaj. Intervention group underwent two consecutive sessions on consecutive days, each session lasting 60 minutes, and a telephone-based follow-up session after two weeks with interpersonal psychotherapy approach.Questionnaires of adaptation to motherhood, parenting stress and postpartum depression will be completed before and after the counseling sessions and two weeks later in both intervention and control groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017022520719N5
Registration date: 2017-05-20, 1396/02/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-20, 1396/02/30
Registrant information
Name
Sara Esmaelzadeh Saeieh
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6007
Email address
s-esmaelzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University of Medical Sciences
Expected recruitment start date
2017-04-19, 1396/01/30
Expected recruitment end date
2017-05-31, 1396/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesment the role effect of consultation on maternal role, parenthood stress and postpartum depression the approach interpersonal psychothrapy in women first-time who have an infant being hospitalized in NICU
Public title
The effect of counseling on maternal role, parenthood stress, postpartum depression in women first-time
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included: Iranian nationality, fluency in Persian language, singleton, first pregnancy, gestational age of 28-34 weeks, newborns without anomalies, the absence of any known medical or psychological problems as reported by mother herself. Exclusion criteria: Mother's absence at two consecutive counseling sessions, lack of participation in counseling sessions, and reluctance to continue to participate in the sessions.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
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
Alborz University of Medical Sciences
Street address
Alborz University of Medical Science, Azimieh, Alborz, Iran
City
Alborz
Postal code
0098
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
Abzums.Rec.1395.152

Health conditions studied

1

Description of health condition studied
Postpartum depression
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified

2

Description of health condition studied
Maternal role
ICD-10 code
F53.9
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified

3

Description of health condition studied
Parenthood stress
ICD-10 code
F53.8
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified

Primary outcomes

1

Description
Postpartum depression
Timepoint
Before the intervention, After the intervention, two week after the intervention
Method of measurement
Edinburgh Depression questionnaire(EPDS)

2

Description
Maternal role
Timepoint
Before the intervention, After the intervention, two week after the intervention
Method of measurement
Maternal role questionnaire

3

Description
Parenthood stress
Timepoint
Before the intervention, After the intervention, two week after the intervention
Method of measurement
Parenthood stress questionnaire in Neonatal Intensive Care Unit Miles(PSS:NICU)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group underwent two consecutive sessions on consecutive days, each session lasting 60 minutes, and a telephone-based follow-up session after two weeks with interpersonal psychotherapy approach. The content of the following sessions was reviewed and confirmed by professors from faculties of nursing, midwifery and children psychology as follows: First session: It contained a description of the aims of the study, necessary care for premature infants, process of the development of the baby, talking to mothers about their concerns and problems, assuming role of motherhood, providing information on assuming role of motherhood, factors hindering and facilitating communication with baby, baby gender issues, symptoms of postpartum depression, providing strategies for coping with stresses. Second session: Providing information on the development and improvement of social protection, identifying and dealing with personal conflicts, problem solving skills, education and improving skills of relationship with wife after the birth of a new baby. Third session: Training on an individual basis and after discharge from the hospital through telephone calls, including follow-up of skills instructed, providing counseling on problems encountered after leaving the hospital, concerns encountered in adapting to motherhood and emphasis on familial support. Meetings are held on consecutive days and the training in which educational and counseling skills such as group discussion, role playing, problem solving skills are used. Questionnaires of adaptation to motherhood, parenting stress and postpartum depression will be completed before and after the counseling sessions and two weeks later in both intervention and control groups And analyzed using spss software will be.
Category
Behavior

2

Description
control group: Receive routine care
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamali Hospital - Neonatal Intensive Care Unit
Full name of responsible person
Maryam Rasouli
Street address
Martyr Beheshti Avenue, Martyrs Square, Kamali Avenue, kamali Hospital
City
Alborz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alborz University of Medical Sciences-Vice President of Research
Full name of responsible person
Mohammad Noorisepehr
Street address
The Research Choncellor Department Of Alborz Medical University, Azimieh Square, Alborz, Iran
City
Alborz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz University of Medical Sciences-Vice President of Research
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
Research Assistant Alborz University of Medical Sciences
Full name of responsible person
Katayoon Salehi
Position
Master of Research
Other areas of specialty/work
Street address
Azymyh Square , Research Assistant Alborz Univercity of Medical Sciences
City
Alborz
Postal code
0098
Phone
+98 26 3452 9133
Fax
Email
salehi.katayoun@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Sara Esmaelzadeh Saeieh
Position
Faculty Member, phD
Other areas of specialty/work
Street address
School Of Nursing And Midwify, first Golestan, Baghestan, Alborz
City
Alborz
Postal code
0098
Phone
+98 26 3452 9133
Fax
Email
Esmaelzaded1360@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Sara Esmaelzadeh Saeieh
Position
Faculty Member - phD
Other areas of specialty/work
Street address
School Of Nursing And Midwify, first Golestan, Baghestan, Alborz
City
Alborz
Postal code
0098
Phone
+98 26 3452 9133
Fax
Email
Esmaelzadeh1360@gmail.com
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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