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The Effect of Telenursing on Maternal-Infant Attachment and Stress among Premature Infant’s Mothers who Hospitalized in Neonatal Intensive Care Unit of the Shahid Beheshti Hospital 2017.

Protocol summary

Summary
Objective: This study aimed to determine the efficacy of Telenursing on maternal-infant attachment and stress on preterm infant’s mothers in NICU. Design: This study is a clinical trial that will be conducted in Isfahan. Setting and conduct: In this study, 50 mothers of preterm infants with inclusion criteria admitted in NICU of the Isfahan Shahid Beheshti hospital randomly assigned to an experimental group and a control group. Participants including major eligibility criteria: Gestational Age 33-37 week with no evidence of physical or congenital problem and no Deterioration of their disease. Intervention: In the experimental group within seven days after birth until a week after discharge nursing education with Telenursing will be done by telephone system. This telephone system consist of two parts offline and online. Off line system have 10 codes with recorded information about NICU, characterization of premature newborns, changes of weight, length and head circumstances in premature newborns, therapeutic procedures in premature newborns, equipment in NICU, relaxing premature newborns, different methods of feeding in premature newborns, breast milk storage and handling, ways of increasing milk expression, listening to relaxation voice messages. The offline system will be always available by phone during 24 hours. In online part mothers can contact to the researcher and ask their questions. Control groups received only routine interventions. variables: During seven days after birth both groups will complete Parental Stress Scale: Neonatal Intensive Care Unit (PSS:NICU) and Maternal Postnatal Attachment (MPA) scale, on the day of discharge they will complete PSS:NICU and a week after discharge, they will complete MPA scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017052034040N1
Registration date: 2017-11-06, 1396/08/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-06, 1396/08/15
Registrant information
Name
Zahra Alsadat Jafarzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3688 0048
Email address
zs.jafarzadeh@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-06-10, 1396/03/20
Expected recruitment end date
2017-11-11, 1396/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Telenursing on Maternal-Infant Attachment and Stress among Premature Infant’s Mothers who Hospitalized in Neonatal Intensive Care Unit of the Shahid Beheshti Hospital 2017.
Public title
The Effect of Telenursing on Maternal-Infant Attachment and Stress on Premature Infant’s Mothers.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Mother’s consent to participate the study؛ Mothers who able to read and write؛ Parents who are non-employed in medical and paramedical jobs ؛No evidence of maternal physical or psychological condition that effect maternal supportive care role like postpartum depression, anxiety, addiction؛ No evidence of major stress like divorce, impersonate of husband or death of family member during last year; Gestational Age 33-37 weeks; Newborns who have taken Kangaroo Mother Care(KMC); No evidence of neonatal extreme condition like grades third or fourth Internal Ventricular Hemorrhage (IVH) or physical or congenital problem; Mothers who are not participating in any other research. Exclusion criteria: Intention of mothers to leave the study; Evidence of any maternal physical or psychological problem during the study that prevent her to do supportive care role for her neonate; Less than two contacts from the mothers; Discharge of newborns before the end of the study; Deterioration of the disease, or death of the neonates;
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Ethics committee of Isfahan University of Medical Science, Nursing Midwifery School, Isfahan University of Medical Science, Hezarjereeb Street, Isfahan, Iran
City
Isfahan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Approval date
2017-02-19, 1395/12/01
Ethics committee reference number
IR.MUI.REC.1390.3.899

Health conditions studied

1

Description of health condition studied
stress
ICD-10 code
R45.7
ICD-10 code description
State of emotional shock and stress

2

Description of health condition studied
attachment
ICD-10 code
F93
ICD-10 code description
Emotional disorders with onset specific to childhood

Primary outcomes

1

Description
stress
Timepoint
During seven days after birth, The day of dischare.
Method of measurement
Stress with Parental Stress Scale: Neonatal Intensive Care Unit (PSS:NICU)

2

Description
attachment
Timepoint
During seven days after birth, One week after discharge
Method of measurement
Maternal Postnatal Attachment (MPA).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group receive Telenursing. Telenursing consist of two parts (offline and online). Off line system have 10 codes with recorded information about NICU, characterization of premature newborns, changes of weight, length and head circumstances in premature newborns, therapeutic procedures in premature newborns, equipment in NICU, relaxing premature newborns, different methods of feeding in premature newborns, breast milk storage and handling, ways of increasing milk expression, listening to relaxation voice messages) and the offline system will be always available by phone during 24 hours. In online part mothers can contact to the researcher and ask their questions. Telenursing starts with in a week after newborn hospitalization until a week after discharge.
Category
N/A

2

Description
Control groups received only routine interventions. Before discharge all samples receive pamphlet about Kangaroo Mother Care (KMC).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Zahra Alsadat Jafarzadeh
Street address
Shahid Beheshti, Ostad Motahari street, Isfahan, Iran.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice for research, Isfahan University of Medical Sciences
Full name of responsible person
Sara Arti
Street address
nursing midwifery school, Isfahan University of Medical Science, Hezarjereeb Street, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice for research, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Zahra Alsadat Jafarzadeh
Position
postgraduated nursing student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjereeb street, Isfahan, Iran.
City
Isfahan
Postal code
81969-38511
Phone
+98 31 3688 0048
Fax
+98 31 3458 6881
Email
zahraalsadatjafarzadeh@gmail.comzs.jafarzadeh@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zahra Alsadat Jafarzadeh
Position
postgraduated nursing student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjereeb street, Isfahan, Iran.
City
Isfahan
Postal code
81746-73461
Phone
+98 31 3688 0048
Fax
+98 31 3458 6881
Email
zs.jafarzadeh@nm.mui.ac.ir zahraalsadatjafarzadeh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zahra Alsadat Jafarzadeh
Position
post graduated nursing student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjereeb street, Isfahan, Iran.
City
Isfahan
Postal code
81746-73461
Phone
+98 31 3688 0048
Fax
+98 31 3458 6881
Email
zs.jafarzadeh@ nm.mui.ac.irzahraalsadatjafarzadeh@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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