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The Effects of Tele-nursing on stress in Mothers with Premature Infants after discharge from Neonatal Intensive Care Unit

Protocol summary

Study aim
This study aims to investigate the effects of Tele-nursing on mothers’ level of stress after their infants ’are being discharged from the Neonatal Intensive Care Unit (NICU).
Design
A Quasi experimental research, randomized, two groups of intervention and control, 120 Sample ,
Settings and conduct
This study was conducted in the NICUs of the selected hospitals, affiliated with the universities of medical sciences in Mazandaran Province (the hospitals Imam Khomeni, Razi, Bu-Ali-Sina).In the intervention group Tele-nursing was performed for 4 weeks through Telegram application.The data was gathered in three Stages (the day after discharge, one day after the intervention and four weeks after it. Data collection was done using Barry and Jones’ parental stress scale, and the maternal and neonatal demographic questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria included the ability to read and write in Farsi, having a cell phone that supports Telegram application, not taking infertility treatment methods and giving singleton birth; The exclusion criteria included the mother’s acute illness; the mother’s not being available for more than a week.
Intervention groups
intervention (tele-nursing) included Education, Consultation and follow-ups. Education was provided for mothers in the form videos, photos, instructive texts and Q&A Stages on Telegram installed on their mobile phones , within four consecutive weeks that providing care for the Premature infants. The possibility of phone counseling, provided for the mother 24 hours a day. The follow-ups were done by calling mothers every weekend in order to ask about the content of the previous week’s session and create educational feedback. control group received only the care conventionally provided in the ward at the time of discharge.
Main outcome variables
Change in maternal stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161024030474N2
Registration date: 2019-06-16, 1398/03/26
Registration timing: retrospective

Last update: 2019-06-16, 1398/03/26
Update count: 0
Registration date
2019-06-16, 1398/03/26
Registrant information
Name
Azam Shirinabadi Farahani
Name of organization / entity
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21886553668
Email address
farahani1381@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-30, 1396/08/08
Expected recruitment end date
2018-06-19, 1397/03/29
Actual recruitment start date
2017-10-30, 1396/08/08
Actual recruitment end date
2018-03-19, 1396/12/28
Trial completion date
2018-06-19, 1397/03/29
Scientific title
The Effects of Tele-nursing on stress in Mothers with Premature Infants after discharge from Neonatal Intensive Care Unit
Public title
The Effects of Tele-nursing on stress in Mothers with Premature Infants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The ability to read and write in Farsi. Being infant’s biological mother. The mother’s not having chronic anxiety and stress based on her own statements. Not to be a health care provider. The infant’s being hospitalized At least for a week. The infant’s being hospitalized only due to prematurity. Having a cell phone that supports Telegram application. Their babies are not discharged with family consent (Leave with personal responsibility). Not taking infertility treatment methods and giving singleton birth Live with their spouse. Their babies having no congenital anomalies and genetic defects.
Exclusion criteria:
Mother’s acute illness. Re-admission of the infant before or during the study due to various diseases. The mother’s not being available for more than a week. The lack of interest in contributing to the research anymore.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Actual sample size reached: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were randomly assigned to the two groups of intervention and control based on their case reference number: the even numbers were assigned to the control group and the odd numbers to the intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The samples were randomly assigned to the two groups of intervention and control. the intervention group received the intervention for 4 weeks and there was no intervention in the control group.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Pharmacy, Nursing and Midwifery Schools. Shahid Beheshti University of Medical S
Street address
no 8, Shams Ally, Tavanir, Vally Asr Blvd
City
Tehran
Province
Tehran
Postal code
193954719
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.SBMU.PHNM.1395.697

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Stress score on Barry and Jones’ parental stress scale
Timepoint
The day after discharge (before the intervention). 1 and 30 days after the end of the intervention.
Method of measurement
Barry and Jones’ parental stress scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Tele-Nursing (training, counseling and telephone follow up by the nurse) was conducted for 4 weeks.
Category
Prevention

2

Description
Control group: Receive routine education at discharge
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Dr. Mozafar Shabani
Street address
Yoosef Reza Ave
City
Qaemshahr
Province
Mazandaran
Postal code
4765686743
Phone
+98 11 4221 8018
Fax
+98 11 4221 8011
Email
razi-ghh@mazums.ac.ir
Web page address
http://razihospital.mazums.ac.ir/

2

Recruitment center
Name of recruitment center
Boali Sina hospital
Full name of responsible person
Dr. Abdollah Mosavi
Street address
Emam Khomeyni Sq, Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
1234567891
Phone
+98 11 3334 3010
Fax
+98 11 3334 3017
Email
boalihospital@mazums.ac.ir
Web page address
http://boalihospital.mazums.ac.ir/

3

Recruitment center
Name of recruitment center
Imam khomeyni hospital
Full name of responsible person
Dr. Misagh Shafizade
Street address
Razi Street
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 3754
Email
imamhospital@mazum.ac.ir
Web page address
http://imamhospital.mazums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences - Next to Taleghani Hospital - Shahid Abbas Aerebi St. (Parvaneh) - Yemen Street - Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
farahani1381@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirinabadi Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti University of Medical Sciences, School of Nursing & Midwifery, Niayesh Cross Road, Vali Asr Ave.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2518
Email
farahani1381@sbmu.ac.ir
Web page address
http://nm.sbmu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirinabadi Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti University of Medical Sciences, School of Nursing & Midwifery,Niayesh Cross Road, Valiasr Ave..
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
farahani1381@sbmu.ac.ir
Web page address
http://nm.sbmu.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirinabadi Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti University of Medical Sciences,School of Nursing and Midwifery, Niayesh Cross Road, Vali Asr Ave.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
farahani1381@sbmu.ac.ir
Web page address
http://nm.sbmu.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome (maternal stress) can be shared.
When the data will become available and for how long
Immediately after the publication of the article
To whom data/document is available
Care providers for premature infants (mothers-nurses-Physicians)
Under which criteria data/document could be used
Just to reduce the stress of mothers and in the form of university projects
From where data/document is obtainable
farahani1381@sbmu.ac.ir
What processes are involved for a request to access data/document
About a month
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