Protocol summary

Summary
The aim of discharge planning , preparing families for the care of premature infants at home after discharge.a randomized controlled trial study was conducted on 92 mothers of preterm infants (gestational age: 320/ 7 -366/7 weeks) in neonatal ICU of Tabriz Alzahra hospital in 2013.Inclusion criteria such as:infants without congenital anomalies; Apgar score of 5 minute after birth was 7. 92 mothers participated in the study were divided into two groups intervention and control , and randomly selected , two groups have not been in touch and exchange information .All of mothers at once after admitted, fill demographic Questionnaire and parental stress scale (berry) and Parental satisfaction questionnaire. after admitted, discharge planning program was done for intervention group and mothers of control group received routine and usual cares. Maternal stress and satisfaction was measured in both admission and discharge time in two groups by using Parental stress scale (berry) and Parental satisfaction questionnaire .In both groups were evaluated separately.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015050313691N2
Registration date: 2015-05-19, 1394/02/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-05-19, 1394/02/29
Registrant information
Name
Mohammad Arshadi Bostanabad
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
arshadi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz Medical Sciences University
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of discharge planning program on stress and satisfaction of preterm infant mothers in NICU Randomized control Trial
Public title
effect of discharge planning program on stress and satisfaction of preterm infant mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : birth age between 32/07_36/67 weeks; birth weight more than 1300 g;Apgar score of 5 minute after birth was 7 ; infants without congenital anomalies or syndromes ;having a singleton; the first child in the family; the mother is ready to cooperate and literacy ;The mother has not history of mental disease or the mother has a history of substance abuse. Exclusion criteria : hospitalization for more than two weeks or less than two days;serious illness of newborn; the baby dies; the mother is one of the medical personnel; the absence of the mother in one of the meetings; precious baby born to seeking mother infertility.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
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
Tabriz University of Medical Sciences
Street address
South Sharyati Ave.-
City
Tabriz
Postal code
5138947977
Approval date
2013-10-02, 1392/07/10
Ethics committee reference number
5/4/5582

Health conditions studied

1

Description of health condition studied
stress
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder

Primary outcomes

1

Description
stress
Timepoint
before Intervention,Time Discharge
Method of measurement
Parental stress scale,Berry

2

Description
satisfaction
Timepoint
before Intervention,Time Discharge
Method of measurement
Parental satisfaction questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
After admision and pre-intervention, The intervention group completed parental stress scale and parental Satisfaction Questionnaire. intervention group received discharge planning program. It Includes two one-hour sessions consisted of 5 mothers with lectures, training manual and videotape training package of discharge planning included nutritional care, prevention and management of infections, evaluate hyperbilirubinemia and body temperature, cognitive symptoms (cognitive and disease management at home and criteria for referr to a doctor) ,vaccination, hearing evaluation and follow-up examinations, eye, respiratory cardiopulmonary resuscitation training, instructions bathing, prevention of violence and the prevention of dermatitis baby is shaken baby syndrome. The first training session of discharge (breastfeeding education and prevention of hypothermia, bathroom and care eyes, navel) in the first few days of the admitted of the baby and the second session before discharge(cardiopulmonary resuscitation and respiratory medication). educational books(recognizing symptoms and infant safety, follow-up vaccination and screening) were distributed between two meetings. Discharge time, parent stress scale (berry) and parental satisfaction questionnaire, were distributed and evaluated .
Category
Other

2

Description
After admitted,control group completed parental stress scale (berry) and parental satisfaction questionnaire .control group received routine program.In discharge time ,the parental stress scale (berry) and parental satisfaction questionnaire were distributed and evaluated.When discharge,educational books were distributed in control group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Alzahra hospital
Full name of responsible person
Soeibeh seyedi elmabad
Street address
South Artesh Ave.Crossroads Baghshmal.Alzahra hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Shakouri
Street address
Tabriz University of Medical Sciences- Daneshgah Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arshadi Bostanabad Mohammad
Position
PhD Student
Other areas of specialty/work
Street address
South Sharyati Ave. Tabriz
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
arshadi@tbzmed.ac.irarshadi_m@yahoo.com
Web page address

Person responsible for updating data

Contact

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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