Determination the effect of implementation of the discharge planning on the satisfaction of mothers and the readmission of hospitalized premature infants
Design
A randomized controlled trial study was conducted on 56 mothers of preterm infants.Simple randomization. Not blinded and parallel.between October 2018 and November 2018.
Settings and conduct
The research environment in this study is the neonatal department or NICU of Khorramshahr Valiasr hospital . From the research community, people will be selected. The samples are divided into two groups of control (28 people) and intervention (28 people). Then, parents' satisfaction evaluate with parental satisfaction questionnaire before and after intervention will evaluate, and one month after discharge, the condition of the newborn's readmission will be Follow up by phone call with parents.
Participants/Inclusion and exclusion criteria
Inclusion criteria : birth age between 32-36 weeks; Apgar score of 5 minute after birth was more than 7 ; infants without congenital anomalies or syndromes; The mother has not history of mental disease or the mother has not a history of substance abuse.
Exclusion criteria :Newborn with cardiopulmonary resuscitation. Mother is a member of the University of Medical Sciences
Intervention groups
Implementation of discharge planning for the intervention group from the time of admission and the day of discharge ( in two session ).
Each training session is individual and one-hour with practical , teaching-lecture and booklet ( educational package ).
The first training session will be on the second day of admission and the second training session on the day of discharge.
The control group recieves routine training ( include lactation, infection control, follow up screening program ) of the department.
Main outcome variables
Readmission; Satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181215041983N1
Registration date:2020-02-08, 1398/11/19
Registration timing:retrospective
Last update:2020-02-08, 1398/11/19
Update count:0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Alieh Afsharnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5353 1442
Email address
a.afsharnia@abadanums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-19, 1397/08/28
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of implementation of the discharge planning on the satisfaction of mothers and the readmission of hospitalized premature infants
Public title
The effect of the implementation of the discharge plan on the satisfaction of mothers and the re-admission of premature infants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Newborn age between 32-36 week of gestational age
Apgar score of 5 minute > 7
Without congenital anomaly or syndromes
Mother preparation for cooperation
To be able read and write
The mother has not history of mental disease or substance abuse
Exclusion criteria:
Newborn with cardiopulmonary resuscitation
Mother is a member of the University of Medical Sciences
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study was performed by simple randomization method.The randomization tool was flip of the coin.
Coins were thrown until the sample size was reached.
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
Ethics committe of Ahwaz University of Medical Sciences
Street address
Ahwaz University of Medical Sciences, No. 7, West Golestan Ave,Golestan Highway, Ahvaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6193673111
Approval date
2018-11-17, 1397/08/26
Ethics committee reference number
IR.AJUMS.REC.1397.617
Health conditions studied
1
Description of health condition studied
Prematurity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Satisfaction score in parental satisfaction questionnaire
Timepoint
Before the intervention and the day of discharge (after the intervention),
Method of measurement
Parental satisfaction questionnaire
2
Description
Readmission
Timepoint
One month after discharge
Method of measurement
Call
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Implementation of discharge planning for the intervention group from the time of admission and the day of discharge ( in two session ), each training session is individual and one-hour with practical, teaching-lecture and booklet ( educational package ). The first training session will be on the second day of admission and the second training session on the day of discharge.
Category
Other
2
Description
Control group: receive routine program.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Alieh Afsharnia
Street address
Valiasr Hospital,Water Organization Blvd.
City
Khorramshahr
Province
Khouzestan
Postal code
6418733891
Phone
+98 61 5354 4804
Fax
+98 61 5354 0067
Email
Bmvakh@gmail.com
Web page address
https://abadanums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Ahwaz University of Medical Sciences, No. 7, West Golestan Ave,Golestan Highway, Ahvaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3373 8395
Fax
+98 61 3373 8395
Email
badavim@yahoo.com
Web page address
http://ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Shahnaz Rostami
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Midwifery Factulty, Ahwaz University of Medical Sciences, No. 7, West Golestan Ave,Golestan Highway, Ahvaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3373 8396
Fax
+98 61 5354 0067
Email
shahnazrostami2014@gmail.com
Web page address
http://ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahnaz Rostami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahwaz University of Medical Sciences, No. 7, West Golestan Ave,Golestan Highway, Ahvaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6418733891
Phone
+98 61 3373 8396
Fax
+98 61 3373 8396
Email
Rostami-sh@ajums.ac.ir
Web page address
http://ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahnaz Rostami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahwaz University of Medical Sciences, No. 7, West Golestan Ave,Golestan Highway, Ahvaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6418733891
Phone
+98 61 3373 8396
Fax
+98 61 3373 8396
Email
Rostami-sh@ajums.ac.ir
Web page address
http://ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available