Protocol summary

Study aim
Impact of Breast Immunization Program on Premature Infant
Design
The experimental group was a premature infant, admitted in the intensive care unit of Sayyad Shirazi Hospital. The nurses are randomly selected and the intervention and control groups are divided by coin throwing. The total number is 50 . The trial is a type of clinical trial.
Settings and conduct
The place of intervention of the intensive care unit of Sayyad Shirazi Hospital in Gorgan is done by clinical trial. The samples are divided into test and control groups. First, pre test intervention is taken. On the fourth day of admission to the intervention group, the first stage of self-remittance is implemented. Four days later, the implementation of the first stage, the second stage of implementation, is taken in the field of participation in the pre-test. Two days prior to discharge, the test pre-test is also done for attachment.
Participants/Inclusion and exclusion criteria
Reading and writing literacy and aged 18+.   It is directly responsible for the care of the patient. Parents do not have physical and mental disabilities. Premature infants with a baby's age have no problem and no malformations. 26 to 34 weeks and birth weight less than 2500 grams. If they do not want to continue their collaboration, they will be excluded from the study. Two absentee sessions eliminate parents from studying.
Intervention groups
The intervention is carried out in an empowering program and providing information on premature infants in order to increase participation and attachment and increase compliance with the critical situation in the intervention and control group.
Main outcome variables
Parental compatibility with existing conditions Parent company in baby care An attachment to the premature baby was born Take advantage of your potential abilities

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170512033932N6
Registration date: 2019-01-06, 1397/10/16
Registration timing: registered_while_recruiting

Last update: 2019-01-06, 1397/10/16
Update count: 0
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Hosein Motahariniya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3222 4908
Email address
h_hojjati@aliabadiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of empowerment program on participation and attachment of parents with premature infants admitted to neonatal intensive care unit of Sayyad Shirazi Hospital in Gorgan in 1397
Public title
An Empowerment Program on Parents with Preterm Infants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Get informed consent from the company in this study.. Reading and writing materials are over 18 years old . It is the direct responsibility of caring for the patient. Waldin is not physically and mentally handicapped Premature infants admitted at age 26 to 34 weeks and birth weight less than 2500 grams.
Exclusion criteria:
If they do not want to continue their collaboration, they will be excluded from the study Two absentee sessions eliminate parents from studying
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization is done with sealed envelope tools in such a way that the envelopes are written in letters A and B, and the mothers are asked to select an envelope that the group A of the intervention group and the B group will be tested.
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 Committee of Golestan University of Medical Sciences
Street address
Gorgan, Golshahr Square, Golshahr 32, Gorgan
City
Gorgon
Province
Golestan
Postal code
1234
Approval date
2018-08-27, 1397/06/05
Ethics committee reference number
IR.GOUMS.REC.1397.092

Health conditions studied

1

Description of health condition studied
In this study, the effect of parents empowerment on their participation in care and their attachment level is studied
ICD-10 code
ICD-10 Cha
ICD-10 code description
عوامل مؤثر بر سلامت و تماس با خدمات بهداشتی و درمانی

Primary outcomes

1

Description
Parents have premature infants
Timepoint
Before intervention, 4.8 days after intervention and 2 days before discharge
Method of measurement
Avant Attachment Questionnaire and Participation Questionnaire for Parents with Premature Infants

Secondary outcomes

empty

Intervention groups

1

Description
ntervention group: Includes 25 parents with premature infants. After receiving the pre-test, the demographic characteristics, attachment and participation of the parents in the 2-4 days after the admission and 4-4 days after the first stage receive the necessary training for the newborns, and 2 days before the post-discharge post-attachment test And participate.
Category
Behavior

2

Description
Control group: Twenty-five parents with premature infants admitted to the neonatal intensive care unit, on the second day of admission, pre-test, demographic characteristics, attachment and participation were taken without intervention. Two days before the discharge, the post-test was also taken
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sayyad Shirazi Hospital
Full name of responsible person
Hanieh Sajadi
Street address
Golshahr Square, Golshahr Street 32
City
Gorgon
Province
Golestan
Postal code
1234
Phone
+98 17 3322 3131
Email
H_hojjati@aliabadiau.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rouhollah Samii
Street address
Azad University Street, Azad University of Aliabad
City
Ali Abad
Province
Golestan
Postal code
1234
Phone
+98 17 3323 3131
Email
H_hojjati@aliabadiau.ac.ir
Grant name
2000000
Grant code / Reference number
1234
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University of Ali Abad Katoul
Full name of responsible person
Hanieh ُSajadi
Position
Nures
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golshahr Square, Golshahr Street 32
City
Gorgon
Province
Golestan
Postal code
1234
Phone
+98 17 3323 3131
Email
H_hojjati@aliabadiau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hanieh Sajadi
Position
Nures
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golshahr Square, Golshahr Street 32
City
Gorgan
Province
Golestan
Postal code
1234
Phone
+98 17 3323 3131
Email
H_hojjati@aliabadiau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Golbahar Akhondzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mudsar-Golshahr-Golshahr Square 32
City
Gorgon
Province
Golestan
Postal code
1234
Phone
+98 17 3323 3131
Email
G_akhoondzadeh@yahoo.com

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Results and results of the study will be shared
When the data will become available and for how long
Post-print information will be publicly available
To whom data/document is available
All students and researchers can apply for information.
Under which criteria data/document could be used
Use of questionnaires and titles for further studies and studies is allowed.
From where data/document is obtainable
Email haniehsajadi74@gmail.com Message to be sent.
What processes are involved for a request to access data/document
Email request or contact
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