This study was implemented in form of a randomized experimental design over 100 parents with premature infants in Mostfakhomeini and Imamkhomeini hospitasl, Ilam, Iran. In order to avoid exchanging information between the two groups, first, control group was randomly assigned. sample selection was stopped for three weeks till mothers participating in the study were discharged from the hospital. Then participants for experimental group were selected.. Treatment included four stages: Stage 1: 2 to 4 days after infant hospitalization Stage2: 2 to 4 days after the first stage Stage3: 1 to 3 days before discharging Stage 4: 1 week after discharging In every stage, in the absence of the researcher, the mother listened to an audio file containing information regarding that stage, for 15 minutes. At the same time this information was provided for the mother in the form of a booklet to use during the time of listening. Also, there was a workbook related to that stage at the end of every booklet and parents was required to complete. The completed version was provided for the research.The length of stay and readmission rate in the two groups were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090329654N1
Registration date:2017-06-21, 1396/03/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-21, 1396/03/31
Registrant information
Name
Zahra Poornajaf
Name of organization / entity
Midwifery&Nursing Faculty The International Branch of Shahid Beheshti University of Medical Sicences
Country
Iran (Islamic Republic of)
Phone
+98 84 3223 0047
Email address
zahrapoornajaf@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-10-06, 1395/07/15
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effects of creating opportunities for parents empowerment on length of stay and readmission of preterm infants
Public title
Parents empowerment effect on readmission and length of stay of preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Parents inclusion criteria: biological parents, older than 18 years, ability to write and read, no physical or psycological disorder based on self report and recorded data. Infants inclusion criteria: gestational age between 26-34 weeks, birth weight less than 2500 grams, singleton pregnancy, no congenital abnormality
Exclusion criteria: Discharge before the end of the program, infant death, absence of parents for more than 4 days.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Parental Empowerment Program (COPE) a educational-behavioural intervention based on the theory of self-regulation and Control is designed by Melyk, in 2001 for parents parents of premature infants
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of The International Branch of Shahid Beheshti University of Medical Sciences
Street address
19 Shahid Abbasspour St، Vali-Asr Ave، Tehran
City
Tehran
Postal code
14155-3693
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.112
Health conditions studied
1
Description of health condition studied
Preterm infant
ICD-10 code
po7.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
Length of stay
Timepoint
The wole of hospitalization from admission to discharge
Method of measurement
Day
2
Description
Readmision
Timepoint
One month after discharge
Method of measurement
call contact with parents
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group:Educatinal-behavioral empowerment program was performed in 4 stages:2-4 days after admission(stage one) 2-4 days after completing the first stage(stage two) 2-4 days after stage two and one week after discharge (stage four).
Category
Behavior
2
Description
Control group: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini Hospital
Full name of responsible person
Zahra Poornajaf
Street address
Shahid Keshvari Sq., Modarress Blv,Ilam-Iran
City
Ilam
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Maryam Karami
Street address
Ayatollah Heidari Ave.,Ilam-Iran
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Zahra Poornajaf
Street address
Abedin Alley، Salehin St، Azadi Blvd، Ilam
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
The International Branch of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra poornajaf
Position
NICU Ms Student
Other areas of specialty/work
Street address
Abedin Alley، Salehin St، Azadi Blvd، Ilam
City
Ilam
Postal code
Phone
+98 84 3223 0047
Fax
Email
ZAHRAPOORNAJAF@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Midwifery&Nursing Faculty of Shahid Beheshti
Full name of responsible person
Fatemeh Alaee Korahroudi
Position
Phd
Other areas of specialty/work
Street address
Vali-Asr Ave, First of Niayesh Highway, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5372
Fax
Email
fatemeha@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The Internatinal Branch of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Poornajaf
Position
NICU Ms Student
Other areas of specialty/work
Street address
Abedin Alley, Salehin St, Azadi Blvd
City
Ilam
Postal code
Phone
+98 84 3223 0047
Fax
Email
zahrapoornajaf@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)