Protocol summary

Summary
This study will be done to investigate the effectiveness of discharge planning by nurse on the ability of parents of premature infants admitted to the neonatal intensive care unit of selected hospital of medical sciences of Isfahan in 2015. This is non-blinded clinical trial. The study population will be parents (father or mother) of preterm infants admitted to the neonatal intensive care unit of Beheshti hospital in Isfahan. That 64 persons are selected and randomly will be assigned to two experimental and control groups. Training will be conducted in three stages. In the first stage, training will be started by nurse for 15 minutes individually based on the parent need and infant problem from the third day of hospitalization. In the second stage, group training, according to the ministry of health protocol during 14 sessions (30 minutes each session) will be performed and in the third stage training will be performed before discharge for 15 minutes. The control group will not receive any training, then checklists will be completed during admission for premature infants (one week after the start of training), at the time of discharge from the hospital and the third to seventh day after discharge in both the experimental and control groups and variables of routine care, specialty care, optimum ability, relatively desirable ability, and undesirable abilities will be examined. Inclusion criteria: informed consent of the parents; no history of psychotropic and anti-anxiety drugs; do not having a diagnosis of mental retardation, blindness, deafness; mothers pregnancy age less than 37 weeks. Exclusion criteria were: discharge or death of the baby before completion of the training program; transfer the baby to the other ward or hospital.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015051722297N1
Registration date: 2016-02-07, 1394/11/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-07, 1394/11/18
Registrant information
Name
Leila Amirani
Name of organization / entity
Esfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 163 5424
Email address
leila.amirani92@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences
Expected recruitment start date
2016-01-30, 1394/11/10
Expected recruitment end date
2016-05-30, 1395/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of discharge planning by nurse on the ability of parents of premature infants admitted to the neonatal intensive care unit of selected hospital of medical sciences of Isfahan in 2015
Public title
Investigation the effectiveness of discharge planning by nurse on the ability of parents of premature infants.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: informed consent of the parents; no history of psychotropic and anti-anxiety drugs; do not having a diagnosis of mental retardation, blindness, deafness; mothers pregnancy age less than 37 weeks. Exclusion criteria were: discharge or death of the baby before completion of the training program; transfer the baby to the other ward or hospital.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly by tossing coins

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Approval date
2015-08-30, 1394/06/08
Ethics committee reference number
Ir.mui.rec.1394.3.411

Health conditions studied

1

Description of health condition studied
Parents training of neonantal
ICD-10 code
z76.3
ICD-10 code description
Healthy person accompanying sick person

Primary outcomes

1

Description
Ordinary ability
Timepoint
Baseline, 1 week after starting intervention, during the discharge, and three days after discharge
Method of measurement
checklist

2

Description
Specific abilities
Timepoint
Baseline, 1 week after starting intervention, during the discharge, and three days after discharge
Method of measurement
checklist

Secondary outcomes

empty

Intervention groups

1

Description
In the experimental group from the beginning of admission until the third day of hospitalization, checklists will be completed then training according to the Ministry of Health protocol from third day of hospitalization in three stages will start .In the first stage from the third day of hospitalization training will start by nurse for 15 minutes individually based on the parent need and child problem. In the second stage, group training, in14 sessions (30 minutes each session) will be performed and in the third stage training will be performed before discharge for 15 minutes. after each training session pamphlets and booklets for parents is also provided. then checklists according to items trained on the during admission of infants will be completed during admission (one week after the start of training), at the time of discharge from the hospital and the third to seventh day after discharge and variables of routine care, specialty care, optimum ability, relatively desirable ability, and undesirable abilities will be examined
Category
Behavior

2

Description
In the control group from the beginning of admission until the third day of hospitalization, checklists will be completed, but will not receive any training. then checklists according to items trained on the during admission of infants will be completed during admission (one week after the start of training), at the time of discharge from the hospital and the third to seventh day after discharge and variables of routine care, specialty care, optimum ability, relatively desirable ability, and undesirable abilities will be examined
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid beheshti hospital
Full name of responsible person
Leila Amirani
Street address
Shahid beheshti hospital, Steel bridge
City
Esfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mahdi Nematbakhsh
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Esfahan 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
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Amirani
Position
Student of Ms. Nursing of Emergency care
Other areas of specialty/work
Street address
School of Nursing & Midwifery,Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Phone
+98 31 5422 9774
Fax
Email
Leila.amirani92@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mahbobeh Namnabati
Position
PhD in Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Phone
+98 31 3792 2906
Fax
Email
namnabat@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Amirani
Position
Student of Ms. Nursing of Emergency care of infant
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Phone
00
Fax
Email
Leila.amirani92@gmail.com
Web page address

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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