Protocol summary

Summary
This research is a semi - experimental study that determines the effect of family-centered care on the level of satisfying parents' needs on hospitalized children. The research site is the Pediatric ward of pediatrics medical training center in Rasht and the research population is mothers of hospitalized 1 to 3-year-old children suffering from UTI. Children with a history of hospitalization will be excluded. Sequential sampling is used each group is estimated to contain 35 subjects. The testimonial papers together with research objective were given to Case and Control groups. For control group, the ward routines care and for case group family-centered care protocol performed. Questionnaire will be completed by co-researcher pre and 48 hours after intervention. Questionnaire with 36 items is consisted of six areas of parent's needs including: needs to support and guidance, consultation, mutual confidence, obtaining information, comfort, convenience, communicating, and needs related to spouse and other family members.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010625843N2
Registration date: 2016-04-09, 1395/01/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-09, 1395/01/21
Registrant information
Name
Hajar Sadeghi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
haj.sadeghi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-02-22, 1393/12/03
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered care and the needs of the anxiety parents of children with urinary tract infection
Public title
Family-centered care compared with usual care in reducing anxiety prevalent in parts of the hospital and meet the needs of patients and their families
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: only Children 1 to 3 years; To be suffering from UTI; Carer is the mother only; Mother has literacy to reading and writting. Exclusion criteria: Children with a history of hospitalization.
Age
From 1 year old to 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The randomization is based on the table of random numbers.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak, Sardasht, Saculty of nursing and midwifery, Arak University of Medical Science
City
Arak
Postal code
Approval date
2015-02-20, 1393/12/01
Ethics committee reference number
93-169-17

Health conditions studied

1

Description of health condition studied
Urinary tract infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified

Primary outcomes

1

Description
Anxiety and parental needs of hospitalized children
Timepoint
Befor and 48 hours after intervention
Method of measurement
kristjansdottir standard questionnaireو Spielberger

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For intervention group a family-centered care protocol are carried out which is prepared with the contribution of researcher, co-researcher and families as well as reviewing related books and articles. Before intervention, and after proper communication with the child, necessary information on care during hospital stay and after discharge is provided by nurses. Purpose of partnership in child care includes: feeding, clothes and diapers changing, taking axillary temperature, controlling intake and output, cleaning child buttocks, changing sheet and arranging child environment, and giving oral medications.
Category
Other

2

Description
Control group: Control group receive routine cares.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Hajar Sadeghi
Street address
Arak, Nurse Sq, Alamolhoda St, Amir kabir Hospital
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Rafiee
Street address
Arak, Rahahan Sq, Alamolhoda St, Arak University of Medical Sciences
City
arak
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 of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hajar Sadeghi
Position
MSC
Other areas of specialty/work
Street address
Arak, Sardasht, Saculty of nursing and midwifery, Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
+98 86 3417 3503
Email
haj.sadeghi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hajar Sadeghi
Position
MSC
Other areas of specialty/work
Street address
Arak, Sardasht, Saculty of nursing and midwifery, Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
+98 86 3417 3503
Email
haj.sadeghi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hajar Sadeghi
Position
MSC
Other areas of specialty/work
Street address
Arak, Sardasht, Saculty of nursing and midwifery, Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
+98 86 3417 3503
Email
haj.sadeghi@yahoo.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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