Protocol summary

Summary
The purpose of this study is evaluation the effect of parents education in verbal and non-verbal methods to control the amount of phenylalanine of the serum of children which suffering from phenylketonuria. The study population is 45 family and children which suffering from phenylketonuria with 1-18 years old in which referred to PKU clinic of Abuzar hospital. Inclusion criteria: Having a sick child that stricken to PKU; having a file at PKU clinic of Abuzar hospital; Pediatric patient ranging from 1 to 18 years old; The parents learning ability; Having the main care provider at home. Exclusion criteria: absence of parents for at least two training sessions. First, parents by completing questionnaires ,their knowledge about phenylketonuria ,in which has been finalized by professors of university of medical sciences, assessing their awareness of the phenylketonuria (PKU), and according to their scores, randomly they will be divided into two groups , intervention and control. The intervention group contains two group, 15 each, one group using verbal method within 8 sessions , 2 hours each, within one month; and the other group at the same period using non-verbal training method with booklet and pamphlets for one month and follow up, will be trained, The control group consisted of 15 member in which there is no intervention for this group. The Parents of both intervention and control groups after one month will fill up the knowledge questionnaires and their children phenylalanine level, before and after the intervention will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012122911923N1
Registration date: 2013-01-31, 1391/11/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-31, 1391/11/12
Registrant information
Name
Akram Hematipour
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8302
Email address
hematipour.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences.
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the influence of verbal and non-verbal methods of parent education on the control of blood phenylalanine levels in children with phenylketonuria (PKU)
Public title
Comparison the influence of verbal and non-verbal methods of parent education on the control of blood phenylalanine levels in children with phenylketonuria (PKU)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having a sick child that stricken to PKU; having a file at PKU clinic of Abuzar hospital; Pediatric patient ranging from 1 to 18 years old; The parents learning ability; Having the main care provider at home. Exclusion criteria: absence of parents for at least two training sessions.
Age
From 1 year old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ahvaz University of Medical Sciences
Street address
Esfand Alley, Golestan Blvd, Ahvaz, Khuzestan
City
Ahvaz
Postal code
Approval date
2012-06-26, 1391/04/06
Ethics committee reference number
u-91129

Health conditions studied

1

Description of health condition studied
Disease, phenylketonuria (PKU)
ICD-10 code
E70
ICD-10 code description
Disorders of aromatic amino-acid metabolism

Primary outcomes

1

Description
Serum phenylalanine levels
Timepoint
A month before the intervention, one month after intervention
Method of measurement
Blood Tests

2

Description
Parental awareness
Timepoint
A month before the intervention, one month after intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group: personal training (face and speech), two two-hour sessions in a week for 4 weeks
Category
Treatment - Drugs

2

Description
no intervention
Category
Treatment - Drugs

3

Description
The intervention group: in-person training (training manuals and pamphlets) for a period of one month, every week, and follow up by phone
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
PKU clinic in Abuzar hospital
Full name of responsible person
Doctor Aminzadeh Majid, Endocrinology and Metabolism PKU clinics and hospitals charge Abuzar
Street address
Abuzar Hospital, Ahvaz, Khuzestan.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahvaz University of Medical Sciences
Street address
Esfand Alley, Golestan Blvd, Ahvaz, Khuzestan
City
Ahvaz
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
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
Ahvaz University of Medical Sciences
Full name of responsible person
Akram Hemmati pour
Position
Senior Nursing Student Orientation Pediatrics, Ahvaz University of Medical Sciences, School of Nursi
Other areas of specialty/work
Street address
Esfand Alley, Golestan Blvd, Ahvaz, Khuzestan
City
Ahvaz
Postal code
Phone
no
Fax
Email
AkramHematipour@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hoshang Alijani
Position
Pediatric Nursing Department Orientation and Board Member of Ahvaz University of Medical Sciences
Other areas of specialty/work
Street address
Esfand Alley, Golestan Blvd, Ahvaz, Khuzestan
City
Ahvaz
Postal code
Phone
+98 61 1373 8394
Fax
Email
AkramHematipour@yahoo.com, Alijani_Hosh@yahoo.com، Aminzadeh Majid@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Akram Hemmati pour
Position
Senior Nursing Student of children Orientation, Ahwaz University of Medical Sciences, School of Nurs
Other areas of specialty/work
Street address
Esfand Alley, Golestan Blvd, Ahvaz, Khuzestan
City
Ahvaz
Postal code
Phone
Fax
Email
AkramHematipour@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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