The purpose of this study is evaluating the effect of maternal empowerment program on burden of care in mothers of children with PKU and also the Phenylalanine serum level in the suffering children.50 mothers that have inclusion criteria participated in the study in two groups (each group consist of 25 mother). Before intervention the mothers completed the questionnaires. Inclusion criteria for mothers consist of: having children with established diagnosis of Phenylketonuria, living in Qazvin province or its surrounding villages. Exclusion criteria were the family's unwillingness to participation in the research. The intervention based on the family-centered empowerment pattern with 4 steps is conducted during 9 sessions, duration of each is 60 to 90 for mothers. The final evaluation will be taken 1 month after the intervention by using the Zarit burden interview for mothers and evaluating the serum phenylalanine in children in both groups. For considering the research ethical issues, after the final evaluation, 1-2 training sessions were held for control group and pamphlets and booklets were placed at their disposal. The intervention began on July 5th, and ended on September 12th, 2016.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071828975N1
Registration date:2017-04-21, 1396/02/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Tahereh Sojoodi
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences (USWR)
Country
Iran (Islamic Republic of)
Phone
00982833359224, 00982122180036
Email address
tsojodi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Funding source : University of social welfare and rehabilitation sciences es - - Dr. Abolfazl Rahgoui
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2016-11-12, 1395/08/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of maternal empowerment program on burden of care in mothers of children with PKU
Public title
Effect of maternal Empowerment Program on Decreasing the Burden of Caring in mothers of Children with Phenylketonuria and Controlling Phenylalanine (in Children )
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Mothers of children with established diagnosis of Phenylketonuria, living in Qazvin province or its surrounding villages. Exclusion criteria: The family's unwillingness to participation in the research
Age
From 5 days old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
university of social welfare and rehabilitation sciences(USWR)
Street address
kodakyar street- daneshjo blv. - evin
City
Tehran
Postal code
1985713834
Approval date
2016-06-26, 1395/04/06
Ethics committee reference number
IR.USWR.REC.1395.227
Health conditions studied
1
Description of health condition studied
phenylketonuria
ICD-10 code
E70.0
ICD-10 code description
Classical phenylketonuria
Primary outcomes
1
Description
Burden of care
Timepoint
Before and 1 month after intervention
Method of measurement
zarit interview and determining the serum level of phenylalanine
2
Description
Burden of care
Timepoint
Before and 1 month after intervention
Method of measurement
zarit interview and determining the serum level of phenylalanine
Secondary outcomes
1
Description
Laboratory parameters
Timepoint
before intervention -after intervention
Method of measurement
serum level of phenylalanine
2
Description
Laboratory parameters
Timepoint
before intervention -after intervention
Method of measurement
serum level of phenylalanine
3
Description
Laboratory parameters
Timepoint
before intervention -after intervention
Method of measurement
serum level of phenylalanine
4
Description
Laboratory parameters
Timepoint
before intervention -after intervention
Method of measurement
serum level of phenylalanine
Intervention groups
1
Description
Mothers in intervention group participated in family-centered empowerment program in four steps over nine sessions, each session lasting 60-90 minutes twice a week.
Category
Behavior
2
Description
Mothers in control group only received the routine care. After the final evaluation, 1-2 training sessions were held and pamphlets and booklets were placed at their disposal
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
qods hospital
Full name of responsible person
mother
Street address
City
qazvin
2
Recruitment center
Name of recruitment center
qods hospital
Full name of responsible person
Dr. abolfazl rahgoi
Street address
University of social welfare and rehabilitation science(USWR)
City
Kodakyar street- daneshjo blv.evin- tehan
3
Recruitment center
Name of recruitment center
qods hospital
Full name of responsible person
Dr. abolfazl rahgoi
Street address
qazvin Iran, Islamic Republic of
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
univerUniversity of social welfare and rehabilitation sciences(USWR)
Full name of responsible person
Dr. abolfazl rahgoi
Street address
kodakyar street - daneshjo blv. - evin - tehran Tehran Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
univerUniversity of social welfare and rehabilitation sciences(USWR)
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
university of social welfare and rehabilitation science(USWR)
Full name of responsible person
Dr. abolfazl rahgoi
Position
PhD
Other areas of specialty/work
Street address
kodakyar street - daneshjo blv. - evin - tehran
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
+98 21 2218 0036
Email
rahgouin@yahoo.com
ab.rahgoi@uswr.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
university of social welfare and rehabilitation sciences(USWR)
Full name of responsible person
Dr. abolfazl rahgoi
Position
PhD
Other areas of specialty/work
Street address
kodakyar street - daneshjo blv. - evin - tehran
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
+98 21 2218 0036
Email
rahgouin@yahoo.com
ab.rahgoi@uswr.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
university of social welfare and rehabilitation sciences(USWR)
Full name of responsible person
Dr. abolfazl rahgoi
Position
PhD
Other areas of specialty/work
Street address
kodakyar street - daneshjo blv. - evin - tehran
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
rahgouin@yahoo.comAb.rahgoi@uswr.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)