Determining the effect of training on depression, anxiety and stress in mothers with phenylketonuria child
Design
Experimental study with control group with parallel and one-blind groups
Settings and conduct
Among the mothers with phenylketonuria child referring to the phenylketonuria clinic of Ahvaz's children's hospital in Abouzar, the mothers who are willing to participate in the research and who meet the criteria for entry, sampling was done in an accessible manner and then by random allocation of units The research is done in two groups: intervention and control.
Participants/Inclusion and exclusion criteria
Only mothers are allowed to enter the study, that children having phenylketonuria and willing to participate in the study And refer to the Phenylketonuria Association.
Intervention groups
For the intervention group, a 5-session class on Wednesday, every week, and every 1 hour and ten minutes for each session, the intervention group will first have a lecture and then a Q & A session, and at the end of each session, mothers will raise their concerns about the affected child. At the end of the sessions, an educational package containing an overview of the training given will be provided to the intervention sample. Immediately after training and 4 weeks after the completion of the training, the mothers of the intervention group will be interviewed and their anxiety will be measured by a questionnaire for the second and third times. The content of these training sessions will be in 5 sections.
At the end of the study, in order to observe the ethics in the research, the content of the training will be provided to the control group and, if desired, individual training will be given.
Main outcome variables
The effect of education on stress, anxiety and depression in mothers with phenylketonuria child
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181013041324N1
Registration date:2018-12-05, 1397/09/14
Registration timing:registered_while_recruiting
Last update:2018-12-05, 1397/09/14
Update count:0
Registration date
2018-12-05, 1397/09/14
Registrant information
Name
Forouzan Khodabakhshi Ardali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 0888
Email address
khodabakhshi.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-16, 1397/07/24
Expected recruitment end date
2019-01-04, 1397/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of training on depression, anxiety and stress in mothers with phenylketonuria child
Public title
Effect of training on depression, anxiety and stress in mothers with phenylketonuria child
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The mother has the main role of keeping the child affected.
The person caring for the patient should not have a history of phenylketonuria.
Mother is not a member of the health professional team.
The mother has not participated in a class or any kind of special education for the disabled child.
Mother has no tense experiences in the last 3 months
The mother has no known mental illness and does not use sedative medications
Parents do not have addiction.
Parents are not exposed to the process of separation
The mother of the child is married and lives with her husband
The mother has no chronic long-term illness.
The age of the affected child is 9 years or less.
The child has a classical phenylketonuria disease
3 to 6 months from the diagnosis of the disease.
Exclusion criteria:
Mothers who are not willing to enter the study.
Mothers who are being treated with anti-anxiety drugs.
Mothers who have anxiety disorders.
Mothers who are being treated with anti-depressant drugs.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Among the mothers with phenylketonuria child referring to the phenylketonuria clinic of Ahvaz's children's hospital in Abouzar, the mothers who are willing to participate in the research and who meet the criteria for entry, sampling was done in an accessible manner and then by random allocation of units The research is done in two groups: intervention and control. the sample size is 74 people. They were selected by available sampling method and randomly divided into two groups: intervention and control (37 cases, 37 controls); we have a list of patients' names and Calling the mothers with the affected patient. To prevent contamination between the two intervention and control groups, allocation of research units to the two groups will be in the form of a timetable and through a lottery (throwing coins). In order to prevent information exchange, first the control group will complete the demo questionnaire and the DASS 21 questionnaire immediately and one month later.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, we have two groups of intervention and control that none of the participating groups will know which intervention is, and which is the control group, and is in fact a blind one.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat West Highway, between intersection of Sheikh Fazlollah Noori and Shahid Chamran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-08-25, 1397/06/03
Ethics committee reference number
IR.IUMS.REC.1397.266
Health conditions studied
1
Description of health condition studied
Effect of training on depression, anxiety and stress in children with phenylketonuria
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety and Stress Scale in questionnaire Depression Anxiety Stress Scale 21
Timepoint
Measure the stress score, depression and anxiety before the intervention, immediately after training and four weeks after completion of the training.
Method of measurement
Questionnaire Depression Anxiety Stress Scale 21
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, a 5-session class on Wednesday, every week, and every 1 hour and ten minutes for each session, the intervention group will first have a lecture and then a Q & A session, and at the end of each session, mothers will raise their concerns about the affected child. At the end of the sessions, an educational package containing an overview of the training given will be provided to the intervention sample. Immediately after training and 4 weeks after the completion of the training, the mothers of the intervention group will be interviewed and their anxiety will be measured by a questionnaire for the second and third times. The content of these training sessions will be in 5 sections
Category
N/A
2
Description
Control group: There will be no training in the control group. At the end of the study, in order to observe the ethics in the research, the content of the training will be provided to the control group and, if desired, individual training will be given.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Abuzar hospital
Full name of responsible person
Forouzan Khodabakhshi Ardali
Street address
unit 6, floor 2, building Arg2, Day st, Ordibehesht st, Farvardin st, Golestan
City
ahvaz
Province
Khouzestan
Postal code
6136765118
Phone
+98 61 3222 0888
Email
forouzanmidwifer.1367@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Kazem Malakouti
Street address
Hemmat West, between Sheikh Fazlollah Noori and Shahid Chamran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8831 7137
Email
forouzanmidwifer.1367@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Neisani Samani
Position
Instructor-faculty of the university
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
West Hamو Between Sheikh Fazlollah Nouri and Shahid Chamran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 4465 2302
Email
Neisani89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Neisani Samani
Position
Instructor-faculty of the university
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
West Hamو Between Sheikh Fazlollah Nouri and Shahid Chamran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 4465 2302
Email
Neisani89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Forouzan Khodabakhshi Ardali
Position
Master of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 6, floor 2, bulding arg 2, day st, farvardin st, golestan, ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6136765118
Phone
+98 61 3222 0888
Fax
Email
forouzanmidwifer.1367@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available