The aim of the study: Effectiveness of partnership educational method on decreasing anxiety and stress in mothers of children with cystic fibrosis. Type of study: This study is a quasi-experimental study with two groups. Research environment: Children’s hospitals affiliated with the Tehran University of Medical Sciences (Children's Medical Center, Valiasr and Bahrami), Shahid Beheshti (Mofid) and Iran (Ali Asghar and Shahid Fahmideh). Research community: All mothers of hospitalized children with Cystic Fibrosis. Sampling : The convenience sampling. Entry criteria: The definitive diagnosis of CF; Able to read and write Persian; Housewife; Absence of congenital anomalies in children; The absence of stressful events in the family, such as having a child who has a serious illness and the married mothers. Exclusion criteria: Unwillingness to participate in research. Sample size: Test and control groups of 44 each. The intervention: In the first day, mothers will sign the informed consent form. Before the intervention, mothers will complete Spielberger anxiety questionnaire, parental stress and demographic information. Mothers will receive a booklet. In the second and third days, mothers will study the booklet and will discuss with each other. In the Seventh day, questionnaires will be completed by the mothers again. The control group will receive the usual medical care. The results of the questionnaires will be compared
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501296316N4
Registration date:2017-01-06, 1395/10/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-06, 1395/10/17
Registrant information
Name
Zahra Daneshvar Ameri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
daneshvz@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Science
Expected recruitment start date
2016-10-21, 1395/07/30
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of partnership educational method on decreasing anxiety and stress in mothers of children with cystic fibrosis
Public title
Clinical trials of Effectiveness of partnership educational method on decreasing anxiety and stress in mothers of children with cystic fibrosis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: The definitive diagnosis of CF; Able to read and write Persian; Housewife; Absence of congenital anomalies in children; The absence of stressful events in the family; such as having a child who has a serious illness; The married mothers.
Exclusion criteria: Unwillingness to participate in research.
Age
From 1 month old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Names are marking and odd numbers will enter in the experimental group and even numbers in the control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical science School of Nursing and Midwifery
Street address
Tehran - tohid Square
City
tehran
Postal code
Approval date
2015-11-03, 1394/08/12
Ethics committee reference number
IR.TUMS.REC.1394.2096
Health conditions studied
1
Description of health condition studied
cystic fibrosis
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis, unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
before and after intervention
Method of measurement
spilberger questionnaire
2
Description
stress
Timepoint
before and after intervention
Method of measurement
Parenting Stress Index—Short Form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In the first day, mothers will sign the informed consent form. Before the intervention, mothers will complete Spielberger anxiety questionnaire, parental stress and demographic information. Mothers will receive a booklet. In the second and third days, mothers will study the booklet and will discuss with each other. In the Seventh day, questionnaires will be completed by the mothers again.
Category
Other
2
Description
Control group: In the first day, mothers will sign the informed consent form. Mothers will complete Spielberger anxiety questionnaire, parental stress and demographic information. The control group will receive the usual medical care. In the Seventh day, questionnaires will be completed by the mothers again.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's hospitals of Tehran University of Medical Science (Children Center, Valiasr and Bahrami h
Full name of responsible person
Soraya Jafari
Street address
Children Medical Center, Valiasr and Bahrami hospitals,Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Children's hospitals of Iran University of Medical Science (Ali Asgar and Shahid Fahmide hospitals)
Full name of responsible person
Soraya Jafari
Street address
Ali asgar and Shahid Fahmide hospitals, Tehran
City
Tehran
3
Recruitment center
Name of recruitment center
Children's hospital of Shahid Beheshti University of Medical Science (Mofid hospital)
Full name of responsible person
Soraya Jafari
Street address
Mofid hospital, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Yunesian
Street address
Building 43, Quds Street, Keshavarz Boulevard, Tehran