Protocol summary
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Study aim
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Determining the effectiveness of clinical guidelines on the care performance of mothers with children with cystic fibrosis
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Design
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A clinical trial including a control group, with parallel groups, sampling will be done with a non-probability sequential method, the samples will be randomly divided into two test groups (N=28) and control (N=28) using the randomized permutation method.
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Settings and conduct
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Place of study: Departments of Abuzar Teaching Hospital, affiliated to Jundi Shapur University of Medical Sciences, Ahvaz; Study population: 56 mothers with hospitalized children with cystic fibrosis who referred to the place of study,Type of blinding: Blinding is not done in this study
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Mothers with children hospitalized with cystic fibrosis in the children's department; Mothers who have the mental capacity to participate in the training course and apply the care instructions; Children between the age group of 3 to 12 years; The duration of the disease is 1 month; The ability of the child to participate in the research. Exclusion criteria: Mothers who have participated in a study before (currently); The child suffering from acute or chronic physical or mental diseases other than cystic fibrosis.
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Intervention groups
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Intervention group: Educational intervention in a combined form (face-to-face and showing an educational video approved by the doctor) will be implemented by the researcher during 6 sessions of 40 minutes (1 session per week) to familiarize the mothers with Clinical guidelines. These instructions are based on the latest articles and using books in this field. Control group: no educational intervention will be done.
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Main outcome variables
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Caring function of Cystic fibrosis
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240501061617N1
Registration date:
2024-06-02, 1403/03/13
Registration timing:
prospective
Last update:
2024-06-11, 1403/03/22
Update count:
1
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Registration date
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2024-06-02, 1403/03/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-06-09, 1403/03/20
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Expected recruitment end date
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2024-07-21, 1403/04/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effectiveness of implementing clinical practice guideline on the care performance of mothers with children with cystic fibrosis
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Public title
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The effect of clinical guidelines on the care performance of mothers with children with cystic fibrosis
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Mothers with children hospitalized with cystic fibrosis in the children's department
Mothers who have the mental capacity to participate in the training course and apply the care instructions
Children between the age group of 3 to 12 years
The duration of the disease is 1 month
The ability of the child to participate in the research according to the severity of the disease with the approval of a specialist doctor
Exclusion criteria:
Mothers who have participated in a study before (currently).
The child suffering from acute or chronic physical or mental diseases other than cystic fibrosis
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Age
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From 3 years old to 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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First, the samples are selected from the research population based on the entry and exit criteria and then randomly assigned to two test groups (28) and control group (28) using blocks.
generally,14 blocks are formed and the samples are randomly assigned to one of the test and control groups through blocks of 4. Symbol A is assigned to the test group and symbol B is assigned to the control group. The list of groups states is prepared in 6 states and numbers 1 to 6 are assigned to them. AABB(1), ABAB(2), ABBA(3), BBAA(4), BABA(5), BAAB(6) then the numbers 1 to 6 are chosen randomly (lottery/person outside the study) and the list of participants is created based on the selected blocks. Sample allocation is done in the control and test groups at the same time.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-04-29, 1403/02/10
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Ethics committee reference number
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IR.AJUMS.REC.1403.031
Health conditions studied
1
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Description of health condition studied
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cystic fibrosis
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ICD-10 code
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E84.9
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ICD-10 code description
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Cystic fibrosis, unspecified
Primary outcomes
1
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Description
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Caring function of cystic fibrosis
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Timepoint
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Before the start of the intervention and two months after the intervention
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Method of measurement
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Researcher-made questionnaire
Intervention groups
1
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Description
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Intervention group: in the test group, for parent training, combined training sessions (face-to-face and educational video showing) about cystic fibrosis disease, treatment and general care and nursing care by the researcher during 6 sessions of 40 minutes (weekly 1 session) will be implemented, in which parents will be divided into groups of 8 people.Also, at the end of the training sessions, educational pamphlets will be provided to them.
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Category
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Behavior
2
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Description
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Control group: In the control group, no educational intervention will be done, but in order to comply with ethical considerations, the educational pamphlet will be delivered to the control group after analyzing the results.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available