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Recruitment centers
#1
Name of recruitment center - English: Abozar Hospital
Name of recruitment center - Persian: بیمارستان ابوذر
Full name of responsible person - English: Ashraf al-Sadat Hakim
Full name of responsible person - Persian: اشرف السادات حکیم
Street address - English: Ahvaz, Zaytoun Karmanani, Pasdaran Blvd., Nurse St., Abu Dhar Children's Educational and Therapeutic Hospital
Street address - Persian: اهواز، زیتون کارمندی، بلوار پاسداران، خیابان پرستار، بیمارستان آموزشی درمانی کودکان ابوذر
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6163614175
Phone: +98 61 3444 9003
Fax:
Email: aboozar-hos@ajums.ac.ir
Web page address:
Name of recruitment center - English: Abozar Hospital
Name of recruitment center - Persian: بیمارستان ابوذر
Full name of responsible person - English: Ashrafalsadat Hakim
Full name of responsible person - Persian: اشرف السادات حکیم
Street address - English: Abozar Children's Educational and Therapeutic Hospital, Parastar street, Pasdaran boulevard, Zeyton Karmandi, Ahvaz
Street address - Persian: اهواز، زیتون کارمندی، بلوار پاسداران، خیابان پرستار، بیمارستان آموزشی درمانی کودکان ابوذر
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6163614175
Phone: +98 61 3444 9003
Fax:
Email: aboozar-hos@ajums.ac.ir
Web page address:
Name of recruitment center - English: Abozar Hospital Name of recruitment center - Persian: بیمارستان ابوذر Full name of responsible person - English: Ashraf al-SadatAshrafalsadat Hakim Full name of responsible person - Persian: اشرف السادات حکیم Street address - English: Ahvaz, Zaytoun Karmanani, Pasdaran Blvd., Nurse St., Abu DharAbozar Children's Educational and Therapeutic Hospital, Parastar street, Pasdaran boulevard, Zeyton Karmandi, Ahvaz Street address - Persian: اهواز، زیتون کارمندی، بلوار پاسداران، خیابان پرستار، بیمارستان آموزشی درمانی کودکان ابوذر City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6163614175 Phone: +98 61 3444 9003 Fax: Email: aboozar-hos@ajums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Vice President of Research and Technology - Dr. Mehrnoosh Zakirkish
Full name of responsible person - Persian: معاونت تحقیقات و فناوری- خانم دکتر مهرنوش ذاکرکیش
Street address - English: Ahvaz Golestan Boulevard. Esfand St. Jundishapur University of Medical Sciences
Street address - Persian: اهواز. بلوار گلستان. خیابان اسفند. دانشگاه علوم پزشکی جندی شاپور
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3311 2392
Fax:
Email: hakim3448200@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Vice President of Research and Technology - Dr. Mehrnoosh Zakirkish
Full name of responsible person - Persian: معاونت تحقیقات و فناوری- خانم دکتر مهرنوش ذاکرکیش
Street address - English: Jundishapur University of Medical Sciences, Esfand street, Golestan boulevard ,Ahvaz
Street address - Persian: اهواز, بلوار گلستان، خیابان اسفند، دانشگاه علوم پزشکی جندی شاپور
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3311 2392
Fax:
Email: hakim3448200@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Vice President of Research and Technology - Dr. Mehrnoosh Zakirkish Full name of responsible person - Persian: معاونت تحقیقات و فناوری- خانم دکتر مهرنوش ذاکرکیش Street address - English: Ahvaz Golestan Boulevard. Esfand St. Jundishapur University of Medical Sciences, Esfand street, Golestan boulevard ,Ahvaz Street address - Persian: اهواز., بلوار گلستان.، خیابان اسفند.، دانشگاه علوم پزشکی جندی شاپور City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6135715794 Phone: +98 61 3311 2392 Fax: Email: hakim3448200@yahoo.com Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ashraf al-Sadat Hakim
Full name of responsible person - Persian: اشرف السادات حکیم
Position - English: Assistant professor, faculty member
Position - Persian: استادیار، عضو هیات علمی
Latest degree: master
Area of specialty/work: 74
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Jundishapur University of Medical Sciences, Esfand street, Golestan boulevard ,Ahvaz
Street address - Persian: اهواز, بلوار گلستان,خیابان اسفند,دانشگاه علوم پزشکی جندی شاپور
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6173333183
Phone: +98 61 3311 2392
Mobile: +98 916 344 8200
Fax:
Email: hakim3448200@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ashrafalsadat Hakim
Full name of responsible person - Persian: اشرف السادات حکیم
Position - English: Assistant professor, faculty member
Position - Persian: استادیار، عضو هیات علمی
Latest degree: master
Area of specialty/work: 74
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Jundishapur University of Medical Sciences, Esfand street, Golestan boulevard ,Ahvaz
Street address - Persian: اهواز, بلوار گلستان,خیابان اسفند,دانشگاه علوم پزشکی جندی شاپور
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6173333183
Phone: +98 61 3311 2392
Mobile: +98 916 344 8200
Fax:
Email: hakim3448200@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ashraf al-SadatAshrafalsadat Hakim Full name of responsible person - Persian: اشرف السادات حکیم Position - English: Assistant professor, faculty member Position - Persian: استادیار، عضو هیات علمی Latest degree: master Area of specialty/work: 74 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Jundishapur University of Medical Sciences, Esfand street, Golestan boulevard ,Ahvaz Street address - Persian: اهواز, بلوار گلستان,خیابان اسفند,دانشگاه علوم پزشکی جندی شاپور City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6173333183 Phone: +98 61 3311 2392 Mobile: +98 916 344 8200 Fax: Email: hakim3448200@yahoo.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ashraf al-Sadat Hakim
Full name of responsible person - Persian: اشرف السادات حکیم
Position - English: Assistant professor, faculty member
Position - Persian: استادیار، عضو هیئت علمی
Latest degree: master
Area of specialty/work: 74
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Jundishapur University of Medical Sciences, Esfand street, Golestan boulevard ,Ahvaz
Street address - Persian: اهواز. بلوار گلستان، خیابان اسفند، دانشگاه علوم پزشکی اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6173333183
Phone: +98 61 3311 2392
Mobile: +98 916 344 8200
Fax:
Email: hakim3448200@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ashrafalsadat Hakim
Full name of responsible person - Persian: اشرف السادات حکیم
Position - English: Assistant professor, faculty member
Position - Persian: استادیار، عضو هیئت علمی
Latest degree: master
Area of specialty/work: 74
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Jundishapur University of Medical Sciences, Esfand street, Golestan boulevard ,Ahvaz
Street address - Persian: اهواز. بلوار گلستان، خیابان اسفند، دانشگاه علوم پزشکی اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6173333183
Phone: +98 61 3311 2392
Mobile: +98 916 344 8200
Fax:
Email: hakim3448200@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ashraf al-SadatAshrafalsadat Hakim Full name of responsible person - Persian: اشرف السادات حکیم Position - English: Assistant professor, faculty member Position - Persian: استادیار، عضو هیئت علمی Latest degree: master Area of specialty/work: 74 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Jundishapur University of Medical Sciences, Esfand street, Golestan boulevard ,Ahvaz Street address - Persian: اهواز. بلوار گلستان، خیابان اسفند، دانشگاه علوم پزشکی اهواز City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6173333183 Phone: +98 61 3311 2392 Mobile: +98 916 344 8200 Fax: Email: hakim3448200@yahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ashraf al-Sadat Hakim
Full name of responsible person - Persian: اشرف السادات حکیم
Position - English: Assistant professor, faculty member
Position - Persian: استادیار، عضو هیئت علمی
Latest degree: master
Area of specialty/work: 74
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Jundishapur University of Medical Sciences, Esfand street, Golestan boulevard ,Ahvaz
Street address - Persian: اهواز، بلوار گلستان، خیابان اسفند، دانشگاه علوم پزشکی اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6173333183
Phone: +98 61 3311 2392
Mobile: +98 916 344 8200
Fax:
Email: hakim344200@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ashrafalsadat Hakim
Full name of responsible person - Persian: اشرف السادات حکیم
Position - English: Assistant professor, faculty member
Position - Persian: استادیار، عضو هیئت علمی
Latest degree: master
Area of specialty/work: 74
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Jundishapur University of Medical Sciences, Esfand street, Golestan boulevard ,Ahvaz
Street address - Persian: اهواز، بلوار گلستان، خیابان اسفند، دانشگاه علوم پزشکی اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6173333183
Phone: +98 61 3311 2392
Mobile: +98 916 344 8200
Fax:
Email: hakim344200@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ashraf al-SadatAshrafalsadat Hakim Full name of responsible person - Persian: اشرف السادات حکیم Position - English: Assistant professor, faculty member Position - Persian: استادیار، عضو هیئت علمی Latest degree: master Area of specialty/work: 74 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Jundishapur University of Medical Sciences, Esfand street, Golestan boulevard ,Ahvaz Street address - Persian: اهواز، بلوار گلستان، خیابان اسفند، دانشگاه علوم پزشکی اهواز City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6173333183 Phone: +98 61 3311 2392 Mobile: +98 916 344 8200 Fax: Email: hakim344200@yahoo.com Web page address:
Protocol summary
Study aim
Determining the effectiveness of clinical guidelines on the care performance of mothers with children with cystic fibrosis
Design
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.
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Caring function of Cystic fibrosis
General information
Reason for update
Acronym
IRCT registration information
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
Registration date
2024-06-02, 1403/03/13
Registrant information
Name
Sara Karimpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 2392
Email address
karimpoor.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-09, 1403/03/20
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of implementing clinical practice guideline on the care performance of mothers with children with cystic fibrosis
Public title
The effect of clinical guidelines on the care performance of mothers with children with cystic fibrosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
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
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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
Ethics Committee of Ahvaz Jundi Shapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Esfand street, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2024-04-29, 1403/02/10
Ethics committee reference number
IR.AJUMS.REC.1403.031
Health conditions studied
1
Description of health condition studied
cystic fibrosis
ICD-10 code
E84.9
ICD-10 code description
Cystic fibrosis, unspecified
Primary outcomes
1
Description
Caring function of cystic fibrosis
Timepoint
Before the start of the intervention and two months after the intervention
Method of measurement
Researcher-made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Behavior
2
Description
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.