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Effectiveness of respiratory care training on sleep quality of children with neuromuscular disease (NMD) and the stress of their parents

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History
# Registration date Revision Id
2 2025-10-28, 1404/08/06 361720
1 2023-04-25, 1402/02/05 262649
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  • Protocol summary

    Determining the effectiveness of the educational-respiratory care program on the sleep quality of children suffering from neuromuscular diseases referred to armed forces hospitals and the stress of their parents in 1401
    Determining the effectiveness of the educational-respiratory care program on the sleep quality of children suffering from neuromuscular diseases and the stress of their parents
    تعیین بررسی اثربخشی برنامه آموزشی - مراقبتی تنفسی بر کیفیت خواب کودکان مبتلا به بیماری‌های عصبی عضلانی مراجعه‌کننده به بیمارستان‌های نیروهای مسلح و استرس والدین آنها در سال 1401
    تعیین اثربخشی برنامه آموزشی - مراقبتی تنفسی بر کیفیت خواب کودکان مبتلا به بیماری‌های عصبی عضلانی و استرس والدین آنها
    Clinical trial with control group, with parallel groups, single-blind, randomized, on 44 patients. RAS software will be used for randomization.
    Clinical trial with control group, with parallel groups, single-blind, randomized, on 50 patients and their parents. RAS software will be used for randomization.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، تصادفی شده، بر روی 44 بیمار. برای تصادفی سازی از نرم افزار RAS استفاده خواهد شد.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، تصادفی شده، بر روی 50 بیمار و والدین آنها برای تصادفی سازی از نرم افزار RAS استفاده خواهد شد.
    The present descriptive-clinical trial research will be conducted in armed forces hospitals. After collecting the information with the questionnaire, the eligible samples will be assigned to the control or intervention group to implement the intervention. The intervention group will receive a care training program to improve the respiratory condition of their children. The data analyst will be blinded.
    The present clinical trial research will be conducted in armed forces hospitals. After collecting the information with the questionnaire, the eligible samples will be assigned to the control or intervention group to implement the intervention. The intervention group will receive a care training program to improve the respiratory condition of their children. The data analyst will be blinded.
    پژوهش توصیفی-کارآزمایی بالینی حاضر در بیمارستان‌های نیروهای مسلح انجام خواهد شد. پس از جمع‌آوری اطلاعات با پرسش‌نامه‌، نمونه‌های دارای واجد شرایط به گروه کنترل یا مداخله جهت اجرای مداخله اختصاص داده خواهند شد. گروه مداخله یک برنامه آموزشی مراقبتی در جهت بهبود وضعیت تنفسی کودکان خود دریافت خواهند کرد. آنالیز کننده داده ها کور خواهد بود.
    پژوهش-کارآزمایی بالینی حاضر در بیمارستان‌های نیروهای مسلح انجام خواهد شد. پس از جمع‌آوری اطلاعات با پرسش‌نامه‌، نمونه‌های دارای واجد شرایط به گروه کنترل یا مداخله جهت اجرای مداخله اختصاص داده خواهند شد. گروه مداخله یک برنامه آموزشی مراقبتی در جهت بهبود وضعیت تنفسی کودکان خود دریافت خواهند کرد. آنالیز کننده داده ها کور خواهد بود.

  • General information

    44
    50
    2023-04-02, 1402/01/13
    2023-12-02, 1402/09/11
    2023-06-03, 1402/03/13
    2024-06-02, 1403/03/13
    empty
    The study's sample size has been corrected.
    empty
    جهت اصلاح تعداد نمونه های وارد شده به مطالعه بروز رسانی انجام شد.
    کودکان به روش نمونه‌گیری در دسترس انتخاب شده و در نهایت هرکدام از نمونه‌های انتخاب شده با نرم افزار Random allocation software(RAS) به گروه کنترل یا مداخله اختصاص داده خواهند شد. به این صورت که در پنجره اصلی برنامه تعداد گروه ها(2 گروه)، اندازه نمونه(44) و نام هر گروه( گروه مداخله و گروه کنترل) مشخص خواهد شد. سپس در قسمت تنظیمات، گزینه تصادفی سازی با بلوک های یکسان تنظیم خواهدشد و با زدن گزینه ایجاد(generate) توالی در قالب چندین ستون ظاهر می شود که مشخص شده است که هر نمونه باید به کدام گروه اختصاص یابد.
    کودکان به روش نمونه‌گیری در دسترس انتخاب شده و در نهایت هرکدام از نمونه‌های انتخاب شده با نرم افزار Random allocation software(RAS) به گروه کنترل یا مداخله اختصاص داده خواهند شد. به این صورت که در پنجره اصلی برنامه تعداد گروه ها(2 گروه)، اندازه نمونه(50) و نام هر گروه( گروه مداخله و گروه کنترل) مشخص خواهد شد. سپس در قسمت تنظیمات، گزینه تصادفی سازی با بلوک های یکسان تنظیم خواهدشد و با زدن گزینه ایجاد(generate) توالی در قالب چندین ستون ظاهر می شود که مشخص شده است که هر نمونه باید به کدام گروه اختصاص یابد.
    انالیز را با کد گزاری دادها و بی نام کردن پرسشنامه انجام خواهم داد
    انالیز را با کد گزاری دادها و بی نام کردن پرسشنامه انجام خواهیم داد

  • Recruitment centers

    #1
    Name of recruitment center - English: Baqiyatullah Hospital
    Name of recruitment center - Persian: بیمارستان بقیه الله
    Full name of responsible person - English: ملیحه سادات موید
    Full name of responsible person - Persian: Malihe sadat moayed
    Street address - English: Baqiyatullah Al-Azam Hospital, after Sheikh Bahai,Mulla Sadra Street, Vanak Square, Tehran
    Street address - Persian: تهران، میدان ونک خیابان ملاصدرا بعد از شیخ بهایی بیمارستان بقیه الله الاعظم (عج)
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1435915371
    Phone: +98 21 8805 0436
    Fax:
    Email: pr@bmsu.ac.ir
    Web page address:
    Name of recruitment center - English: Baqiyatallah Hospital
    Name of recruitment center - Persian: بیمارستان بقیه الله
    Full name of responsible person - English: Malihe sadat moayed
    Full name of responsible person - Persian: ملیحه آلسادات مؤید
    Street address - English: Baqiyatullah Al-Azam Hospital, after Sheikh Bahai,Mulla Sadra Street, Vanak Square, Tehran
    Street address - Persian: تهران، میدان ونک خیابان ملاصدرا بعد از شیخ بهایی بیمارستان بقیه الله الاعظم (عج)
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1435915371
    Phone: +98 21 8805 0436
    Fax:
    Email: msmoayed@bmsu.ac.ir
    Web page address:

Protocol summary

Study aim
Determining the effectiveness of the educational-respiratory care program on the sleep quality of children suffering from neuromuscular diseases and the stress of their parents
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, on 50 patients and their parents. RAS software will be used for randomization.
Settings and conduct
The present clinical trial research will be conducted in armed forces hospitals. After collecting the information with the questionnaire, the eligible samples will be assigned to the control or intervention group to implement the intervention. The intervention group will receive a care training program to improve the respiratory condition of their children. The data analyst will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All children who do not have good sleep quality based on the score obtained in the questionnaire.Do not take specific medicine for insomnia. Parents do not have a mood disorder. Exclusion criteria: Incomplete participation of parents in filling out questionnaires or attending meetings. Dissatisfaction and unwillingness of the child's family to continue working with the researcher
Intervention groups
For the parents and children of the intervention group, in 4 sessions of 75 minutes, a care training program including effective breathing methods, exercises to increase the strength of the respiratory muscles, specialized care in removing airway secretions, effective cough, postural drainage and suction of secretions, oxygen therapy and cardiac resuscitation. Pulmonary will be done.The control group will receive the usual parental care related to respiratory care of their previously trained children.
Main outcome variables
Improving the sleep status of NMD children, reducing the stress of parents with NMD children

General information

Reason for update
The study's sample size has been corrected.
Acronym
IRCT registration information
IRCT registration number: IRCT20221231056998N1
Registration date: 2023-04-25, 1402/02/05
Registration timing: prospective

Last update: 2025-11-05, 1404/08/14
Update count: 1
Registration date
2023-04-25, 1402/02/05
Registrant information
Name
Malihe Sadat Moayed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8755 5503
Email address
msmoayed@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-02, 1402/09/11
Expected recruitment end date
2024-06-02, 1403/03/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of respiratory care training on sleep quality of children with neuromuscular disease (NMD) and the stress of their parents
Public title
"Effectiveness of respiratory care training on sleep quality of children with neuromuscular disease (NMD)"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with neuromuscular diseases who do not have a good quality of sleep based on the score of the questionnaire. Do not take specific medicine for insomnia problems. The ability of parents to participate in webinars The child's family has the desire and consent to participate in the study. The parents do not have a mood disorder (not taking medication and not experiencing other stressful conditions outside of the child's hospitalization during the child's hospitalization)
Exclusion criteria:
Incomplete participation of parents in filling out questionnaires or participating in meetings Dissatisfaction and unwillingness of the child's family to continue working with the researcher Death of a child Having more than one child with NMD disease Having more than one child with NMD disease
Age
To 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Children were selected by available sampling method and finally, each of the selected samples will be assigned to the control or intervention group with Random Allocation Software (RAS). In the main window of the program, the number of groups (2 groups), the sample size (44) and the name of each group (intervention group and control group) will be specified. Then, in the settings section, the randomization option will be set with the same blocks, and by clicking the generate option, the sequence will appear in the form of several columns, which indicate which group each sample should be assigned to.
Blinding (investigator's opinion)
Single blinded
Blinding description
I will do the analysis by coding the data and anonymizing the questionnaire
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in biomedical research
Street address
Research Management,Ground Floor, Research Institute of Baqiyatullah University of Medical Sciences,
City
tehran
Province
Tehran
Postal code
8344117875
Approval date
2023-03-01, 1401/12/10
Ethics committee reference number
IR.BMSU.BAQ.REC.1401.129

Health conditions studied

1

Description of health condition studied
Neuromuscular diseases
ICD-10 code
G71.0
ICD-10 code description
Muscular dystrophy

Primary outcomes

1

Description
Children's sleep quality in Owens et al.'s questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and 14 days after the start of the intervention
Method of measurement
Owens et al.'s Children's Sleep Habits Questionnaire

2

Description
Parental stress
Timepoint
At the beginning of the study (before the start of the intervention) and 14 days after the start of the intervention
Method of measurement
stress response inventory scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the parents and children of the intervention group, airway clearing training and breathing exercises will be carried out in the form of a care training program that includes effective breathing methods, exercises to increase the strength of the respiratory muscles, abdominal breathing training, specialized care in removing airway secretions, Effective cough, postural drainage and suction of secretions, proper position and ways of oxygen therapy, mouthwash and cardiopulmonary resuscitation will be effective. This training course will include 4 sessions of 75 minutes during a period of two weeks (two training sessions per week) of webinar training with the participation of parents on social networks.Also, educational content prepared for parents in the form of audio recording, as well as webinar video and pdf file will be shared on social networks for parents.
Category
Prevention

2

Description
Control group: The control group will receive the usual parental care that the parents have already been trained to take care of their children's breathing, and the questionnaires will be completed at the beginning and two weeks after the end of the intervention. The educational content will be provided to the control group after the completion of the research.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Malihe sadat moayed
Street address
Baqiyatullah Al-Azam Hospital, after Sheikh Bahai,Mulla Sadra Street, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
msmoayed@bmsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Malihe sadat moayed
Street address
Research and Technology Vice-Chancellor, 3rd Floor, , after Sheikh Bahai,Mulla Sadra Street, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
pr@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Malihe Sadat Moayed
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sheikh bahaee
City
Tehran
Province
Tehran
Postal code
8344117875
Phone
+98 21 8755 5503
Fax
Email
msmoayed@bmsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Malihe Sadat Moayed
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sheikh bahaee
City
Tehran
Province
Tehran
Postal code
8344117875
Phone
+98 21 8755 5503
Fax
Email
msmoayed@bmsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Malihe Sadat Moayed
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sheikh bahaee
City
Tehran
Province
Tehran
Postal code
8344117875
Phone
+98 21 8755 5503
Fax
Email
msmoayed@bmsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of the data of military families, it is not possible to publish it
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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