Protocol summary
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Study aim
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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
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Design
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Clinical trial with control group, with parallel groups, single-blind, randomized, on 50 patients and their parents. RAS software will be used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Improving the sleep status of NMD children, reducing the stress of parents with NMD children
General information
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Reason for update
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The study's sample size has been corrected.
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Acronym
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IRCT registration information
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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
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Registration date
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2023-04-25, 1402/02/05
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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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2023-12-02, 1402/09/11
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Expected recruitment end date
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2024-06-02, 1403/03/13
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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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Effectiveness of respiratory care training on sleep quality of children with neuromuscular disease (NMD) and the stress of their parents
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Public title
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"Effectiveness of respiratory care training on sleep quality of children with neuromuscular disease (NMD)"
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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To 18 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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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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I will do the analysis by coding the data and anonymizing the questionnaire
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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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2023-03-01, 1401/12/10
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Ethics committee reference number
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IR.BMSU.BAQ.REC.1401.129
Health conditions studied
1
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Description of health condition studied
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Neuromuscular diseases
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ICD-10 code
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G71.0
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ICD-10 code description
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Muscular dystrophy
Primary outcomes
1
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Description
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Children's sleep quality in Owens et al.'s questionnaire
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Timepoint
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At the beginning of the study (before the start of the intervention) and 14 days after the start of the intervention
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Method of measurement
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Owens et al.'s Children's Sleep Habits Questionnaire
2
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Description
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Parental stress
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Timepoint
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At the beginning of the study (before the start of the intervention) and 14 days after the start of the intervention
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Method of measurement
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stress response inventory scale
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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Category
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Other
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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Bagheiat-allah 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Due to the confidentiality of the data of military families, it is not possible to publish it
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be 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