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The effect of scheduled exercises on sleep habits of children with asthma

Protocol summary

Study aim
Determining the effect of scheduled exercises on sleep habits of children with asthma
Design
Clinical trial with control group, with 2 parallel groups, without blinding, randomized, with 60 patients.
Settings and conduct
In the intervention group, the scheduled exercises in the physiotherapy ward of Akbar Children's Hospital will be taught to the children by the researcher. Then they will do exercises at home for eight weeks and 6 sessions per week (3 sessions of breathing exercises and 3 sessions of physical exercises periodically).
Participants/Inclusion and exclusion criteria
The desire of the child and her/his parents to participate in the research The age of the child is from 6 years to 15 years Registration of mild to moderate persistent asthma according to the doctor (at least 3 months ago) the child's asthma is well controlled Permission from the treating physician to participate in the research Attendance of the child in physiotherapy, occupational therapy and rehabilitation programs Have a history of regular exercise in the last 6 months Having a specific mental illness Having epilepsy Have a history of heart and thyroid disease Existence of movement problems or joint disorders Use of sleeping pills and tobacco Having known congenital disorders
Intervention groups
For the intervention group, the scheduled exercises will be performed for eight weeks and six sessions per week (3 sessions of breathing exercises and 3 sessions of physical exercises) in a safe space at home. During this period, the control group, while receiving the routine process, will continue their normal daily activities and will receive an educational pamphlet on routine care of a child with asthma.
Main outcome variables
improved Resistance to going to bed, Delayed sleep onset time, Duration of sleep, Sleep anxiety, Night awakenings, Parasomnia, Respiratory problems in sleep, Daily drowsiness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210830052343N1
Registration date: 2021-10-10, 1400/07/18
Registration timing: registered_while_recruiting

Last update: 2021-10-10, 1400/07/18
Update count: 0
Registration date
2021-10-10, 1400/07/18
Registrant information
Name
Saeed Parnian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5345 3019
Email address
parnians992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-09, 1400/07/17
Expected recruitment end date
2021-12-08, 1400/09/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of scheduled exercises on sleep habits of children with asthma
Public title
The effect of exercise on sleep habits of children with asthma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The desire of the child and her/his parents to participate in the research The age of the child is from 6 years to 15 years Registration of mild to moderate persistent asthma according to the doctor (at least 3 months ago) According to the doctor's diagnosis, the child's asthma is well controlled Permission from the treating physician to participate in the research
Exclusion criteria:
Attendance of the child in physiotherapy, occupational therapy and rehabilitation programs Have a history of regular exercise in the last 6 months Having a specific mental illness Having epilepsy Have a history of heart and thyroid disease Existence of movement problems or joint disorders Use of sleeping pills and tobacco Having known congenital disorders
Age
From 6 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
First, based on the inclusion criteria, available sampling will be done and then the list of sample people will be given to SPSS software and using random block sequence generation software, half of the sample will be allocated to the intervention group and the other half to the control group. Concealment of random allocation will be done by the method of opaque sealed envelopes.
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 Mashhad University of Medical Sciences
Street address
the central building of Mashhad University of Medical Sciences, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-09-14, 1400/06/23
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.053

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
X (J45)
ICD-10 code description
Diseases of the respiratory system (Asthma)

Primary outcomes

1

Description
Sleep Habits Score in Children's Sleep Habits Questionnaire
Timepoint
Sleep habits will be measured in 3 times. 1. Before the intervention 2. During the intervention (4 weeks after the start of the intervention) 3. After the intervention
Method of measurement
Children's Sleep Habits Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, the scheduled exercises will be taught to children and parents by the researcher in the physiotherapy department of Akbar Children's Hospital. After the training session, these children will perform the exercises in three sleeping, sitting and standing positions in a safe space at home for eight weeks and six sessions per week (3 sessions of physical exercises and 3 sessions of breathing exercises- periodically). One physical training session will include 3 parts of warm-up movements (10-15 minutes), selected core exercises (30-35 minutes) and cooling exercises (about 10 minutes). Breathing exercises will include normal breathing, bud lip breathing, and diaphragmatic breathing. Each session will gradually increase the number and timing of physical exercises and breathing exercises.
Category
Lifestyle

2

Description
Control group: Children in the control group will receive routine care during this period and will engage in normal and daily physical activities. They will also receive an educational pamphlet on routine care for a child with asthma.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar Children's Hospital
Full name of responsible person
Dr. Seyyed Ali Jafari
Street address
Akbar Children's Hospital, in front of Shahid Kaveh 24, Shahid Kaveh Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Fax
+98 51 3870 9201
Email
ak.pr@mums.ac.ir
Web page address
https://akbar.mums.ac.ir/

2

Recruitment center
Name of recruitment center
Dr. Seyyed Javad Seyyedi's office
Full name of responsible person
Dr. Seyyed Javad Seyyedi
Street address
Haami Doctors Building, No. 162, between Naser Khosrow St. and Abuzar Ghaffari Intersection, Besat Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3841 2550
Fax
+98 51 3841 2550
Email
sayedij@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi Piyade Gheybi
Street address
the central building of Mashhad University of Medical Sciences, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Parnian
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Golestan Dormitory, Dormitory Affairs Office, Mashhad University of Medical Sciences Campus, Shahid Saremi Blvd., Piroozi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 71 5345 3019
Fax
Email
Parnians992@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Monir Ramezani Farmad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St., Doctora Crossroads, University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
RamezaniMN@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Parnian
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Golestan Dormitory, Dormitory Affairs Office, Mashhad University of Medical Sciences Campus, Shahid Saremi Blvd., Piroozi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 71 5345 3019
Fax
Email
Parnians992@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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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