Determining The effect of Core Stability Exercises on sleep habits and quality of life in children with nocturnal enuresis
Design
Clinical trial with control group, with single, randomized groups, 70 patients
Settings and conduct
Approval of the research plan in the university ethics committee. At the beginning of the study, complete the demographic characteristics checklist, Children's Sleep Habits Questionnaire and The Pediatric Quality of Life Inventory. In the intervention group, In eight weeks, the exercises will be done three sessions a week (the interval between the training sessions is one day) and each session will be 45 minutes as a group. 48 hours after completing the interventions, complete the Children's Sleep Habits Questionnaire and The Pediatric Quality of Life Inventory. The place of interventions is in one of the suitable sports halls in Yasuj city.
Participants/Inclusion and exclusion criteria
Admission requirements: Age range from 6 to 12 years. Conditions of non-entry: Previous patient participation in studies similar to the current study
Intervention groups
Intervention group by core stability method: In eight weeks, the exercises will be done three sessions a week (the interval between the training sessions is one day) and each session will be 45 minutes as a group. Control group: non-intervention: this training group will not be given.
Main outcome variables
Sleep habits and Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220803055611N1
Registration date:2022-08-16, 1401/05/25
Registration timing:prospective
Last update:2022-08-16, 1401/05/25
Update count:0
Registration date
2022-08-16, 1401/05/25
Registrant information
Name
Nastaran Kheirandish
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5138
Email address
nastaran.kherandish@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Core Stability Exercises on sleep habits and quality of life in children with nocturnal enuresis
Public title
The effect of Core Stability Exercises on sleep habits and quality of life in children with nocturnal enuresis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 6 to 12 years
Diagnosis of primary and secondary nocturnal enuresis by a specialist in children's kidney diseases
Not doing sports professionally
The quality of life of children with a cut-off point of less than 25 (low quality of life) based on the questionnaire of the quality of life of children
Having the physical ability to participate in sports exercises according to the doctor's opinion
Not suffering from concomitant diseases (cardiac, pulmonary and diabetes)
Consent to participate in the study and sign the informed consent form by the parents and the child
Exclusion criteria:
Previous patient participation in studies similar to the current study
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Block random allocation in such a way that first by multiplying the number of studied groups (two groups) by 2, the number of samples in each block is equal to 4, through factorial calculation, the number of samples in each block (24=1×2×3×4= 4), the number of blocks resulting from all modes of arrangement of people will be calculated as 24 blocks. Then, since the number of people in each block will be 4 people and the estimated sample size is 60 people, therefore, by matching 20 random numbers generated by the Sample Randomizer software with the numbers of the aforementioned states, how to arrange 60 people in the research sample and assign each number from 1 Up to 60 will be assigned to one of the specified intervention and control groups and a block random allocation list will be compiled. After fully explaining and explaining the objectives of the study, eligible research samples will be selected and based on the time priority of referrals, a code will be assigned to each of them, and by matching that number with the random block allocation list, the patients participating in the research will be assigned to one of the intervention and control groups. This process will continue until the estimated sample size is completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2022-06-14, 1401/03/24
Ethics committee reference number
IR.YUMS.REC.1401.031
Health conditions studied
1
Description of health condition studied
Children with nocturnal enuresis
ICD-10 code
F98.0
ICD-10 code description
Nonorganic enuresis
Primary outcomes
1
Description
Outcome number 1: Sleep habits: Sleep habits means the score that a person gets from answering the questions of the children's sleep habits questionnaire.
Timepoint
The amount of sleeping habits of the patients at the beginning of the study (before the start of the intervention) and 48 hours after the completion of the interventions
Method of measurement
Children's Sleep Habits Questionnaire
2
Description
Outcome number 2: Quality of life: Quality of life means the score that a person answers to the questions of the Pediatric Quality of Life Inventory.
Timepoint
The level of quality of life of patients at the beginning of the study (before the start of the intervention) and 48 hours after the completion of the interventions
Method of measurement
The Pediatric Quality of Life Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In eight weeks, the exercises will be done three sessions a week (the interval between the training sessions is one day) and each session will be 45 minutes as a group. The exercises will be as follows: The first session: 1- Raising the arms and legs in a round position 2- Bridging in such a way that the hips and waist rise from the ground. The number of performances of each two hands is 10. The second session: 1- Raising the arms and legs in a distant position 2- Bridging so that the hips and waist rise from the ground. The number of performances of each two hands is 15. The third session: - Raising the arms and legs in a round position 2- Bridging in such a way that the hips and waist rise from the ground. The number of performances of each two hands is 20. The fourth session: - Raising the arms and legs in a round position 2- Bridging in such a way that the hips and waist rise from the ground. The number of performances of each two hands is 25. Fifth session: 1- Lying down with rotation 2- Half lying down. The number of performances of each two hands is 10. Sixth session: 1- Lying down with rotation 2- Half lying down. The number of performances of each two hands is 15. Seventh session: 1- Semi-recumbent sitting 2- Recumbent sitting with rotation. The number of performances of each two hands is 20. Eighth session: 1- Semi-recumbent sitting 2- Recumbent sitting with rotation. The number of performances of each two hands is 25.
Category
Lifestyle
2
Description
Control group: non-intervention: this training group will not be given.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Nastaran Kheirandish
Street address
Shahid Beheshti Hospital, Shahid Montazeri Ave., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7186897477
Phone
+98 74 3322 1813
Fax
+98 74 3322 1811
Email
beheshtihospital@yasooj.ir
2
Recruitment center
Name of recruitment center
Martyr Dr. Jalil Hospital
Full name of responsible person
Nastaran Kheirandish
Street address
Martyr Dr. Jalil Hospital, Qarani Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7001
Email
nkheyrandish1373@gmail.com
3
Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
Nastaran Kheirandish
Street address
Imam Sajjad Hospital, Next to Hotel Azadi, Yasuj, Kohgiloyeh and Boyerahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 0166
Email
nkheyrandish1373@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossaini Motlagh
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
nursing@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Nastaran Kheirandish
Position
Msc student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 1, Aria Building, 49 North Motahari Alley, Shiraz, Fars, Islamic Republic of Iran
City
Shiraz
Province
Fars
Postal code
7186897477
Phone
+98 74 3323 5138
Email
nkheyrandish1373@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Nastaran Kheirandish
Position
Msc student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 1, Aria Building, 49 North Motahari Alley, Shiraz, Fars, Islamic Republic of Iran
City
Shiraz
Province
Fars
Postal code
7186897477
Phone
+98 74 3323 5138
Email
nkheyrandish1373@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Nastaran Kheirandish
Position
Msc student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 1, Aria Building, 49 North Motahari Alley, Shiraz, Fars, Islamic Republic of Iran
City
Shiraz
Province
Fars
Postal code
7186897477
Phone
+98 74 3323 5138
Email
nkheyrandish1373@gmail.com
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