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The Effect of Sleep Hygiene Training Implemented

Primary Purpose

Sleep Hygiene

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Combined package program
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Hygiene focused on measuring Sleep, sleep deprivation, sleep habit, nurse, school-age children

Eligibility Criteria

9 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The child is studying in the 4th grade (9-11 years old) Ability to read, write and speak Turkish The willingness of the family and the child to participate in the research Having internet access Exclusion Criteria: Using any sleeping pills Presence of a concomitant chronic disease Having received any training on sleep Existence of a situation that will prevent the understanding of the given education

Sites / Locations

  • Necmettin Erbakan Üniversitesi Hemşirelik FakültesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experiment

Control

Arm Description

Questionnaires will be applied to the children and their families who agree to participate. A one-week sleep hygiene training will be given for three consecutive days. On the first day of education, children will be given a checklist and tasks that will facilitate the transition to weekly sleep. In addition, within the scope of using technology positively, reminders including sleep hygiene principles will be sent to families every day for four weeks via a social media tool. Total intervention time is planned as 4 weeks. The researchers planned to start the trainings on Monday. At the beginning of each week, face-to-face interviews will be held with the students in the experimental group and it will be evaluated whether the tasks have been fulfilled. At the end of 4 weeks, the final test application of the experimental group will be made. Then, the questionnaires will be applied again after 2 weeks for control measurement.

The children who agreed to participate in the class determined as the control group as a result of drawing lots and the children and their families who agreed to participate will fill in the "Sociodemographic Characteristics and Introductory Information Form", the "Sleep Deprivation Scale for Children and Adolescents" and the mothers will fill in the "Child Sleep Habits Questionnaire". At the end of 4 weeks, the post-test application of the control group will be made. After the tests are applied, training will be given to the control group on a suitable day for the class and the training booklet will be distributed.

Outcomes

Primary Outcome Measures

Sociodemographic Characteristics and Introductory Information Form
This form, which was created by the researchers by scanning the literature, also includes age, gender, educational status of parents, sleeping and waking hours, etc. There are 17 questions

Secondary Outcome Measures

Sleep Deprivation Scale for Children and Adolescents
In the context of the validity and reliability study of the Child and Adolescent Sleep Deprivation Scale developed by Kandemir et al., this form was created regarding the sleep needs of children and adolescents attending school. The scale can be applied to children and adolescents between the ages of 8-17. The scale, which emerged as a one-dimensional structure, consists of 15 items and a 4-point Likert type prepared as "strongly disagree", "disagree", "agree" and "strongly agree". The Cronbach Alpha value of the scale is 0.94. The lowest score that can be obtained from the scale is 15 and the highest score is 60. As the score from the scale increases, sleep deprivation increases, and as it decreases, sleep deprivation decreases.

Full Information

First Posted
July 9, 2023
Last Updated
July 16, 2023
Sponsor
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT05957874
Brief Title
The Effect of Sleep Hygiene Training Implemented
Official Title
The Effect of Sleep Hygiene Training Implemented With the Combined Package Program on Sleep Deprivation and Sleep Habits in Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Good and quality sleep, which has an important place in the lives of all living things; important for the health and well-being of children. Proper sleep habits are needed for quality and adequate sleep. According to the National Sleep Foundation, these habits include practices such as regular bedtimes, sleep routines, screen restrictions before bed. With the age of starting school in children; Due to the roles brought by school, lessons and social obligations, problems such as delay in bedtime and shorter sleep time are seen. Shortening of sleep time causes sleep deprivation. sleep deprivation; It is defined as a delay in bedtime and a shorter sleep time than would normally be due to intentional or daily activities. The use of sleep hygiene interventions to address sleep deprivation in children is highly effective. Sleep hygiene is a cost-effective method that is performed without the need for any additional material, consisting of both environmental and behavioral habits. In our study, a quasi-experimental pretest-posttest-control study design with a control group will be used to determine the effect of sleep hygiene education applied with the combined package program on sleep deprivation and sleep habits in children. After the necessary permissions are obtained, the classes will be divided into experiments and controls by drawing lots. To the experimental group; After the pre-test is applied, training and tasks will be given. In addition, a sleep hygiene policy will be sent to the families by phone every day. The total intervention will last four weeks, at the end of which a post-test will be administered. Two weeks will be waited without intervention, two weeks later the control measurement will be made. To the control group; Pre-test and post-test will be applied at the same time with the experimental group and training will be given after the post-test. The research data will be evaluated with the Statistical Package for the Social Sciences (SPSS) statistical program on the computer and in the form of numbers, percentages, averages and standard deviations for descriptive statistics in the computer environment and with necessary statistical analyzes. Significance will be accepted as p<0.05 at α=95% confidence interval.
Detailed Description
Sleep; It is a physiological need that has a very strong effect on increasing the quality of life of individuals. Good and quality sleep for children, which has an important place in the lives of all living things; important for their health and well-being. in children; ensuring healthy growth and development, establishment of homeostatic balance mechanism, sensory and hormonal development, improvement of metabolism and immune system, cognitive development, memory, academic performance, cardiovascular risk, obesity; Psychological conditions such as depression, suicidality, paranoia, and hallucinations have been associated with sleep quality and adequacy. Proper sleep habits are needed for quality and adequate sleep. According to the National Sleep Foundation, these habits include practices such as regular bedtimes, sleep routines, screen restrictions before bedtime. A circadian rhythm develops until the age of 6, and after the age of 6, the habit of being a night owl or getting up early is observed. In addition, with the school starting age (after the age of 6), children enter into a busy schedule and their sleeping habits may change. Adequate sleep time for school-age children is 9-11 hours. With the age of starting school in children; Due to the roles brought by school, lessons and social obligations, problems such as delay in bedtime and shorter sleep time are observed. Shortening of sleep time causes sleep deprivation. sleep deprivation; It is defined as a delay in bedtime and a shorter sleep time than it should be, either intentionally or due to daily actions. sleep deprivation in children; It causes decrease in cognitive performance, poor school performance, weakening of mental abilities, daytime sleepiness, lack of physical activity, obesity and changes in dietary habits (short sleep calorie foods and carbonated drink consumption; adequate sleep fruit and vegetable consumption. For these reasons, it is of great importance to eliminate sleep deprivation in children. The use of sleep hygiene interventions to address sleep deprivation in children is highly effective. Sleep hygiene is a set of behaviors that aim to improve sleep quality by eliminating bad sleep habits. Sleep hygiene is a cost-effective method that is performed without the need for any additional material, consisting of both environmental and behavioral habits. It is known that sleep hygiene interventions, especially performed at school, are very effective and applicable. When the literature is examined, sleep hygiene interventions are generally focused on children with a health problem (hyperactivity, autism, sleep problems, etc. Although the effects of sleep on school performance are known, interventions to improve the sleep quality of healthy school-age children are very few. School is a very effective environment in developing healthy behavior, and the home environment is important for the behavior to continue. For these reasons, in our study, school-age children who do not have any health problems will be handled using both the school environment and the home environment. The research to be carried out is unique from other studies in that it aims to create behavior in children by using the school and home environment together and by attracting the attention of the materials used by the children. As a result of the examinations (yök thesis, google academic Turkish, etc.), our research is the first in Turkey in terms of being aimed at healthy children, the intervention for both children and families, and a quasi-experimental research design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Hygiene
Keywords
Sleep, sleep deprivation, sleep habit, nurse, school-age children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is an experimental study with pretest and posttest control measurement and control group.
Masking
Participant
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment
Arm Type
Experimental
Arm Description
Questionnaires will be applied to the children and their families who agree to participate. A one-week sleep hygiene training will be given for three consecutive days. On the first day of education, children will be given a checklist and tasks that will facilitate the transition to weekly sleep. In addition, within the scope of using technology positively, reminders including sleep hygiene principles will be sent to families every day for four weeks via a social media tool. Total intervention time is planned as 4 weeks. The researchers planned to start the trainings on Monday. At the beginning of each week, face-to-face interviews will be held with the students in the experimental group and it will be evaluated whether the tasks have been fulfilled. At the end of 4 weeks, the final test application of the experimental group will be made. Then, the questionnaires will be applied again after 2 weeks for control measurement.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The children who agreed to participate in the class determined as the control group as a result of drawing lots and the children and their families who agreed to participate will fill in the "Sociodemographic Characteristics and Introductory Information Form", the "Sleep Deprivation Scale for Children and Adolescents" and the mothers will fill in the "Child Sleep Habits Questionnaire". At the end of 4 weeks, the post-test application of the control group will be made. After the tests are applied, training will be given to the control group on a suitable day for the class and the training booklet will be distributed.
Intervention Type
Other
Intervention Name(s)
Combined package program
Intervention Description
Combined package program content: Training: A one-week sleep hygiene training will be given to the experimental group. The training will take an average of 30 minutes for three consecutive days and a training booklet will be provided. In addition, two posters will be prepared to hang in the classroom. In one of the posters, a sleep hygiene rule will be placed at each hour using the clock order. In the other poster, good and bad sleep habits will be placed in the form of do-do. Task Flower: Tasks that will facilitate the transition to weekly sleep will be given to the children of the experimental group. Tasks are applications to be done within 30-60 minutes before going to bed. After the tasks, the children will perform their daily sleep routine and go to sleep. Notifications: As part of using technology positively, reminders will be sent to families every day for two weeks via a social media tool. These warnings will include sleep hygiene principles.
Primary Outcome Measure Information:
Title
Sociodemographic Characteristics and Introductory Information Form
Description
This form, which was created by the researchers by scanning the literature, also includes age, gender, educational status of parents, sleeping and waking hours, etc. There are 17 questions
Time Frame
1st week (pretest)
Secondary Outcome Measure Information:
Title
Sleep Deprivation Scale for Children and Adolescents
Description
In the context of the validity and reliability study of the Child and Adolescent Sleep Deprivation Scale developed by Kandemir et al., this form was created regarding the sleep needs of children and adolescents attending school. The scale can be applied to children and adolescents between the ages of 8-17. The scale, which emerged as a one-dimensional structure, consists of 15 items and a 4-point Likert type prepared as "strongly disagree", "disagree", "agree" and "strongly agree". The Cronbach Alpha value of the scale is 0.94. The lowest score that can be obtained from the scale is 15 and the highest score is 60. As the score from the scale increases, sleep deprivation increases, and as it decreases, sleep deprivation decreases.
Time Frame
After the pretest in the 1st week, the posttest in the 4th week and the control measurement in the 6th week will be done.
Other Pre-specified Outcome Measures:
Title
Child Sleep Habits Questionnaire
Description
The abbreviated form of the Children's Sleep Habits Questionnaire (CSHQ), developed by Owens et al. in 2000, was adapted to Turkish by Perdahlı Fiş et al. The scale is filled by the mothers and/or fathers of primary school 1st, 2nd, 3rd, 4th grade students. The mother and/or father are asked to evaluate the child's sleep habits considering the past week. The scale consists of 33 items. The scale has eight sub-dimensions, which can be listed as bedtime resistance, delayed falling asleep, sleep duration, sleep anxiety, night awakenings, parasomnias, impaired breathing during sleep, and daytime sleepiness. Cronbach's alpha value was found to be 0.78. 41 points obtained from the scale are accepted as the cut-off point, and values above this are considered clinically significant.
Time Frame
After the pretest in the 1st week, the posttest in the 4th week and the control measurement in the 6th week will be done.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The child is studying in the 4th grade (9-11 years old) Ability to read, write and speak Turkish The willingness of the family and the child to participate in the research Having internet access Exclusion Criteria: Using any sleeping pills Presence of a concomitant chronic disease Having received any training on sleep Existence of a situation that will prevent the understanding of the given education
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Semra KÖSE, PhD, Asisstant Proffessor
Phone
05433682203
Email
semraak_88@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hacer ORUÇOĞLU, Masterstuden
Email
hacergun92@gmail.com
Facility Information:
Facility Name
Necmettin Erbakan Üniversitesi Hemşirelik Fakültesi
City
Konya
ZIP/Postal Code
42250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Necmettin Fakültesi
Phone
05433682203
Email
semraak_88@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The decision to share the study results will be made during the study period or when it is concluded.
Citations:
Citation
Ahmadi, Z., & Omidvar, S. (2022). The quality of sleep and daytime sleepiness and their association with quality of school life and school achievement among students. Journal of Education and Health Promotion, 11(1), 159. https://doi.org/10.4103/JEHP.JEHP_22_22 Åslund, L., Arnberg, F., Kanstrup, M., & Lekander, M. (2018). Cognitive and Behavioral Interventions to Improve Sleep in School-Age Children and Adolescents: A Systematic Review and Meta-Analysis. Journal of Clinical Sleep Medicine: JCSM: Official Publication of the American Academy of Sleep Medicine, 14(11), 1937. https://doi.org/10.5664/JCSM.7498 Bora, I. H. Dr., & Bican, A. Dr. (2007). Sleep Physiology. Journal of Turkish Clinics, 3(23), 1-6. Busch, V., Altenburg, T. M., Harmsen, I. A., & Chinapaw, M. J. (2017). Interventions that stimulate healthy sleep in school-aged children: a systematic literature review. European Journal of Public Health, 27(1), 53-65. https://doi.org/10.1093/EURPUB/CKW140 Córdova, F. V., Barja, S., & Brockmann, P. E. (2018). Consequences of short sleep duration on the dietary intake in children: A systematic review and metanalysis. Sleep Medicine Reviews, 42, 68-84. https://doi.org/10.1016/J.SMRV.2018.05.006 Freeman, D., Sheaves, B., Goodwin, G. M., Yu, L.-M., Nickless, A., Harrison, P. J., Emsley, R., Luik, A. I., Foster, R. G., Wadekar, V., Hinds , C., Gumley, A., Jones, R., Lightman, S., Jones, S., Bentall, R., Kinderman, P., Rowse, G., Brugha, T., … Espie, C. A. (2017 ). Articles The effects of improving sleep on mental health (OASIS): a randomized controlled trial with mediation analysis. The Lancet. Psychiatry, 749. https://doi.org/10.1016/S2215-0366(17)30328-0 Gruber, R., Somerville, G., Bergmame, L., Fontil, L., & Paquin, S. (2016). School-based sleep education program improves sleep and academic performance of school-age children. https://doi.org/10.1016/j.sleep.2016.01.012 Hirshkowitz, M., Whiton, K., Albert, S. M., Alessi, C., Bruni, O., Doncarlos, L., Hazen, N., Herman, J., Katz, E. S., Kheirandish-Gozal, L., Neubauer, D. N., O'donnell, A. E., Ohayon, M., Peever, J., Rawding, R., Sachdeva, R. C., Setters, B., Vitiello, M. V, Catesby Ware, J., & Hillard, P. J. A. (2015). National Sleep Foundation's sleep time duration recommendations: methodology and results summary. Sleep Health, 1, 40-43. https://doi.org/10.1016/j.sleh.2014.12.010 Hiscock, H., Quach, J., Paton, K., Peat, R., Gold, L., Arnup, S., Sia, K. L., Nicolaou, E., & Wake, M. (2018). Impact of a Behavioral Sleep Intervention on New School Entrants' Social Emotional Functioning and Sleep: A Translational Randomized Trial. https://Doi.Org/10.1080/1540202.2018.1469493, 17(6), 698-712. https://doi.org/10.1080/1540202.2018.1469493 İşsever, O., Akçay Didişen, N., & Bal Yilmaz, H. (2021). An Important Topic in Child Care: Safe Sleep and Sleep Education. Journal of Izmir Katip Celebi University Faculty of Health Sciences, 6(2), 157-161. Kandemir, M., Bozdemir, E., Hayran, Y., Tonga, Z., & Kandemir, A. (2021). Sleep Deprivation Scale for Children and Adolescents. Journal of Interdisciplinary Education: Theory and Practice. https://doi.org/10.47157/jietp.875187 Loring, W., & Malow, B. (2022). Sleep Hygiene and Related Interventions: Their Impact on Sleep. Clinical Handbook of Behavioral Sleep Treatment in Children on the Autism Spectrum, 127-136. https://doi.org/10.1007/978-3-030-99134-0_9 Matricciani, L., Paquet, C., Galland, B., Short, M., & Olds, T. (2019). Children's sleep and health: A meta-review. Sleep Medicine Reviews, 46, 136-150. https://doi.org/10.1016/J.SMRV.2019.04.011
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The Effect of Sleep Hygiene Training Implemented

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