NCT05957874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 9, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

July 9, 2023

Last Update Submit

March 3, 2024

Conditions

Keywords

Sleepsleep deprivationsleep habitnurseschool-age children

Outcome Measures

Primary Outcomes (1)

  • 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

    1st week (pretest)

Secondary Outcomes (1)

  • Sleep Deprivation Scale for Children and Adolescents

    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 Outcomes (1)

  • Child Sleep Habits Questionnaire

    After the pretest in the 1st week, the posttest in the 4th week and the control measurement in the 6th week will be done.

Study Arms (2)

Experiment

EXPERIMENTAL

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.

Other: Combined package program

Control

NO INTERVENTION

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.

Interventions

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.

Experiment

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan Üniversitesi Hemşirelik Fakültesi

Konya, 42250, Turkey (Türkiye)

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

Sleep HygieneSleep Deprivation

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is an experimental study with pretest and posttest control measurement and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Proffessor

Study Record Dates

First Submitted

July 9, 2023

First Posted

July 24, 2023

Study Start

July 9, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

The decision to share the study results will be made during the study period or when it is concluded.

Locations