The Effect of Sleep hygıene traınıng on Blood Sugar regulatıon
NCT ID: NCT04918004
Last Updated: 2021-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
347 participants
INTERVENTIONAL
2018-01-01
2018-11-30
Brief Summary
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Detailed Description
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In this randomised controlled study, it is aimed to provide evidence for the guidelines on the treatment of diabetes by demonstrating whether the education that includes simple lifestyle changes to increase sleep hygiene will have an effect on blood glucose regulation of Type 2 diabetes patients.
In the power analysis based on the tests to be used, when Type 1 error (α) = 0.05, Type 2 error (1-β) = 0.95, effect size is considered as 0.5; it was calculated that the sample size should be 210 (105 for each group) in total.
Patients with sleep disorders, language or psychiatric problems known to interfere with responding to the questionnaire, and patients whose antidiabetic treatment was changed at the first control examination will be excluded from the study.
In their first visit, the participants will be administered a routine diabetes control including HbA1c measurements, as well as a sociodemographic data collection questionnaire prepared by the researchers, a questionnaire consisting of 20 questions including questions about diabetes and sleep problems, and the Turkish version of the Pittsburgh Sleep Quality Index (PSQI) by face-to-face interview technique.
In addition, each patient included in the case group was given a brochure containing one-on-one sleep hygiene education and 10 lifestyle changes related to sleep hygiene, the content of which was created by the researchers.
Recommendations in the sleep hygiene leaflet :
* Enter the bed when you feel sleepy. If you lie in bed for more than half an hour, get out of bed. When you feel sleepy, go back to bed
* Do not sleep more than 1 hour during the day time.
* Avoid heavy and fatty meals in the evening, do not go to bed very hungry or very satiated. Avoid beverages such as coffee, tea, coke, energy drinks and alcohol.
* Exercise or walk regularly in the evening, but avoid physically strenuous activities 3-4 hours before bedtime
* In order for your body clock to work properly, live regularly. Get out of bed at the same time everyday. Wake up at the time you should wakeup in the morning, even if you went to bed at a different time of the night. Follow this rule, even on the weekend, and make it a habit to always get up at the same time. Sleeping and awakening times are important in maintaining sleep patterns.
* Use the bed for sleep purposes only. Do not do activities such as eating, watching TV, reading a book, or planning the next day in bed.
* Make sure your bedroom is quiet and dark
* Avoid exciting activities such as watching horror movies or reading adventure boks before going to bed
* Try to avoid a stressful life.
* Never take sleeping pills without your doctor's knowledge.
At the next visit of all participants, a second visit PSQI will be administered in addition to HbA1c, and a statement-based "sleep hygiene education compliance questionnaire" will be administered to the case group, questioning whether they have complied with the items in the sleep hygiene education material recommended at the first interview.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Case group
Patients in the case group were given one-to-one sleep hygiene training by researchers and, a brochure containing 10 lifestyle changes related to sleep hygiene as well as they assessed at the first interview and the last interview, received routine health care, and
Sleep Hygiene
1. One-to-one sleep hygiene training, the content of which was created by the researchers,
2. A brochure containing 10 lifestyle changes related to sleep hygiene
Control group
Patients in the control group were assessed at the first interview and the last interview, received routine health care, and no intervention was performed during the research.
No interventions assigned to this group
Interventions
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Sleep Hygiene
1. One-to-one sleep hygiene training, the content of which was created by the researchers,
2. A brochure containing 10 lifestyle changes related to sleep hygiene
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Language or psychiatric problems that prevented responding to the questionnaire
* Patients who underwent changes in their antidiabetic treatment during the first control examination
* Those who did not re-admit to the hospital for routine check-ups within 6 months after the first visit
* Patients who declared not to comply with the recommendations were excluded from the study
ALL
No
Sponsors
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Diskapi Yildirim Beyazit Education and Research Hospital
OTHER_GOV
Responsible Party
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Süleyman Görpelioğlu
Clinical Professor
Principal Investigators
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Süleyman Görpelioğlu, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Academic staff
Locations
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University of Health Sciences Turkey Ankara Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, Altındağ, Turkey (Türkiye)
Countries
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References
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Kachi Y, Nakao M, Takeuchi T, Yano E. Association between insomnia symptoms and hemoglobin A1c level in Japanese men. PLoS One. 2011;6(7):e21420. doi: 10.1371/journal.pone.0021420. Epub 2011 Jul 1.
Tan X, van Egmond L, Chapman CD, Cedernaes J, Benedict C. Aiding sleep in type 2 diabetes: therapeutic considerations. Lancet Diabetes Endocrinol. 2018 Jan;6(1):60-68. doi: 10.1016/S2213-8587(17)30233-4. Epub 2017 Aug 24.
Nedeltcheva AV, Scheer FA. Metabolic effects of sleep disruption, links to obesity and diabetes. Curr Opin Endocrinol Diabetes Obes. 2014 Aug;21(4):293-8. doi: 10.1097/MED.0000000000000082.
Spiegel K, Tasali E, Leproult R, Van Cauter E. Effects of poor and short sleep on glucose metabolism and obesity risk. Nat Rev Endocrinol. 2009 May;5(5):253-61. doi: 10.1038/nrendo.2009.23.
Lee SWH, Ng KY, Chin WK. The impact of sleep amount and sleep quality on glycemic control in type 2 diabetes: A systematic review and meta-analysis. Sleep Med Rev. 2017 Feb;31:91-101. doi: 10.1016/j.smrv.2016.02.001. Epub 2016 Feb 9.
Smyth A, Jenkins M, Dunham M, Kutzer Y, Taheri S, Whitehead L. Systematic review of clinical practice guidelines to identify recommendations for sleep in type 2 diabetes mellitus management. Diabetes Res Clin Pract. 2020 Dec;170:108532. doi: 10.1016/j.diabres.2020.108532. Epub 2020 Nov 4.
Zhu B, Hershberger PE, Kapella MC, Fritschi C. The relationship between sleep disturbance and glycaemic control in adults with type 2 diabetes: An integrative review. J Clin Nurs. 2017 Dec;26(23-24):4053-4064. doi: 10.1111/jocn.13899. Epub 2017 Jul 17.
Chasens ER, Korytkowski M, Sereika SM, Burke LE. Effect of poor sleep quality and excessive daytime sleepiness on factors associated with diabetes self-management. Diabetes Educ. 2013 Jan-Feb;39(1):74-82. doi: 10.1177/0145721712467683. Epub 2012 Nov 27.
Seibert PS, Valerio J, DeHaas C. The concomitant relationship shared by sleep disturbances and type 2 diabetes: developing telemedicine as a viable treatment option. J Diabetes Sci Technol. 2013 Nov 1;7(6):1607-15. doi: 10.1177/193229681300700621.
Larcher S, Benhamou PY, Pepin JL, Borel AL. Sleep habits and diabetes. Diabetes Metab. 2015 Sep;41(4):263-271. doi: 10.1016/j.diabet.2014.12.004. Epub 2015 Jan 23.
Related Links
Access external resources that provide additional context or updates about the study.
TEMD Diabetes Mellitus Çalışma ve Eğitim Grubu, Diagnosis and Monitoring Guide for Diabetes Mellitus and Its Complications 2020 Türkiye Endokrinoloji ve Metabolizma Derneği: 2020. p.40-44
Agargün M Y, Kara H, Anlar O (1996) Validity and Reliability of Pittsburgh Sleep Quality. Türk Psikiyatri Dergisi, 7: 107-115.
TurcosaAnalytics (2021). TURCOSA \[Cloud-based statistical software\].
Other Identifiers
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27.11.2017 - 43/06
Identifier Type: -
Identifier Source: org_study_id
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