An interventional study of sleep hygiene education and Control in Diabetic Polyneuropathy, Sleep Hygiene and Pain, sponsored by Trakya University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Trakya University · Not applicable, Interventional, and Supportive care
This randomized controlled study was designed to the effect of sleep hygiene education on sleep quality and quality of life in patients with painful diabetic polyneuropathy The study was conducted between January 2025 and January 2026 with 24 patients diagnosed with painful diabetic polyneuropathy (12 experimental, 12 control) at the Neurology clinic and outpatient clinic of a university hospital in Edirne. Data were collected using the "Patient Information Form" including sociodemographic and disease related characteristics, the Electrophysiological Severity Classification, Pittsburgh Sleep Quality Index (PSQI), Brief Pain Inventory (BPI), and SF-12 Health Survey.
Background: Sleep disturbances are common in diabetic polyneuropathy (DPN) and adversely affect physical and psychological well-being. This study aimed to evaluate the effects of sleep hygiene education on sleep quality, pain severity, and quality of life in patients with painful DPN.
Methods: This randomized controlled trial was conducted between January 2025 and January 2026 and enrolled 24 patients with electrophysiologically confirmed painful DPN, randomized equally into intervention (n = 12) and control (n = 12) groups. The intervention group received a standardized sleep hygiene education protocol over three months; the control group continued routine care. Participant blinding was not feasible given the nature of the intervention; statistical analyses were conducted with group codes masked. Outcomes were assessed at baseline (T0), month 1 (T1), and month 3 (T2) using the Pittsburgh Sleep Quality Index (PSQI), Brief Pain Inventory (BPI), and SF-12 Health Survey.
Financial Support: The present study was supported by the Research Fund of Trakya University. Project No: 2025/19
538 studies on the registry are indexed under Diabetic Neuropathies; 80 are open to participants now.
This study's enrollment of 24 is below the median of 68 across 448 interventional studies indexed under Diabetic Neuropathies.
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Exclusion Criteria:
In the first interview, participants were informed about the research process. Patient information forms and scales (Pittsburgh Sleep Quality Index (PSQI), Brief Pain Inventory (BPI), and SF-12 Health Survey) that would be used in data collection were explained to the participants. Participants were informed about how often and how these forms and scales would be applied. No intervention was applied to the participants in the control group in the study.
Other: Control
The participants were informed about the research process during the first meeting. Participants were told that, Participants were told that, if they agreed to participate in the study, Over a three-month period at home, the intervention group followed a standardized sleep hygiene education protocol. Participants were provided with an educational booklet, and face-to-face training was conducted by a nurse in a dedicated outpatient clinic room during the initial visit. Weekly reminder messages were sent to encourage participants to keep following the protocol, and adherence was checked at the 1- and 3-month outpatient visits.
Other: sleep hygiene education
Participants were provided with an educational booklet, and face-to-face training was conducted by a nurse in a dedicated outpatient clinic room during the initial visit.
Participants in the control group continued with their routine treatment and care; no additional educational intervention was provided during this period.
Quality of sleep score
Change in the mean scores of the Pittsburgh Sleep Quality Index (PSQI)at the first interview, on the 30th day and on the 90th day
Time frame: tree month
Quality of life score
Change in the mean scores of the SF-12 Health Survey at the first interview, on the 30th day and on the 90th day
Time frame: three month
Pain inventory score
Change in the mean scores of the Brief Pain Inventory (BPI) at the first interview, on the 30th day and on the 90th day
Time frame: three month
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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