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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Other | 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. |
|
| sleep hygiene education | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sleep hygiene education | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | three month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayfer Gunes, PhD, RN. | Trakya University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trakya University Medical Research and Application Centre | Merkez | Edirne | 22030 | Turkey (Türkiye) |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D000070263 | Sleep Hygiene |
| D010146 | Pain |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| Control | Other | Participants in the control group continued with their routine treatment and care; no additional educational intervention was provided during this period. |
|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |