Diabetic Polyneuropathy, Pain, Sleep Hygiene
Conditions
Keywords
Diabetic Polyneuropathy, Sleep Hygiene, Pain, Quality of Life, Sleep Quality
Brief summary
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.
Detailed description
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
Interventions
OTHERsleep 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.
OTHERControl
Participants in the control group continued with their routine treatment and care; no additional educational intervention was provided during this period.
Sponsors
Trakya University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with type 2 diabetes * Patients confirmed diagnosis of diabetic polyneuropathy * Patients not having any other illness besides diabetic polyneuropathy * Patients not receiving treatment for diabetic polyneuropathy * Patients with Multiple Sclerosis who volunteer to participate in the study
Exclusion criteria
* Patients diagnosed with Type 1 diabetes * Multiple Sclerosis patients who do not volunteer to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of sleep score | tree month | 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 |
| Quality of life score | three month | Change in the mean scores of the SF-12 Health Survey at the first interview, on the 30th day and on the 90th day |
| Pain inventory score | three month | Change in the mean scores of the Brief Pain Inventory (BPI) at the first interview, on the 30th day and on the 90th day |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORAyfer Gunes, PhD, RN.
Trakya University
Outcome results
None listed