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NCT Number: NCT07646743

The Effect of Sleep Hygiene Education on Sleep Quality and Quality of Life in Patients With Painful Diabetic Polyneuropathy

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.

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Key information

Conditions

Diabetic Polyneuropathy Behavior Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Dyssomnias Endocrine System Diseases Health Behavior Mental Disorders Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Sleep Disorders, Intrinsic Sleep Hygiene Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trakya University Medical Research and Application Centre

Merkez, Edirne, 22030, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control

Other

Participants in the control group continued with their routine treatment and care; no additional educational intervention was provided during this period.

Primary outcomes

  1. Quality of sleep score

    Time frame: 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

  2. Quality of life score

    Time frame: 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

  3. Pain inventory score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

Ağrılı Diyabetik Polinöropatili Hastalara Verilen Uyku Hijyeni Eğitiminin Uyku Kalitesi Ve Yaşam Kalitesi Üzerine Etkisi

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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