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

June 12, 2026 updated by: AYFER GUNES, Trakya University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Edirne
      • Merkez, Edirne, Turkey (Türkiye), 22030
        • Trakya University Medical Research and Application Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control
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
Participants in the control group continued with their routine treatment and care; no additional educational intervention was provided during this period.
Experimental: sleep hygiene education
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
tree month
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
three month
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
three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trakya University

Investigators

  • Principal Investigator: Ayfer Gunes, PhD, RN., Trakya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2025

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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