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

NCT07646743 | Completed

• 1 other identifier: 2025/19
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Polyneuropathy; Sleep Hygiene; Pain

Keywords

Diabetic Polyneuropathy; Sleep Hygiene; Pain; Quality of Life; Sleep Quality

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Other: Control

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.

Other: sleep hygiene education

Interventions

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.

sleep hygiene education

Control OTHER

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

control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients diagnosed with Type 1 diabetes
• Multiple Sclerosis patients who do not volunteer to participate in the study

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Medical Research and Application Centre

Merkez, Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Sleep Hygiene; Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Health Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Ayfer Gunes, PhD, RN.

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. (PhD), Register Nurse

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 15, 2026
• Study Start: January 7, 2025
• Primary Completion: January 15, 2026
• Study Completion: February 1, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)