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NCT Number: NCT07135921

Sleep Hygiene Education in Individuals With Cardiovascular Disease: Effects on Sleep Quality and Disease Management

This clinical trial aims to find out if sleep hygiene education helps people with cardiovascular disease manage their illness better and improve their sleep quality.

Participants will be randomly assigned to two groups. One group will receive sleep hygiene education through a 30-minute presentation and twice-daily reminder messages for four weeks. The other group will receive usual care without education.

Before and after the four-week period, all participants will complete questionnaires about their sleep habits, sleep quality, and disease management.

The study hopes to show that sleep hygiene education can improve participants' sleep and help them manage their disease symptoms better, leading to a better quality of life.

The trial will take place at Near East University Hospital's Cardiology Department from June to December 2025.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older
  • Clinical diagnosis of cardiovascular disease at least one year prior
  • No visual, hearing, communication, cognitive, or physical impairments
  • Literate and able to use a smartphone and/or computer
  • Willing to participate in the sleep hygiene education program
  • Able to provide informed consent

Exclusion criteria

  • Pregnancy
  • Working night shifts
  • Cognitive impairment preventing questionnaire completion
  • Visual, hearing, communication, or physical impairments that prevent participation

Treatment and study plan

Sleep Hygiene Education

Behavioral

This intervention consists of a nurse-led sleep hygiene education program delivered through a 30-minute PowerPoint presentation. Participants in the intervention group will also receive twice-daily reminder messages via WhatsApp for four weeks to reinforce healthy sleep habits. The program aims to improve sleep quality and disease management in individuals with cardiovascular disease. After the study, the educational materials will also be shared with the control group.

Primary outcomes

  1. Improvement in Sleep Quality

    Time frame: 5 weeks (4 weeks intervention + final assessment in week 5)

    This outcome measures the change in participants' sleep quality after the 4-week sleep hygiene education program. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score ranges from 0 to 21, where higher scores indicate worse sleep quality and lower scores indicate better sleep quality. Data will be collected at baseline and after completion of the intervention.

Secondary outcomes

  1. Improvement in Disease Management

    Time frame: 5 weeks (4 weeks intervention + final assessment in week 5)

    This outcome measures the change in participants' disease self-management ability after the 4-week sleep hygiene education program. Disease management will be assessed using the Chronic Disease Self-Management Scale (CDSMS). The CDSMS total score ranges from 0 to 100, with higher scores indicating better self-management and lower scores indicating poorer self-management. Data will be collected at baseline and after completion of the intervention.

Sponsors and collaborators

Lead sponsor

Near East University, Turkey

Other

Registry information

Official study title

The Effect of Sleep Hygiene Education on Disease Management and Sleep Quality in Individuals With Cardiovascular Diseases: A Randomized Controlled Clinical Trial Protocol

Acronym: SLEEP-CARD

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2025
Registry last updated
Aug 24, 2025

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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