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

NCT07135921 | Not Yet Recruiting

• 2 other identifiers: YDU-KARD-UYKU-2025-RCTNear East University
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiovascular Disease and Sleep Hygiene

Outcome Measures

Primary Outcomes (1)

• Improvement in Sleep Quality

  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.

  5 weeks (4 weeks intervention + final assessment in week 5)

Secondary Outcomes (1)

• Improvement in Disease Management

  5 weeks (4 weeks intervention + final assessment in week 5)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Behavioral: Sleep Hygiene Education

Control

NO INTERVENTION

Interventions

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.

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Near East University, Turkey: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Sleep Hygiene

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

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. Deniz Talaz, PhD, Principal Investigator, Department of Medical Nursing, Near East University

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 22, 2025
• Study Start: September 11, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 30, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08