Effect of a Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies on Sleep Quality Among Patients With Chronic Heart Failure

NCT07747597 | Completed DMC

• 1 other identifier: ERCNMA 1000 / 68 / 163 / 25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of a structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies on improving sleep quality among patients with chronic heart failure. Sleep disturbances are common in patients with chronic heart failure and are associated with poorer functional status, reduced quality of life, and increased healthcare utilization. Participants will receive a structured nursing intervention that includes education on healthy sleep practices and cognitive-behavioral techniques to improve sleep.

Conditions

Chronic Heart Failure (CHF)

Keywords

Chronic Heart Failure, Sleep Quality, Sleep Hygiene, Cognitive-Behavioral Strategies

Outcome Measures

Primary Outcomes (1)

• Sleep Quality

  Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated self-reported questionnaire that measures subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Higher global PSQI scores indicate poorer sleep quality.

  Baseline and 3 months after completion of the intervention.

Study Arms (2)

Structured Nursing Intervention

EXPERIMENTAL

Participants receive the structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies in addition to usual care.

Behavioral: Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies

Routine Care

NO INTERVENTION

Participants assigned to the control arm will receive the standard care routinely provided for patients with chronic heart failure, including routine medical management, nursing care, and follow-up according to hospital practice. They will not receive the structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies.

Interventions

Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies BEHAVIORAL

Participants assigned to the intervention group will receive a structured nurse-led program consisting of sleep hygiene education and cognitive-behavioral strategies in addition to usual care. The intervention includes education on healthy sleep practices, establishing regular sleep schedules, optimizing the sleep environment, relaxation techniques, cognitive restructuring of maladaptive beliefs about sleep, stimulus control, and behavioral strategies to improve sleep quality. The program is delivered through structured educational sessions and follow-up support according to the study protocol.

Structured Nursing Intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 to 65 years.
• Diagnosed with chronic heart failure for at least 6 months according to the New York Heart Association (NYHA) classification.
• Experiencing poor sleep quality as indicated by a score \>5 on the Pittsburgh Sleep Quality Index during the previous month.

You may not qualify if:

• Patients with diagnosed psychiatric disorders or severe cognitive impairment.
• Patients receiving sedative-hypnotic therapy initiated within the previous month.
• Patients diagnosed with obstructive sleep apnea requiring continuous positive airway pressure therapy.
• Patients participating in other behavioral intervention program

Sponsors & Collaborators

• Al-Zaytoonah University of Jordan: lead

Study Sites (1)

Al zaytoonah University

Amman, 00000, Jordan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Hygiene

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcome assessors will be blinded to participants' group allocation to minimize assessment bias. Participants and the nurses delivering the intervention cannot be blinded because of the nature of the educational and behavioral intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Participants will be randomly assigned to one of two parallel groups. The intervention group will receive a structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies in addition to usual care, while the control group will receive usual care alone. Outcomes will be assessed at baseline and after completion of the intervention to compare changes in sleep quality between the two groups.

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: June 8, 2025
• Primary Completion: December 5, 2025
• Study Completion: April 7, 2026
• Last Updated: August 5, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)