"The Effect of Sleep Hygiene Training Given to Heart Failure Patients on Their HospitalAcquired Insomnia Level"

March 23, 2025 updated by: Muş Alparslan University

"The Effect of Sleep Hygiene Training Given to Heart Failure Patients on Their HospitalAcquired Insomnia Level": Randomized Controlled Trial

The purpose of this study is to examine the effect of sleep hygiene education given to heart failure patients on the level of hospital-acquired insomnia of the patients. Participants will be randomly assigned to groups as experimental and control groups. Standard application procedure will be applied to the control group. Sleep hygiene education will be given to the experimental group.

Research Hypotheses H0: Sleep hygiene education given to heart failure patients does not have a positive effect on the level of hospital-acquired insomnia of the patients.

H1: Sleep hygiene education given to heart failure patients has a positive effect on the level of hospital-acquired insomnia of the patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Heart failure (HF) is a life-threatening health problem. HF is considered a public health burden when the incidence, prevalence, healthcare expenditures, morbidity, mortality and poor quality of life are considered. Heart failure is prevalent in 6.5 million people in the United States, approximately 900,000 people are discharged from the hospital and more than 78,000 people die each year. HF, which has a high mortality and morbidity rate, has many symptoms. HF patients experience various physical and emotional complaints such as dyspnea, fatigue, edema, sleep disorders, depression and chest pain. Pharmacological and non-pharmacological treatment methods are used to improve sleep quality in chronic diseases. However, the inadequacy of pharmacological treatment methods and the fact that they cause various problems have brought non-pharmacological treatment methods to the forefront. One of the most frequently used methods in the non-pharmacological treatment of sleep problems is sleep hygiene training. The concept of sleep hygiene was first used by Peter Hauri. Sleep hygiene aims to provide behaviors that will ensure good sleep by avoiding individual behaviors that disrupt normal sleep patterns. The purpose of this study is to examine the effect of sleep hygiene education given to heart failure patients on the level of hospital-acquired insomnia of the patients. Participants will be randomly assigned to groups as experimental and control groups. Standard application procedure will be applied to the control group. Sleep hygiene education will be given to the experimental group.

Research Hypotheses H0: Sleep hygiene education given to heart failure patients does not have a positive effect on the level of hospital-acquired insomnia of the patients.

H1: Sleep hygiene education given to heart failure patients has a positive effect on the level of hospital-acquired insomnia of the patients.

Study Type

Interventional

Enrollment (Estimated)

34

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

      • Erzurum, Turkey, 04100
        • Atatürk University Research Hospital
        • Sub-Investigator:
          • Burak YAVUZ, Specialist
        • Sub-Investigator:
          • Bahar ÇİFTÇİ, Associate Professor
        • Sub-Investigator:
          • Hanım Duru YÜCE BAŞARAN, Specialist
        • Sub-Investigator:
          • Dilara KOÇYİĞİT, Specialist
        • Contact:
        • Principal Investigator:
          • Güzel Nur YILDIZ, Dr
        • Sub-Investigator:
          • Gamze Koç, Specialist

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:

  • Being over 18 years old
  • Being literate
  • Being a heart failure patient
  • Being hospitalized for at least 1 week and staying for another week
  • Not having a condition that prevents verbal communication
  • Not having a diagnosed psychiatric problem
  • Being a volunteer to participate in the research

Exclusion Criteria:

  • Having a verbal communication disability
  • Having a diagnosed psychiatric problem

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: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Sleep hygiene education will be given to the experimental group.
A structured training booklet will be prepared to ensure sleep hygiene for individuals. In addition, sleep hygiene training will be provided to individuals.
No Intervention: Control Group
Standard application procedure will be applied to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital-acquired insomnia
Time Frame: 1 months
Insomnia Score Average
1 months

Collaborators and Investigators

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

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 (Estimated)

June 30, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

March 23, 2025

First Submitted That Met QC Criteria

March 23, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • muş alp

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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