- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06900504
"The Effect of Sleep Hygiene Training Given to Heart Failure Patients on Their HospitalAcquired Insomnia Level"
"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
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey, 04100
- Atatürk University Research Hospital
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Sub-Investigator:
- Burak YAVUZ, Specialist
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Sub-Investigator:
- Bahar ÇİFTÇİ, Associate Professor
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Sub-Investigator:
- Hanım Duru YÜCE BAŞARAN, Specialist
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Sub-Investigator:
- Dilara KOÇYİĞİT, Specialist
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Contact:
- Eda Ay, Dr
- Phone Number: 04423446666
- Email: memnuniyet@atauni.edu.tr
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Principal Investigator:
- Güzel Nur YILDIZ, Dr
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Sub-Investigator:
- Gamze Koç, Specialist
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Heart Failure
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-
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-
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-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
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