Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-30 @ 1:12 AM
Study NCT ID:
NCT06900504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-28
First Post:
2025-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"The Effect of Sleep Hygiene Training Given to Heart Failure Patients on Their HospitalAcquired Insomnia Level"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-23', 'studyFirstSubmitDate': '2025-03-23', 'studyFirstSubmitQcDate': '2025-03-23', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital-acquired insomnia', 'timeFrame': '1 months', 'description': 'Insomnia Score Average'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': '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.\n\nResearch 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.\n\nH1: Sleep hygiene education given to heart failure patients has a positive effect on the level of hospital-acquired insomnia of the patients.', 'detailedDescription': '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.\n\nResearch 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.\n\nH1: Sleep hygiene education given to heart failure patients has a positive effect on the level of hospital-acquired insomnia of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over 18 years old\n* Being literate\n* Being a heart failure patient\n* Being hospitalized for at least 1 week and staying for another week\n* Not having a condition that prevents verbal communication\n* Not having a diagnosed psychiatric problem\n* Being a volunteer to participate in the research\n\nExclusion Criteria:\n\n* Having a verbal communication disability\n* Having a diagnosed psychiatric problem'}, 'identificationModule': {'nctId': 'NCT06900504', 'briefTitle': '"The Effect of Sleep Hygiene Training Given to Heart Failure Patients on Their HospitalAcquired Insomnia Level"', 'organization': {'class': 'OTHER', 'fullName': 'Muş Alparslan University'}, 'officialTitle': '"The Effect of Sleep Hygiene Training Given to Heart Failure Patients on Their HospitalAcquired Insomnia Level": Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'muş alp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Sleep hygiene education will be given to the experimental group.', 'interventionNames': ['Other: Sleep hygiene education']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Standard application procedure will be applied to the control group.'}], 'interventions': [{'name': 'Sleep hygiene education', 'type': 'OTHER', 'description': 'A structured training booklet will be prepared to ensure sleep hygiene for individuals. In addition, sleep hygiene training will be provided to individuals.', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04100', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Eda Ay, Dr', 'role': 'CONTACT', 'email': 'memnuniyet@atauni.edu.tr', 'phone': '04423446666'}, {'name': 'Güzel Nur YILDIZ, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gamze Koç, Specialist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hanım Duru YÜCE BAŞARAN, Specialist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Burak YAVUZ, Specialist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bahar ÇİFTÇİ, Associate Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dilara KOÇYİĞİT, Specialist', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Atatürk University Research Hospital', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muş Alparslan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}