- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07755280
Predictors of Sleep Quality in Patients Undergoing Open-Heart Surgery
5. august 2026 oppdatert av: Ezgi Arslan, Aydin Adnan Menderes University
Predictors of Sleep Quality in Patients Undergoing Open-Heart Surgery: A Hierarchical Regression Analysis
Sleep quality is a complex and multidimensional phenomenon shaped by the interaction of patient characteristics, symptom burden, and environmental factors specific to the intensive care unit environment.
Despite this multidimensional nature, studies identifying predictors of sleep quality in intensive care units after cardiac surgery are limited.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
Sleep is a fundamental biological process necessary for maintaining physiological homeostasis, supporting immune function, and promoting healing.
Sleep quality is a multidimensional construct influenced by individual characteristics such as age and body mass index, as well as psychological factors like stress and anxiety, and environmental factors such as noise, light, lack of privacy, and care practices.
However, patients in intensive care units often experience poor sleep quality, characterized by reduced sleep duration, fragmented sleep, prolonged sleep latency, and frequent awakenings.
Poor sleep quality in intensive care units leads to a higher incidence of delirium and atrial fibrillation complications in patients during the postoperative period, delayed recovery time, negative impact on immune function, and prolonged stay in the intensive care unit.
Open heart surgery is a frequently performed operation in ischemic and non-ischemic heart diseases (valve diseases, aortic stenosis, and atrial septal defect, etc.) that requires close monitoring of patients in an intensive care environment after surgery.
Following these surgeries, physiological issues such as pain, surgical wound problems, fatigue, dyspnea, and sleep problems commonly experienced by patients in intensive care settings, and psychological issues such as anxiety, stress, fear of death negatively affect sleep quality.
In addition, individual characteristics such as age and body mass index (BMI) can also affect sleep quality in this patient population.
Poor sleep quality in intensive care units is a commonly reported problem by patients, but due to its multifaceted nature, it is often not effectively managed.
Although previous studies have reported the prevalence of sleep disorders in intensive care patients, most studies have failed to adopt a comprehensive and multifactorial approach that examines the variables affecting sleep quality individually.
This situation highlights the need for studies using multivariate analytical methods to identify independent predictors of sleep quality.
The aim of this study is to examine the predictors of sleep quality in patients undergoing open heart surgery and admitted to the cardiovascular surgery intensive care unit, using a multivariate approach.
Studietype
Observasjonsmessig
Registrering (Faktiske)
157
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Zafer Mahallesi
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Aydin, Zafer Mahallesi, Tyrkia (Türkiye), 09010
- Aydın Adnan Menderes University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients admitted to the cardiovascular intensive care unit after open heart surgery
Beskrivelse
Inclusion Criteria:
- ability to understand and speak Turkish,
- willingness to participate in the study,
- having spent at least 24 hours in the intensive care unit, and
- having the cognitive ability to understand and answer questions.
Exclusion Criteria:
- having taken narcotic or sedative drugs within the last 48 hours,
- having a history of chronic diseases that can cause sleep problems such as Chronic Obstructive Pulmonary Disease or sleep apnea,
- having a psychiatric illness diagnosed by a physician,
- having a visual or hearing impairment.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain
Tidsramme: At least 24 hours after admission to the intensive care unit
|
Assessed wit Visual Analog Scale.
his scale is a unidimensional, self-report instrument measuring 10 cm in length.
The lower end corresponds to a score of 0, labeled 'no pain,' while the upper end corresponds to a score of 10, labeled 'unbearable pain.' Higher scores on the scale indicate greater severity of pain as reported by the patient.
|
At least 24 hours after admission to the intensive care unit
|
|
Sleep quality
Tidsramme: At least 24 hours after admission to the intensive care unit
|
Assessed with Richard- Campbell Sleep Questionnaire. he scale consists of 6 items assessing sleep quality, nocturnal sleep depth, frequency of awakening, ambient noise level, time spent awake, and sleep onset latency.
Each item is rated on a visual analog scale ranging from 0 to 100.
The total score obtained from the scale is divided by the number of items to calculate the scale score.
A scale score between 0 and 25 is interpreted as very poor sleep, while a score between 76 and 100 is interpreted as very good sleep.
|
At least 24 hours after admission to the intensive care unit
|
|
Fatigue
Tidsramme: At least 24 hours after admission to the intensive care unit
|
Assessed wit Visual Analog Scale.
his scale is a unidimensional, self-report instrument measuring 10 cm in length.
The lower end corresponds to a score of 0, labeled 'no fatigue,' while the upper end corresponds to a score of 10, labeled 'unbearable fatigue.'
Higher scores on the scale indicate greater severity of fatigue as reported by the patient.
|
At least 24 hours after admission to the intensive care unit
|
|
Environmental Stressors
Tidsramme: At least 24 hours after admission to the intensive care unit
|
Assessed with Intensive Care Unit Environmental Stressors Scale.
The scale is of a 4-point Likert type and consists of 42 items.
The minimum possible score is 42 and the maximum is 168.
Higher scores are interpreted as indicating a greater degree of being affected by environmental stressors.
|
At least 24 hours after admission to the intensive care unit
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. september 2025
Primær fullføring (Faktiske)
15. mars 2026
Studiet fullført (Faktiske)
15. mai 2026
Datoer for studieregistrering
Først innsendt
5. august 2026
Først innsendt som oppfylte QC-kriteriene
5. august 2026
Først lagt ut (Faktiske)
10. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Predictors of Sleep Quality
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD-delingstidsramme
12 months after publication
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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