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Predictors of Sleep Quality in Patients Undergoing Open-Heart Surgery

5 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

157

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Zafer Mahallesi
      • Aydin, Zafer Mahallesi, Turkije (Türkiye), 09010
        • Aydın Adnan Menderes University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients admitted to the cardiovascular intensive care unit after open heart surgery

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 september 2025

Primaire voltooiing (Werkelijk)

15 maart 2026

Studie voltooiing (Werkelijk)

15 mei 2026

Studieregistratiedata

Eerst ingediend

5 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 augustus 2026

Eerst geplaatst (Werkelijk)

10 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

5 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

IPD-tijdsbestek voor delen

12 months after publication

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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