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Digital Stimulation and Anxiety and Sleep Quality in Intensive Care Unit Patients

11. September 2026 aktualisiert von: Esra Baser Akin, Cumhuriyet University

The Effect of Digital Visual and Auditory Stimulation on Anxiety and Sleep Quality in Patients Hospitalized in the Intensive Care Unit: A Randomized Controlled Trial

The aim of this study is to examine the effect of digital visual and auditory stimulation on anxiety and sleep quality in patients hospitalized in the intensive care unit (ICU).

The questions to be answered within the scope of the research are:

Does the application of digital visual and auditory stimulation to patients in intensive care units have a significant effect on anxiety levels? Does the application of digital visual and auditory stimulation to patients in intensive care units have a significant effect on sleep quality? Does the application of digital visual and auditory stimulation to patients in intensive care units have a combined effect on anxiety levels and sleep quality?

Participants will:

The patients will be divided into two groups: an intervention group and a control group. The intervention group will receive visual and auditory stimuli once a day, every morning for three days. Sleep quality and anxiety levels will be measured after the digital visual and auditory stimuli.

The control group will continue with routine intensive care unit follow-up treatments.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Patients in the intervention group will be administered a questionnaire, the Richards-Campbell Sleep Scale, and the Hospital Anxiety and Depression Scale as pre-tests. Following this, for three consecutive days, the research nurse will show the patient nature images (landscapes, lakes, mountains, etc.) via tablet for approximately 20-30 minutes once a day in the mornings when the patient is available. While watching the images, Johann Sebastian Bach's instrumental classical music pieces (60-80 bpm) will be played through headphones. The pieces to be used as digital visual and auditory stimuli will be selected by the art therapy specialist in the study. During the intervention, patients' vital signs and clinical condition will be closely monitored, and the intervention will be terminated if any discomfort, hemodynamic instability, or intolerance to the procedure develops. The digital visual and auditory stimulus application will continue under the same conditions for three days, and at the end of the third day, the Richards-Campbell Sleep Scale and the Hospital Anxiety and Depression Scale will be administered again as post-tests. Control Group Patients in the control group will also be administered the Demographic Information Form, the Richards-Campbell Sleep Scale (RCSQ), and the Hospital Anxiety and Depression Scale (HADS) at the beginning of the data collection process, at the same time as the intervention group. Patients in the control group will not undergo any intervention during the study period, and their routine intensive care treatment and care will continue. At the end of the third day, the Richards-Campbell Sleep Scale and the Hospital Anxiety and Depression Scale will be administered again as a final test, simultaneously with the intervention group.

Studientyp

Interventionell

Einschreibung (Geschätzt)

70

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • 18 years and above
  • Conscious [Glasgow Coma Scale(GCS)] ≥ 14)
  • Not connected to mechanical ventilation or receiving non-invasive support
  • Hearing and visual functions are sufficient
  • No communication problems
  • Able to answer questions correctly
  • Not under sedation
  • Expected to stay in the ICU for at least 48 hours

Exclusion Criteria:

  • Having a hearing or visual impairment
  • Being under sedation
  • Having impaired consciousness
  • Refusing to participate in the study

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Intervention Group: Digital Visual and Auditory Stimulation
Patients in the intervention group will receive visual and auditory stimuli once a day, every morning for three days. Visually, they will be shown landscape images on a tablet. Simultaneously, they will listen to classical music (60-80 bpm) through headphones. As a pre-test, patients in the intervention group will complete a questionnaire, the Richards-Campbell Sleep Scale, and the Hospital Anxiety and Depression Scale. These scales will also be administered as a post-test on the third day.
Sonstiges: Digital Visual and Auditory Stimulation
Visually, they will be shown landscape images on a tablet. Simultaneously, they will listen to classical music (60-80 bpm) through headphones.
Kein Eingriff: Control Group: Usual Care
Patients in the control group will also be administered the Richards-Campbell Sleep Scale (RCSQ) and the Hospital Anxiety and Depression Scale (HADS) at the beginning of the data collection process, at the same time as the intervention group. Patients in the control group will not receive any intervention during the study; their routine intensive care treatment and care will continue. The scales will be administered simultaneously with the intervention group at the end of the third day.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Richards-Campbell Sleep Questionnaire (RCSQ)
Zeitfenster: The sleep questionnaire will be administered upon admission to the intensive care unit on the first day of the study and at the end of the third day of the intervention.
The Richard-Campbell Sleep Scale (RCSS) is a scale developed by Richards in 1987 to assess the quality of nocturnal sleep in patients. Adapted into Turkish by Özlü and Özer, and subsequently validated and its reliability studied, the scale consists of six items that evaluate the depth of nocturnal sleep, time to fall asleep, frequency of awakenings, duration of wakefulness, quality of sleep, and ambient noise level. Each item is evaluated on a visual analog scale ranging from 0 to 100. A score of "0-25" indicates very poor sleep, while a score of "76-100" indicates very good sleep. As the scale score increases, the patients' sleep quality also improves. The Cronbach's α value of the scale was determined to be 0.82.
The sleep questionnaire will be administered upon admission to the intensive care unit on the first day of the study and at the end of the third day of the intervention.
Hospital Anxiety and Depression Scale (HADS)
Zeitfenster: The scale will be administered as a first test during the initial interview at the beginning of the study and as a final test during the final interview at the end of the third day.
Developed by Zigmond and Snaith (1983) to determine a patient's risk of anxiety and depression, and to measure their level and severity, the scale's validity and reliability in Turkish were established by Aydemir et al. (1997). The scale contains 14 questions in total, with odd numbers measuring anxiety and even numbers measuring depression. The scale consists of two subscales: Anxiety (HAD-A) and Depression (HAD-D). In the validity and reliability study, the cutoff score for HAD-A was found to be 10/11, and for HAD-D, 7/8. Accordingly, scores above these points are considered at risk. The scale is a four-point Likert type, with a total score ranging from 0 to 42.
The scale will be administered as a first test during the initial interview at the beginning of the study and as a final test during the final interview at the end of the third day.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Cumhuriyet University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

14. September 2026

Primärer Abschluss (Geschätzt)

14. Februar 2027

Studienabschluss (Geschätzt)

21. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

6. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. September 2026

Zuerst gepostet (Tatsächlich)

15. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 12.08.2026-50534

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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