Digital Stimulation and Anxiety and Sleep Quality in Intensive Care Unit Patients
11 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
70
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Esra Başer Akın
- Numéro de téléphone: +90 538 478 06 60
- E-mail: esra_baser568@hotmail.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
|
Visually, they will be shown landscape images on a tablet.
Simultaneously, they will listen to classical music (60-80 bpm) through headphones.
|
|
Aucune intervention: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Richards-Campbell Sleep Questionnaire (RCSQ)
Délai: 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.
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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.
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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)
Délai: 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.
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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.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
Liens utiles
- Karaman Özlü, Z., & Özer, N. (2015). Richard-Campbell Uyku Ölçeği geçerlilik ve güvenirlik çalışması. Türk Uyku Tıbbı Dergisi, 2(2), 29-32
- Aydemir, Ö., Güvenir, T., Küey, L., & Kültür, S. (1997). Hastane Anksiyete ve Depresyon Ölçeği Türkçe formunun geçerlilik ve güvenilirliği. Türk Psikiyatri Dergisi, 8(4), 280-287.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
14 septembre 2026
Achèvement primaire (Estimé)
14 février 2027
Achèvement de l'étude (Estimé)
21 février 2027
Dates d'inscription aux études
Première soumission
6 septembre 2026
Première soumission répondant aux critères de contrôle qualité
11 septembre 2026
Première publication (Réel)
15 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12.08.2026-50534
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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Non
Étudie un produit d'appareil réglementé par la FDA américaine
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