- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07820839
Digital Stimulation and Anxiety and Sleep Quality in Intensive Care Unit Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Esra Başer Akın
- Phone Number: +90 538 478 06 60
- Email: esra_baser568@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Visually, they will be shown landscape images on a tablet.
Simultaneously, they will listen to classical music (60-80 bpm) through headphones.
|
|
No 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Richards-Campbell Sleep Questionnaire (RCSQ)
Time Frame: 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)
Time Frame: 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.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
Helpful Links
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12.08.2026-50534
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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