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Not yet recruitingNCT07820839Updated Sep 15, 2026

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

An interventional study of Digital Visual and Auditory Stimulation in ICU Patients, sponsored by Cumhuriyet University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Cumhuriyet University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

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Conditions studied

  • ICU Patients
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In context

Lead sponsor

Cumhuriyet University is the lead sponsor of 133 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
70 participants (estimated)

Study arms

  • 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.

    Other: Digital Visual and Auditory Stimulation

  • 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.

Interventions

  • OtherDigital 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.

06

What researchers measure

Primary outcomes

  1. Richards-Campbell Sleep Questionnaire (RCSQ)

    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.

    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.

  2. Hospital Anxiety and Depression Scale (HADS)

    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.

    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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Richards K. Techniques for measurement of sleep in critical care. Focus Crit Care. 1987 Aug;14(4):34-40. No abstract available. PubMed 3650169 ↗
  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. PubMed 6880820 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07820839
Responsible party
Esra Baser Akin (Assistant Professor, Cumhuriyet University) — Principal investigator
First posted
Sep 15, 2026
Start date
Sep 14, 2026 (estimated)
Primary completion
Feb 14, 2027 (estimated)
Completion
Feb 21, 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

Esra Başer Akın
Contact
esra_baser568@hotmail.com
+90 538 478 06 60

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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