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

NCT07820839 | Not Yet Recruiting

• 1 other identifier: 12.08.2026-50534
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

ICU Patients

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  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.

Study Arms (2)

Intervention Group: Digital Visual and Auditory Stimulation

EXPERIMENTAL

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

Control Group: Usual Care

NO INTERVENTION

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

Digital Visual and Auditory Stimulation OTHER

Visually, they will be shown landscape images on a tablet. Simultaneously, they will listen to classical music (60-80 bpm) through headphones.

Intervention Group: Digital Visual and Auditory Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cumhuriyet University: lead

Related Publications (2)

• Richards K. Techniques for measurement of sleep in critical care. Focus Crit Care. 1987 Aug;14(4):34-40. No abstract available.

  PMID: 3650169 BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

Related 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.

MeSH Terms

Interventions

Acoustic Stimulation

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques

Central Study Contacts

Esra Başer Akın

CONTACT

+90 538 478 06 60; esra_baser568@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 15, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 21, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share