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Not yet recruitingNCT07895030Updated Oct 26, 2026

Visual and Auditory Stimulation in Intensive Care Patients

An interventional study of The Northern Lights and White Noise in Dyspnea, Sleep Quality and Anxiety, sponsored by University of Yalova. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by University of Yalova · Not applicable, Interventional, and Supportive care

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study is a randomized controlled experimental clinical trial designed to investigate the effects of visual and auditory stimulation on dyspnea severity, sleep quality, and anxiety levels in patients receiving noninvasive mechanical ventilation (NIMV) support in a secondary-level cardiac intensive care unit. A total of 44 patients (22 in the intervention group, 22 in the control group) are planned to be included in the study. Patients in the intervention group will be exposed to images of the Northern Lights projected onto the ceiling and white noise simultaneously for 30 minutes each night over two nights. The control group will receive no intervention other than routine nursing care. Data will be collected using the Dyspnea-12 Scale, the State Anxiety Inventory, the Richards-Campbell Sleep Scale, and a physiological parameters form. The study results are expected to contribute to evidence-based practices aimed at reducing dyspnea and anxiety, improving sleep quality, and enhancing patient comfort in intensive care patients through non-pharmacological methods.

Read the detailed description

Intensive care units (ICUs) are clinical settings where critically ill patients receive treatment and care. The use of advanced medical technology and exposure to environmental stressors may increase patients' physical and psychological stress. Patients receiving non-invasive mechanical ventilation (NIMV) may experience dyspnea, anxiety, and sleep disturbances due to respiratory failure, discomfort caused by the face mask, air pressure delivered by the device, and environmental factors. These problems may adversely affect patient comfort, treatment adherence, and overall well-being. Therefore, non-pharmacological interventions are needed to support patient comfort while minimizing potential complications associated with pharmacological treatments.

The aim of this study is to investigate the effects of visual and auditory stimulation on dyspnea severity, sleep quality, and anxiety levels in patients receiving NIMV support in a secondary-level chest intensive care unit. In this study, Northern Lights projections displayed on the ceiling will be used as the visual stimulus, and white noise will be used as the auditory stimulus. These interventions are expected to promote relaxation by diverting patients' attention from environmental stressors in the ICU, thereby potentially reducing dyspnea and anxiety and improving sleep quality.

This study is planned as a randomized controlled experimental clinical trial. It will be conducted in the Secondary-Level Chest Intensive Care Unit of Sancaktepe Prof. Dr. Feriha Öz Emergency Hospital, following the acquisition of the required ethics committee approval and institutional permissions. Data collection is planned between June 2026 and June 2027. A total of 44 patients aged 18 years or older are planned to be included. Eligible participants will be conscious, fully oriented, cooperative, receiving NIMV support, and willing to participate in the study. Participants will be allocated to an intervention group (n = 22) or a control group (n = 22).

Patients in the intervention group will receive simultaneous visual and auditory stimulation for 30 minutes on two consecutive nights. During each session, Northern Lights images will be projected onto the ceiling, while white noise will be played through a speaker. On the first night, dyspnea severity and state anxiety will be assessed immediately before and after the intervention. Sleep quality will be evaluated at 08:00 the following morning. On the second night, assessments of dyspnea and anxiety will again be performed before and after the intervention. Sleep quality will be reassessed at 08:00 on the following morning. Patients in the control group will receive routine nursing care without the additional intervention and will undergo the same assessments according to the study protocol.

Data will be collected using a Patient Identification and Clinical Data Form, the Dyspnea-12 Scale, the State-Trait Anxiety Inventory (state anxiety subscale), the Richards-Campbell Sleep Questionnaire, and a Physiological Parameters Form. Patients' blood pressure, heart rate, and oxygen saturation values will also be recorded. Statistical analyses will be performed using appropriate descriptive and comparative tests, with statistical significance set at p \< 0.05.

The findings are expected to provide evidence regarding the potential effects of combined visual and auditory stimulation in patients receiving NIMV support in intensive care settings. The study may contribute to the development of evidence-based, patient-centered, non-pharmacological nursing interventions. If the intervention is found to be effective, it may provide a basis for practical care strategies designed to improve patient comfort in intensive care units.

02

Conditions studied

  • Dyspnea
  • Sleep Quality
  • Anxiety
  • Intensive Care Patients
03

In context

Dyspnea

681 studies on the registry are indexed under Dyspnea; 159 are open to participants now.

This study's planned enrollment of 44 is close to the median of 48 across 447 interventional studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

University of Yalova is the lead sponsor of 60 studies on the registry; 21 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 of age or older
  • Fully conscious, oriented, and cooperative (Glasgow Coma Scale: 15)
  • Receiving NIMV support
  • Individuals without severe hearing or vision loss that would impair communication,
  • Individuals who volunteer to participate in the study and sign the informed consent form (or whose legal representative provides consent) will be included in the study.

Exclusion criteria

Exclusion Criteria:

    • Patients with severe hemodynamic instability,

      • Patients exhibiting severe agitation for whom NIMV mask compliance is medically impossible,
      • Patients with a diagnosed psychiatric disorder or cognitive impairment (dementia, Alzheimer's, etc.),
      • Who are under continuous sedation or receiving neuromuscular blocking agent therapy,
      • Who have a history of photosensitive epilepsy,
      • Patients whose clinical condition deteriorates during the procedure or who wish to withdraw from the study of their own accord will be excluded from the study.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Intervention group

    The intervention group will receive visual and auditory stimulation in addition to routine nursing care, consisting of Northern Lights visuals projected onto the ceiling and white noise played through a speaker for 30 minutes nightly over two consecutive nights. Dyspnea (D-12), state anxiety, blood pressure, heart rate, and SpO₂ will be assessed before and immediately after each session. Sleep quality will be assessed at 08:00 AM using the Richards-Campbell Sleep Questionnaire (RCSQ). The control group will receive routine nursing care only. Assessments will be conducted at the same time points in both groups.

    Other: The Northern Lights and White Noise

  • No intervention
    Standard care

    Participants in the standard care group will receive routine nursing care provided to patients receiving non-invasive mechanical ventilation (NIMV) in the intensive care unit. No additional visual or auditory stimulation intervention will be administered to participants in this group. Dyspnea, anxiety, physiological parameters (blood pressure, heart rate, and peripheral oxygen saturation), and sleep quality will be assessed at the same time points as those specified for the intervention group. Sleep quality will be evaluated at 08:00 AM on the morning following each study night using the Richards-Campbell Sleep Questionnaire (RCSQ). All assessments will be conducted in accordance with the study protocol while participants continue to receive routine intensive care and nursing management.

Interventions

  • OtherThe Northern Lights and White Noise

    Northern Lights visuals will be projected into the room using a device, while white noise will be played through a speaker.

06

What researchers measure

Primary outcomes

  1. Effect of Northern Lights and White Noise on Dyspnea: Dyspnea-12 (D-12)

    The Dyspnea-12 is a validated instrument used to assess the severity of dyspnea. It consists of 12 items evaluating the physical and affective dimensions of breathlessness. Dyspnea will be assessed before and immediately after each 30-minute intervention session on two consecutive nights in the intervention group and at corresponding time points in the standard care group.

    Time frame: 2 month

  2. Effect of Northern Lights and White Noise on Anxiety: State Anxiety Inventory

    The State Anxiety Inventory (STAI-S) is used to assess an individual's current level of anxiety. It consists of 20 items, with higher scores indicating greater state anxiety. Anxiety will be assessed before and immediately after each 30-minute intervention session on two consecutive nights in the intervention group and at corresponding time points in the standard care group.

    Time frame: 2 month

  3. Effect of Northern Lights and White Noise on Sleep Quality: Richards-Campbell Sleep Questionnaire (RCSQ)

    The Richards-Campbell Sleep Questionnaire is a validated instrument used to assess sleep quality in intensive care patients. It evaluates perceived sleep depth, sleep latency, awakenings, return to sleep, and overall sleep quality. Sleep quality will be assessed at 08:00 AM on the morning following each study night in both groups.

    Time frame: 2 month

  4. Effect of Northern Lights and White Noise on Pulse Rate

    Pulse rate will be recorded to evaluate physiological responses to the intervention. Measurements will be obtained before and immediately after each 30-minute intervention session on two consecutive nights in the intervention group and at corresponding time points in the standard care group.

    Time frame: 2 month

  5. Effect of Northern Lights and White Noise on Blood Pressure

    Blood Pressure rate will be recorded to evaluate physiological responses to the intervention. Measurements will be obtained before and immediately after each 30-minute intervention session on two consecutive nights in the intervention group and at corresponding time points in the standard care group.

    Time frame: 2 month

Secondary outcomes

  1. Effect of Northern Lights and White Noise on Oxygen Saturation

    Saturation will be recorded to evaluate physiological responses to the intervention. Measurements will be obtained before and immediately after each 30-minute intervention session on two consecutive nights in the intervention group and at corresponding time points in the standard care group.

    Time frame: 2 Month

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Farokhnezhad Afshar P, Bahramnezhad F, Asgari P, Shiri M. Effect of White Noise on Sleep in Patients Admitted to a Coronary Care. J Caring Sci. 2016 Jun 1;5(2):103-9. doi: 10.15171/jcs.2016.011. eCollection 2016. PubMed 27354974 ↗
  • Aghaie B, Rejeh N, Heravi-Karimooi M, Ebadi A, Moradian ST, Vaismoradi M, Jasper M. Effect of nature-based sound therapy on agitation and anxiety in coronary artery bypass graft patients during the weaning of mechanical ventilation: A randomised clinical trial. Int J Nurs Stud. 2014 Apr;51(4):526-38. doi: 10.1016/j.ijnurstu.2013.08.003. Epub 2013 Aug 29. PubMed 24035670 ↗
  • Cammarota G, Simonte R, De Robertis E. Comfort During Non-invasive Ventilation. Front Med (Lausanne). 2022 Mar 24;9:874250. doi: 10.3389/fmed.2022.874250. eCollection 2022. PubMed 35402465 ↗
  • Gezginci E, Iyigun E, Kibar Y, Bedir S. Three Distraction Methods for Pain Reduction During Cystoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain, Anxiety, and Satisfaction. J Endourol. 2018 Nov;32(11):1078-1084. doi: 10.1089/end.2018.0491. PubMed 30280915 ↗
  • Lin LW, Weng SC, Wu HS, Tsai LJ, Lin YL, Yeh SH. The Effects of White Noise on Agitated Behaviors, Mental Status, and Activities of Daily Living in Older Adults With Dementia. J Nurs Res. 2018 Feb;26(1):2-9. doi: 10.1097/JNR.0000000000000211. PubMed 29315202 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2026, 0 months later.

Of 212 non-industry interventional studies with no phase under Dyspnea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's planned 0 months is below that.

Counting every sponsor, half of 226 studies reached it within 14 months; a quarter within 6 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2026
First posted
Oct 26, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Nov 1, 2026
CompletionEst.
Dec 1, 2026
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07895030
Lead sponsor
University of Yalova
Responsible party
Niran Çoban (Asst.Prof., University of Yalova) — Principal investigator
First posted
Oct 26, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Oct 26, 2026

Study contacts

NİRAN ÇOBAN, Asst. prof.
Contact
nirancoban@gmail.com
05301586912
Sena BATTAL, RN
Contact
senabattal18@gmail.com
NİRAN ÇOBAN, Asst. prof.
study director · University of Yalova

Oversight

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

Not currently enrolling

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