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DyspneaNCT07895030

Visual and Auditory Stimulation in Intensive Care Patients

A study testing The Northern Lights and White Noise in people with Dyspnea and Sleep Quality, run by University of Yalova.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Dyspnea, Sleep Quality, Anxiety
What is being tested?
The Northern Lights and White Noise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
No sites listed yet
Study dates
1 Nov 2026to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

NİRAN ÇOBAN, Asst. prof. contact

05301586912

nirancoban@gmail.com

Sena BATTAL, RN contact

senabattal18@gmail.com

About this study

Official title: The Effect of Visual and Auditory Stimulation on Dyspnea, Sleep Quality, and Anxiety Levels in Intensive Care Patients

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.

Being tested
The Northern Lights and White Noise
Medical subject headings
Dyspnea, Sleep Initiation and Maintenance Disorders, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Northern Lights and White NoiseOther

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

Study groups in NCT07895030
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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.
Receives: Other: The Northern Lights and White Noise
Standard careNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 2 month

Secondary outcomes (1)
  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.

    Measured: 2 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07895030
Sponsor's protocol ID
SBNC
Status last verified
Oct 2026
First submitted
18 Oct 2026
Last updated
26 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing The Northern Lights and White Noise in people with Dyspnea and Sleep Quality, run by University of Yalova.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact NİRAN ÇOBAN, Asst. prof. (05301586912, nirancoban@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Northern Lights and White Noise on Dyspnea: Dyspnea-12 (D-12) (time frame: 2 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07895030, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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