Pain ManagementPICUNCT06867523
Eye Masks and Earplugs for Delirium and Pain Prevention in Pediatric Intensive Care Unit
A study testing Eye Mask and Earplugs in people with Pain Management and Pediatric Intensive Care Unit, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical trial aims to evaluate the effect of nighttime application of eye masks and earplugs on the incidence of delirium and pain levels in pediatric intensive care unit (PICU) patients aged 6-12 years. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pain Management, Pediatric Intensive Care Unit, Non-Pharmacological Interventions
- What is being tested?
- Eye Mask and Earplugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between the ages of 6 and 12 years.
- Receiving treatment in the Pediatric Intensive Care Unit (PICU).
- Expected to stay in the intensive care unit for more than 24 hours.
- Having a Glasgow Coma Scale (GCS) score of 9 or above.
- Not receiving sedation.
Who cannot join
- Children with diagnosed intellectual, auditory, or visual impairments.
- Children with a psychiatric diagnosis.
- Patients using hearing aids.
- Patients diagnosed with brain tumors.
- Patients requiring mechanical ventilation.
- Patients using benzodiazepines or other strong sedative medications.
- Patients with an expected ICU stay of fewer than three days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Eye Masks and Earplugs on Delirium and Pain Prevention in Pediatric Intensive Care Unit Patients
This randomized controlled clinical trial aims to evaluate the effect of nighttime application of eye masks and earplugs on the incidence of delirium and pain levels in pediatric intensive care unit (PICU) patients aged 6-12 years.
Research Questions
Read more
This study seeks to answer the following key questions:
Do eye masks and earplugs reduce the incidence of delirium compared to standard nursing care in PICU patients? Do eye masks and earplugs lower pain levels compared to standard nursing care in PICU patients? Study Design
Participants will be randomly assigned to one of the following groups:
Intervention Group: Participants will wear an eye mask and earplugs from 11:00 PM to 07:00 AM for three consecutive nights.
Control Group: Participants will receive standard nursing care without any interventions.
Both groups will be assessed daily at 08:00 AM using the following standardized measures:
Cornell Pediatric Delirium Scale (to assess symptoms of confusion and disorientation) Validated faces-based pediatric pain scale via a secure telehealth platform (to measure pain levels) Glasgow Coma Scale (GCS) (to evaluate consciousness levels) Significance and Impact This study investigates the impact of reducing environmental stimuli (light and noise) on delirium incidence and pain levels in critically ill pediatric patients. The findings may contribute to the development of non-pharmacological interventions aimed at improving patient comfort and care in intensive care settings.
Data Analysis Statistical analyses will be performed using SPSS (version 27) to compare delirium incidence and pain levels between the two groups.
- Conditions
- Pain Management, Pediatric Intensive Care Unit, Non-Pharmacological Interventions, Critical Care Nursing, Pediatric Delirium
- Being tested
- Eye Mask, Earplugs
- Keywords
- Pediatric Intensive Care, Non-Pharmacological Interventions, Delirium Prevention, Pain Management, Critical Care Nursing
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye MaskOther
Participants in this group will wear an eye mask between 11:00 PM and 07:00 AM for three consecutive nights to assess its effects on delirium and pain levels in pediatric intensive care unit patients
EarplugsOther
Participants in this group will use earplugs between 11:00 PM and 07:00 AM for three consecutive nights to evaluate their effects on delirium incidence and pain levels.
| Study group | Role | What they receive |
|---|---|---|
| Eye Mask & Earplugs | Experimental | Participants in this group will use an eye mask and earplugs between 11:00 PM and 07:00 AM for three consecutive nights. The goal is to reduce environmental stimuli and evaluate the effects on delirium incidence and pain levels. Receives: Other: Eye Mask; Other: Earplugs |
| Standard Nursing Care | No intervention | Participants in this group will receive standard nursing care without the use of an eye mask or earplugs. Their delirium incidence and pain levels will be assessed under usual care conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Delirium in Pediatric ICU Patients
Delirium incidence will be assessed using the Cornell Pediatric Delirium Scale every morning at 08:00 AM for three consecutive days. The nurse rates each item of the screening questions on a scale from 0 (lowest) to 4 (highest). Scores ≥9 indicate delirium.
Measured: 3 days after intervention
Pain Levels in Pediatric ICU Patients
Pain levels will be assessed every morning at 08:00 AM for three consecutive days using a validated faces-based pediatric pain assessment tool administered via a secure telehealth platform.
Measured: 3 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start25 Aug 2024
- Primary completion30 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Participants will be randomly assigned to an intervention group (eye mask and earplugs) or a control group (standard nursing care).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şenay ARAS DOĞAN, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867523
- Sponsor's protocol ID
- 2023-14/15
- Other IDs
- THD-2025-1489
- Acronym
- PICU
- Status last verified
- Jan 2026
- First submitted
- 5 Mar 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hamza Ek, Aras Dogan S, Oto A. Short-term effects of eye masks and earplugs on delirium and pain in awake, spontaneously breathing pediatric intensive care patients: A randomized controlled trial. J Pediatr Nurs. 2026 May-Jun;88:117-126. doi: 10.1016/j.pedn.2026.02.015. Epub 2026 Feb 23.
PubMed 41734419
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eye Masks and Earplugs on Delirium and Pain Prevention in Pediatric Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT06867523
- Acronym / sponsor ID
- PICU / 2023-14/15
- Conditions
- Pain Management, Pediatric Intensive Care Unit, Non-Pharmacological Interventions, Critical Care Nursing, Pediatric Delirium
- Keywords
- Pediatric Intensive Care, Non-Pharmacological Interventions, Delirium Prevention, Pain Management, Critical Care Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled clinical trial aims to evaluate the effect of nighttime application of eye masks and earplugs on the incidence of delirium and pain levels in pediatric intensive care unit (PICU) patients aged 6-12 years.
Research Questions
This study seeks to answer the following key questions:
Do eye masks and earplugs reduce the incidence of delirium compared to standard nursing care in PICU patients? Do eye masks and earplugs lower pain levels compared to standard nursing care in PICU patients? Study Design
Participants will be randomly assigned to one of the following groups:
Intervention Group: Participants will wear an eye mask and earplugs from 11:00 PM to 07:00 AM for three consecutive nights.
Control Group: Participants will receive standard nursing care without any interventions.
Both groups will be assessed daily at 08:00 AM using the following standardized measures:
Cornell Pediatric Delirium Scale (to assess symptoms of confusion and disorientation) Validated faces-based pediatric pain scale via a secure telehealth platform (to measure pain levels) Glasgow Coma Scale (GCS) (to evaluate consciousness levels) Significance and Impact This study investigates the impact of reducing environmental stimuli (light and noise) on delirium incidence and pain levels in critically ill pediatric patients. The findings may contribute to the development of non-pharmacological interventions aimed at improving patient comfort and care in intensive care settings.
Data Analysis Statistical analyses will be performed using SPSS (version 27) to compare delirium incidence and pain levels between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to an intervention group (eye mask and earplugs) or a control group (standard nursing care).
| Arm | Type | Receives |
|---|---|---|
| Eye Mask & Earplugs | Experimental | Other: Eye Mask, Other: EarplugsParticipants in this group will use an eye mask and earplugs between 11:00 PM and 07:00 AM for three consecutive nights. The goal is to reduce environmental stimuli and evaluate the effects on delirium incidence and pain levels. |
| Standard Nursing Care | No intervention | –Participants in this group will receive standard nursing care without the use of an eye mask or earplugs. Their delirium incidence and pain levels will be assessed under usual care conditions. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Being between the ages of 6 and 12 years.
- Receiving treatment in the Pediatric Intensive Care Unit (PICU).
- Expected to stay in the intensive care unit for more than 24 hours.
- Having a Glasgow Coma Scale (GCS) score of 9 or above.
- Not receiving sedation.
Key exclusion criteria (7 listed)
- Children with diagnosed intellectual, auditory, or visual impairments.
- Children with a psychiatric diagnosis.
- Patients using hearing aids.
- Patients diagnosed with brain tumors.
- Patients requiring mechanical ventilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye MaskParticipants in this group will wear an eye mask between 11:00 PM and 07:00 AM for three consecutive nights to assess its effects on delirium and pain levels in pediatric intensive care unit patients | Other | Eye Mask & Earplugs |
| EarplugsParticipants in this group will use earplugs between 11:00 PM and 07:00 AM for three consecutive nights to evaluate their effects on delirium incidence and pain levels. | Other | Eye Mask & Earplugs |
Primary outcome
Incidence of Delirium in Pediatric ICU Patients
Time frame: 3 days after intervention
Delirium incidence will be assessed using the Cornell Pediatric Delirium Scale every morning at 08:00 AM for three consecutive days. The nurse rates each item of the screening questions on a scale from 0 (lowest) to 4 (highest). Scores ≥9 indicate delirium.
Pain Levels in Pediatric ICU Patients
Time frame: 3 days after intervention
Pain levels will be assessed every morning at 08:00 AM for three consecutive days using a validated faces-based pediatric pain assessment tool administered via a secure telehealth platform.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Derived from this study: PubMed 41734419Hamza Ek, Aras Dogan S, Oto A. Short-term effects of eye masks and earplugs on delirium and pain in awake, spontaneously breathing pediatric intensive care patients: A randomized controlled trial. J Pediatr Nurs. 2026 May-Jun;88:117-126. doi: 10.1016/j.pedn.2026.02.015. Epub 2026 Feb 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Mask and Earplugs in people with Pain Management and Pediatric Intensive Care Unit, run by Bozok University at 1 site in Turkey (Türkiye).
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 7 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: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Delirium in Pediatric ICU Patients (time frame: 3 days after intervention). The study lists 2 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 NCT06867523, which also lists 1 linked publication.
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 3 Feb 2026.