Preterm InfantsNCT07915154
Eye Covering and White Noise During Nasogastric Tube Insertion in Preterm Infants
A study testing Eye Covering, White Noise and Eye Covering and White Noise in people with Preterm Infants, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of eye covering and white noise during nasogastric tube insertion on comfort, pain, stress, and physiological parameters in preterm infants. Read more about this study
- Who is it for?
- Ages 3 days and older
- Conditions the study is for
- Preterm Infants
- What is being tested?
- Eye Covering, White Noise and Eye Covering and White Noise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Nov 2027
- 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 3 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written and verbal parental consent for participation
- Gestational age between 32 and 36 weeks
- Birth weight of 1500 g or greater
- Apgar score of 6 or greater at 1 and 5 minutes
- Postnatal age of 3 days or older
- Hospitalization in the neonatal intensive care unit for more than 24 hours
Show all 9Show fewer
- No sedation
- No procedures such as peripheral intravenous catheter insertion, blood sampling, or aspiration within 1 hour before enrollment
- Clinically stable condition
Who cannot join
- Central nervous system problems such as intracranial hemorrhage, seizures, or hypertonia
- Congenital or genetic anomalies
- Receiving phototherapy
- Respiratory distress requiring oxygen support
- Receiving mechanical ventilation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bağcılar Training and Research Hospital
Istanbul
Aysegul Simsek, PhD, +905413155774, asimsek@marmara.edu.tr
Aysegul Simsek, PhD
About this study
Official title: The Effect of Eye Covering and White Noise During Nasogastric Tube Insertion on Comfort, Pain, Stress, and Physiological Parameters in Preterm Infants
This study aims to evaluate the effects of eye covering and white noise during nasogastric tube insertion on comfort, pain, stress, and physiological parameters in preterm infants. A total of 90 preterm infants will be randomly assigned to one of three groups: eye covering, white noise, or combined eye covering and white noise. Comfort, pain, stress, heart rate, respiratory rate, and oxygen saturation will be assessed before, during, and after nasogastric tube insertion.
- Conditions
- Preterm Infants
- Being tested
- Eye Covering, White Noise, Eye Covering and White Noise
- Keywords
- Nasogastric Tube Insertion, Eye Covering, White Noise, Neonatal Comfort, Neonatal Pain, Neonatal Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye CoveringOther
Eye covering will be applied 15 minutes before nasogastric tube insertion and will remain in place during the procedure and for 15 minutes after the procedure.
White NoiseOther
White noise at 45 dB will be started 15 minutes before nasogastric tube insertion and will continue during the procedure and for 15 minutes after the procedure.
Eye Covering and White NoiseOther
Eye covering and white noise at 45 dB will be applied together beginning 15 minutes before nasogastric tube insertion. Both interventions will continue during the procedure and for 15 minutes after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Eye Covering | Experimental | Preterm infants will receive eye covering beginning 15 minutes before nasogastric tube insertion. The eye covering will remain in place during the procedure and for 15 minutes after the procedure. Receives: Other: Eye Covering |
| White Noise | Experimental | Preterm infants will receive white noise at 45 dB beginning 15 minutes before nasogastric tube insertion. White noise will continue during the procedure and for 15 minutes after the procedure. Receives: Other: White Noise |
| Eye Covering and White Noise | Experimental | Preterm infants will receive both eye covering and white noise beginning 15 minutes before nasogastric tube insertion. Both interventions will continue during the procedure and for 15 minutes after the procedure. Receives: Other: Eye Covering and White Noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Comfort Level Assessed Using the COMFORTneo Scale
Neonatal comfort will be assessed using the COMFORTneo Scale before, during, and after nasogastric tube insertion. COMFORTneo is used to assess comfort and distress in neonates.
Measured: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
Secondary outcomes (4)
Neonatal Pain and Stress Assessed Using the ALPS-Neo Scale
Neonatal pain and stress will be assessed using the ALPS-Neo Neonatal Pain and Stress Assessment Scale before, during, and after nasogastric tube insertion.
Measured: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
Heart Rate
Heart rate will be measured using a pulse oximeter and recorded as beats per minute.
Measured: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
Respiratory Rate
Respiratory rate will be measured and recorded as breaths per minute.
Measured: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
Oxygen Saturation
Peripheral oxygen saturation will be measured using a pulse oximeter and recorded as a percentage.
Measured: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Şimşek, Marmara University
- Investigators
- Aysegul Simsek, PhD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915154
- Sponsor's protocol ID
- AS-NICU-NG-2026-01
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eye Covering and White Noise During Nasogastric Tube Insertion on Comfort, Pain, Stress, and Physiological Parameters in Preterm Infants
- ClinicalTrials.gov ID
- NCT07915154
- Acronym / sponsor ID
- AS-NICU-NG-2026-01
- Conditions
- Preterm Infants
- Keywords
- Nasogastric Tube Insertion, Eye Covering, White Noise, Neonatal Comfort, Neonatal Pain, Neonatal Stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 4 Nov 2026 (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 study aims to evaluate the effects of eye covering and white noise during nasogastric tube insertion on comfort, pain, stress, and physiological parameters in preterm infants. A total of 90 preterm infants will be randomly assigned to one of three groups: eye covering, white noise, or combined eye covering and white noise. Comfort, pain, stress, heart rate, respiratory rate, and oxygen saturation will be assessed before, during, and after nasogastric tube insertion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eye Covering | Experimental | Other: Eye CoveringPreterm infants will receive eye covering beginning 15 minutes before nasogastric tube insertion. The eye covering will remain in place during the procedure and for 15 minutes after the procedure. |
| White Noise | Experimental | Other: White NoisePreterm infants will receive white noise at 45 dB beginning 15 minutes before nasogastric tube insertion. White noise will continue during the procedure and for 15 minutes after the procedure. |
| Eye Covering and White Noise | Experimental | Other: Eye Covering and White NoisePreterm infants will receive both eye covering and white noise beginning 15 minutes before nasogastric tube insertion. Both interventions will continue during the procedure and for 15 minutes after the procedure. |
Who may qualify
- Ages
- 3 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Written and verbal parental consent for participation
- Gestational age between 32 and 36 weeks
- Birth weight of 1500 g or greater
- Apgar score of 6 or greater at 1 and 5 minutes
- Postnatal age of 3 days or older
Key exclusion criteria (5 listed)
- Central nervous system problems such as intracranial hemorrhage, seizures, or hypertonia
- Congenital or genetic anomalies
- Receiving phototherapy
- Respiratory distress requiring oxygen support
- Receiving 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 CoveringEye covering will be applied 15 minutes before nasogastric tube insertion and will remain in place during the procedure and for 15 minutes after the procedure. | Other | Eye Covering |
| White NoiseWhite noise at 45 dB will be started 15 minutes before nasogastric tube insertion and will continue during the procedure and for 15 minutes after the procedure. | Other | White Noise |
| Eye Covering and White NoiseEye covering and white noise at 45 dB will be applied together beginning 15 minutes before nasogastric tube insertion. Both interventions will continue during the procedure and for 15 minutes after the procedure. | Other | Eye Covering and White Noise |
Primary outcome
Neonatal Comfort Level Assessed Using the COMFORTneo Scale
Time frame: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
Neonatal comfort will be assessed using the COMFORTneo Scale before, during, and after nasogastric tube insertion. COMFORTneo is used to assess comfort and distress in neonates.
4 secondary outcomes
Neonatal Pain and Stress Assessed Using the ALPS-Neo Scale
Time frame: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
Heart Rate
Time frame: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
Respiratory Rate
Time frame: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
Oxygen Saturation
Time frame: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Preterm Infants
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Aysegul Simsek, PhD principal investigator
Marmara University
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 Covering, White Noise and Eye Covering and White Noise in people with Preterm Infants, run by Marmara 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 9 inclusion and 5 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 4 Nov 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?
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 Aysegu Simsek, PhD (+905413155774, asimsek@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Comfort Level Assessed Using the COMFORTneo Scale (time frame: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.