Eye Covering and White Noise During Nasogastric Tube Insertion in Preterm Infants

November 3, 2026 updated by: Ayşegül Şimşek, Marmara University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Bağcılar Training and Research Hospital
        • Principal Investigator:
          • Aysegul Simsek, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • No sedation
  • No procedures such as peripheral intravenous catheter insertion, blood sampling, or aspiration within 1 hour before enrollment
  • Clinically stable condition

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eye Covering

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.
Other: Eye Covering

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.
Experimental: White Noise

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.
Other: White Noise

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.
Experimental: Eye Covering and White Noise

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.
Other: Eye Covering and White Noise

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Pain and Stress Assessed Using the ALPS-Neo Scale
Time Frame: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion

Neonatal pain and stress will be assessed using the ALPS-Neo Neonatal Pain and Stress Assessment Scale before, during, and after nasogastric tube insertion.
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

Heart rate will be measured using a pulse oximeter and recorded as beats per minute.
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

Respiratory rate will be measured and recorded as breaths per minute.
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

Peripheral oxygen saturation will be measured using a pulse oximeter and recorded as a percentage.
5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: Aysegul Simsek, PhD, Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

October 29, 2026

First Submitted That Met QC Criteria

November 3, 2026

First Posted (Actual)

November 4, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AS-NICU-NG-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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