An interventional study of Eye Covering and White Noise in Preterm Infants, sponsored by Marmara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 3 Days and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Marmara University · Not applicable, Interventional, and Other
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.
Preterm infants are more sensitive to invasive procedures and environmental stimuli performed in neonatal intensive care units because their physiological and neurological systems are not yet fully mature. Nasogastric tube placement is one of the procedures frequently performed on these infants and can cause pain, stress, behavioral distress, and changes in physiological parameters. Therefore, it is important to evaluate non-pharmacological developmental care interventions aimed at reducing pain and stress, increasing comfort, and supporting physiological stability during the procedure. Eye-covering is a non-pharmacological intervention designed to reduce environmental light stimuli. White noise, on the other hand, aims to support the infant's calming and reduce sensitivity to environmental sounds by providing a continuous auditory stimulus without sudden changes. However, evidence regarding the effects of applying these two interventions-separately or in combination-during nasogastric tube placement on preterm infants' comfort, pain, stress levels, and physiological parameters is limited.
This study is a single-center, three-arm, randomized controlled trial planned to be conducted in the neonatal intensive care unit of a university hospital. A total of 90 preterm infants are planned to be included in the study, and the infants will be randomly assigned to three groups in a 1:1:1 ratio. Randomization will be performed using an online randomization program.
Infants in the first group will be fitted with a phototherapy eye mask 15 minutes before nasogastric tube placement, and the eye mask will be kept in place during the procedure and for 15 minutes afterward. Infants in the second group will begin listening to white noise 15 minutes before nasogastric tube placement, and the white noise will continue during the procedure and for 15 minutes afterward. White noise will be administered at a sound level of 40-60 dB via a pre-recorded audio file, and the sound source will be positioned approximately 30-50 cm away from the infant. For infants in the third group, both the eye-covering and white noise interventions will be administered simultaneously. Both interventions will begin 15 minutes before nasogastric tube placement and will continue throughout the procedure and for 15 minutes afterward. In all groups, the infants' comfort, pain, and stress levels, as well as their physiological parameters, will be assessed at three different time points: 5 minutes before the procedure, during the procedure, and 5 minutes after the procedure. Comfort levels will be determined using the Neonatal Comfort Behavior Scale (COMFORTneo), while pain and stress levels will be assessed using the ALPS-NEO Neonatal Pain and Stress Assessment Scale. Physiological assessments will include measurements of heart rate, respiratory rate, and oxygen saturation.
Nasogastric tube placement will be performed by healthcare professionals working in the neonatal intensive care unit in accordance with the infant's clinical needs. No additional invasive procedures beyond clinical care requirements will be performed on the infants as part of this study. To minimize assessment bias, comfort, pain, and stress assessments will be conducted by neonatal nurses who are not part of the research team; physiological parameters will be recorded by the researcher. The study aims to compare the effects of eye-covering and white noise-both individually and in combination-on preterm infants' comfort, pain, stress levels, and physiological responses. The findings are expected to contribute to the scientific evidence regarding non-pharmacological, developmentally-based nursing interventions that can be used during nasogastric tube placement in neonatal intensive care units.
Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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Exclusion Criteria:
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
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
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 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 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 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.
Neonatal Comfort Level Assessed Using the COMFORTneo Scale
The scale was developed to measure behavior in newborns in the intensive care unit without relying on physiological parameters. COMFORTneo is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. It is stated that the lowest possible score on the Neonatal Comfort Behavior Scale is 6, and the highest is 30. High scores indicate that the infant is not comfortable and requires interventions to ensure comfort. Additionally, scores of 4-6 on the Numerical Rating Scales indicate moderate pain and distress, while scores of 7-10 indicate severe pain and distress. The Turkish validity and reliability study of the scale was conducted by Kahraman et al. in 2014. In the Turkish validity and reliability study, the Cronbach's alpha coefficient for the scale was reported as 0.85.
Time frame: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
Neonatal Pain and Stress Assessed Using the ALPS-Neo Scale
It was developed by Lundqvist et al. to assess pain and stress in preterm and term newborns, and the scale's Cronbach's alpha coefficient was reported as 0.95 (Lundqvist et al. 2014). The Turkish validity and reliability of the scale were established by Ceylan and Bolışık (2017). The ALPS-Neo is a 3-point Likert-type scale consisting of 5 items: the newborn's facial expression, breathing pattern, limb tone, hand and foot activities, and activity level. Measurements are made through observation. As the score increases, pain and stress increase. The evaluation results indicate that a score of 0-2 indicates the presence of pain and stress; no intervention is required for pain and stress. A score of 3-5 indicates the presence of moderate pain and stress. A score of 5 or higher indicates the presence of severe pain and stress.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion
Plan to share: No
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Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
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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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