Eye Covering and White Noise During Nasogastric Tube Insertion in Preterm Infants
NCT07915154, Not applicable, Not yet recruiting, Marmara University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Eye Covering and White Noise During Nasogastric Tube Insertion in Preterm Infants | ClinicalTrials.gov |
| NCT number | NCT07915154 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Marmara University | ClinicalTrials.gov |
| Conditions | Preterm Infants | ClinicalTrials.gov |
| Interventions | Eye Covering, White Noise, Eye Covering and White Noise | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Neonatal Comfort Level Assessed Using the COMFORTneo Scale | 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion | The scale was developed to assess the behavior of 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. The lowest possible score on the Neonatal Comfort Behavior Scale is 6, and the highest is 30. Higher scores indicate that the infant is uncomfortable and requires interventions to ensure comfort. Additionally, on Numerical Rating Scales, scores between 4 and 6 indicate moderate pain and distress, while scores between 7 and 10 indicate severe pain and distress. The validity and reliability study of the scale in Turkish was conducted in 2014. In the Turkish validity and reliability study, the scale's Cronbach's alpha coefficient was reported as 0.85. | ClinicalTrials.gov |
| Secondary | Neonatal Pain and Stress Assessed Using the ALPS-Neo Scale | 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion | The scale was developed to assess pain and stress in preterm and term newborns, and its Cronbach's alpha coefficient has been reported as 0.95. The scale's validity and reliability in Turkish have been established. ALPS-Neo is a 3-point Likert-type scale consisting of five items: the newborn's facial expression, breathing pattern, limb tone, hand and foot movements, and activity level. Measurements are made through observation. As the score increases, the level of pain and stress increases. According to the assessment results, a score of 0-2 indicates the absence of pain and stress and that no intervention is required. A score of 3-5 indicates the presence of moderate pain and stress, while scores of 5 or higher indicate the presence of severe pain and stress. | ClinicalTrials.gov |
| Secondary | Heart Rate | 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. | ClinicalTrials.gov |
| Secondary | Respiratory Rate | 5 minutes before, during procedure, and 5 minutes after nasogastric tube insertion | Respiratory rate will be measured and recorded as breaths per minute. | ClinicalTrials.gov |
| Secondary | Oxygen Saturation | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)