PrematurityNCT07917871
Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm Infants
A study testing Massage, White Noise and Oral Motor Stimulation in people with Prematurity and Feeding Behaviors, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of short-term environmental comfort interventions and oral motor stimulation on comfort and oral feeding readiness in preterm infants. A total of 84 preterm infants who are clinically stable and transitioning to oral feeding will be assigned to one of four groups: massage, white… Read more about this study
- Who is it for?
- Ages 1 hour to 12 months
- Conditions the study is for
- Prematurity, Feeding Behaviors
- What is being tested?
- Massage, White Noise and Oral Motor Stimulation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Jan 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 1 hour to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born between 28 and 37 weeks of gestation
- Clinically stable preterm infants
- Infants for whom the physician has decided to initiate oral feeding
- Infants transitioning to oral feeding
- Written informed consent provided by a parent or legal guardian
Who cannot join
- Congenital anomalies or neurological disorders that may affect oral feeding
- Severe respiratory or cardiac problems that may prevent oral feeding
- Clinical instability that prevents participation in the study interventions or oral feeding
- Withdrawal of parental or legal guardian consent
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
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine Hospital
Istanbul
Dilara Karaköse, CN, +90 507 879 87 57, dilara.karakose1@iuc.edu.tr
About this study
Official title: Effects of Environmental Comfort and Oral Motor Stimulation Interventions on Comfort and Oral Feeding Readiness in Preterm Infants: An Experimental Study
This study aims to evaluate the effects of short-term environmental comfort interventions and oral motor stimulation on comfort and oral feeding readiness in preterm infants. A total of 84 preterm infants who are clinically stable and transitioning to oral feeding will be assigned to one of four groups: massage, white noise, oral stimulation, or routine care (control). Before the intervention, infant comfort and oral feeding readiness will be assessed using the Premature Infant Comfort Scale and the Preterm Oral Feeding Readiness Assessment Scale (POFRAS). Infants in the intervention groups will receive a single 5-minute session of massage, white noise, or oral stimulation before their first oral feeding, while infants in the control group will receive routine care. Comfort and oral feeding readiness will be assessed during the study to compare the effects of the interventions. The study will also examine the relationship between comfort and oral feeding readiness in preterm infants.
Read the detailed description
This experimental study will be conducted with preterm infants receiving care in the Neonatal Intensive Care Unit of Cerrahpaşa Faculty of Medicine Hospital. The study will include 84 preterm infants born between 28 and 37 weeks of gestation who are clinically stable and in the process of transitioning to oral feeding. Eligible infants will be randomly assigned to one of four study groups: massage, white noise, oral stimulation, or routine care (control). Before the assigned intervention, descriptive and clinical information will be recorded, and the infants will be assessed using the Premature Infant Comfort Scale and the Preterm Oral Feeding Readiness Assessment Scale (POFRAS). In the massage group, infants will receive a 5-minute session consisting of gentle and rhythmic tactile stimulation. In the white noise group, white noise at an intensity of 40-60 dB will be provided for 5 minutes. In the oral stimulation group, infants will receive a 5-minute oral motor stimulation intervention involving gentle stimulation of the lips, cheeks, palate, gums, and tongue, with non-nutritive sucking when appropriate. Infants assigned to the control group will receive routine neonatal care without an additional study intervention. The assigned intervention will be administered once before the infant's first oral feeding. Following the intervention period, the infant's comfort and oral feeding readiness will be evaluated according to the study assessment schedule, and the first oral feeding will be performed when oral feeding has been clinically authorized by the physician. The study will compare comfort and oral feeding readiness among the intervention and control groups and will examine the relationship between comfort and oral feeding readiness in preterm infants.
- Conditions
- Prematurity, Feeding Behaviors
- Being tested
- Massage, White Noise, Oral Motor Stimulation, Routine Care
- Keywords
- Preterm infant, Oral feeding readiness, Infant comfort, Oral motor stimulation, Massage, White noise, Neonatal Intensive Cre Unit
- Medical subject headings
- Premature Birth, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageBehavioural
A single 5-minute massage session will be administered before the infant's first oral feeding. The intervention will include gentle rhythmic stroking of the back and shoulders, gentle downward stroking of the back, slow rhythmic touch to the shoulder or head area, and gentle hand contact over the abdominal area.
White NoiseBehavioural
White noise at an intensity of 40-60 dB will be provided for 5 minutes before the infant's first oral feeding. The sound source will be positioned approximately 30-50 cm from the infant's bed. No additional care or procedure will be performed during the intervention.
Oral Motor StimulationBehavioural
A single 5-minute oral motor stimulation session will be administered before the infant's first oral feeding. The intervention will include gentle stimulation of the lips, inner cheeks, palate, gums, and tongue. Non-nutritive sucking using a sterile finger or pacifier may be provided when appropriate.
Routine CareOther
Infants assigned to the control group will receive routine neonatal care without additional massage, white noise, or oral motor stimulation as part of the study intervention.
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | Infants assigned to this group will receive a single 5-minute massage intervention before their first oral feeding. The intervention will include gentle, rhythmic tactile stimulation of the back and shoulders, followed by gentle stroking and touch. Receives: Behavioral: Massage |
| White Noise | Experimental | Infants assigned to this group will be exposed to white noise at an intensity of 40-60 dB for 5 minutes before their first oral feeding. No additional care or procedure will be performed during the white noise intervention. Receives: Behavioral: White Noise |
| Oral Stimulation | Experimental | Infants assigned to this group will receive a single 5-minute oral motor stimulation intervention before their first oral feeding. The intervention will include gentle stimulation of the lips, inner cheeks, palate, gums, and tongue, with non-nutritive sucking when appropriate. Receives: Behavioral: Oral Motor Stimulation |
| Routine Care | Active comparator | Infants assigned to the control group will receive routine neonatal care without an additional study intervention before their first oral feeding. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Premature Infant Comfort Scale Score
Developed by Monique and her colleagues, this is an observation-based scale used to assess the comfort level of premature infants. The scale was adapted into Turkish by Dilek Küçük Alemdar and Fatma Güdücü Tüfekçi (2015) in Turkey, and a validity and reliability study was conducted. The scale consists of a total of 7 items: level of alertness, agitation, crying, physical movement, muscle tone, facial expressions, and heart rate. Each item is rated on a scale of 1 to 5, and the total score ranges from 7 to 35. There are no reverse-scored items on the scale. Factor analysis conducted as part of the construct validity assessment determined that the scale exhibits a unifactorial structure, explaining 57.7% of the total variance. The scale's Cronbach's alpha reliability coefficient was reported as 0.88.
Measured: Within 1 minute before the start of the intervention, within 1 minute after the completion of the 5-minute intervention (before the first oral feeding), and within 1 minute after the completion of the first oral feeding.
Change in Preterm Oral Feeding Readiness Assessment Scale Score
Developed by Cristina Ide Fujinaga and colleagues (2007) to assess how ready preterm infants are for the transition to oral feeding, the scale underwent a clinical validity study in 2013. The Turkish validity and reliability study of the scale was conducted by Çamur and Çetinkaya (2021). The scale consists of a total of 18 items, each of which is scored on a scale of 0, 1, or 2. The total possible score ranges from 0 to 36. There are no reverse-scored items on the scale. The scale covers areas such as behavioral status, oral-motor posture, reflexes, and sucking behavior; while its subdimensions are not explicitly named, they are clinically grouped under five headings: corrected gestational age, behavioral organization, oral posture, reflex assessment, and non-nutritive sucking. In the Turkish adaptation, the optimal cutoff score for the scale was reported as 29, and the Cronbach's alpha internal consistency coefficient was found to be 0.87.
Measured: Within 1 minute before the start of the intervention (initial assessment) and within 1 minute after the completion of the 5-minute intervention (before the start of the first oral feeding).
Secondary outcomes (1)
Time to Initiate Post-intervention Oral Feeding
The time to initiation of the first oral feeding in preterm infants will be defined as the duration from the completion of the 5-minute intervention until the start of the first oral feeding. This duration will be recorded in minutes and compared across groups. The first oral feeding will be administered to infants determined by a physician to be ready for oral feeding.
Measured: The time elapsed (in minutes) from the completion of the five-minute intervention until the start of the first oral feeding up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible preterm infants will be randomly assigned to one of four parallel groups: massage, white noise, oral stimulation, or routine care (control). Each participant will receive only the intervention assigned to their study group.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aysegul Simsek, PhD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917871
- Sponsor's protocol ID
- MU-SBF-2025-173
- Status last verified
- Nov 2026
- First submitted
- 29 Oct 2026
- Last updated
- 5 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Environmental Comfort and Oral Motor Stimulation Interventions on Comfort and Oral Feeding Readiness in Preterm Infants: An Experimental Study
- ClinicalTrials.gov ID
- NCT07917871
- Acronym / sponsor ID
- MU-SBF-2025-173
- Conditions
- Prematurity, Feeding Behaviors
- Keywords
- Preterm infant, Oral feeding readiness, Infant comfort, Oral motor stimulation, Massage, White noise, Neonatal Intensive Cre Unit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 5 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 short-term environmental comfort interventions and oral motor stimulation on comfort and oral feeding readiness in preterm infants. A total of 84 preterm infants who are clinically stable and transitioning to oral feeding will be assigned to one of four groups: massage, white noise, oral stimulation, or routine care (control). Before the intervention, infant comfort and oral feeding readiness will be assessed using the Premature Infant Comfort Scale and the Preterm Oral Feeding Readiness Assessment Scale (POFRAS). Infants in the intervention groups will receive a single 5-minute session of massage, white noise, or oral stimulation before their first oral feeding, while infants in the control group will receive routine care. Comfort and oral feeding readiness will be assessed during the study to compare the effects of the interventions. The study will also examine the relationship between comfort and oral feeding readiness in preterm infants.
Detailed description
This experimental study will be conducted with preterm infants receiving care in the Neonatal Intensive Care Unit of Cerrahpaşa Faculty of Medicine Hospital. The study will include 84 preterm infants born between 28 and 37 weeks of gestation who are clinically stable and in the process of transitioning to oral feeding. Eligible infants will be randomly assigned to one of four study groups: massage, white noise, oral stimulation, or routine care (control). Before the assigned intervention, descriptive and clinical information will be recorded, and the infants will be assessed using the Premature Infant Comfort Scale and the Preterm Oral Feeding Readiness Assessment Scale (POFRAS). In the massage group, infants will receive a 5-minute session consisting of gentle and rhythmic tactile stimulation. In the white noise group, white noise at an intensity of 40-60 dB will be provided for 5 minutes. In the oral stimulation group, infants will receive a 5-minute oral motor stimulation intervention involving gentle stimulation of the lips, cheeks, palate, gums, and tongue, with non-nutritive sucking when appropriate. Infants assigned to the control group will receive routine neonatal care without an additional study intervention. The assigned intervention will be administered once before the infant's first oral feeding. Following the intervention period, the infant's comfort and oral feeding readiness will be evaluated according to the study assessment schedule, and the first oral feeding will be performed when oral feeding has been clinically authorized by the physician. The study will compare comfort and oral feeding readiness among the intervention and control groups and will examine the relationship between comfort and oral feeding readiness in preterm infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Eligible preterm infants will be randomly assigned to one of four parallel groups: massage, white noise, oral stimulation, or routine care (control). Each participant will receive only the intervention assigned to their study group.
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Behavioral: MassageInfants assigned to this group will receive a single 5-minute massage intervention before their first oral feeding. The intervention will include gentle, rhythmic tactile stimulation of the back and shoulders, followed by gentle stroking and touch. |
| White Noise | Experimental | Behavioral: White NoiseInfants assigned to this group will be exposed to white noise at an intensity of 40-60 dB for 5 minutes before their first oral feeding. No additional care or procedure will be performed during the white noise intervention. |
| Oral Stimulation | Experimental | Behavioral: Oral Motor StimulationInfants assigned to this group will receive a single 5-minute oral motor stimulation intervention before their first oral feeding. The intervention will include gentle stimulation of the lips, inner cheeks, palate, gums, and tongue, with non-nutritive sucking when appropriate. |
| Routine Care | Active comparator | Other: Routine CareInfants assigned to the control group will receive routine neonatal care without an additional study intervention before their first oral feeding. |
Who may qualify
- Ages
- 1 hour to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm infants born between 28 and 37 weeks of gestation
- Clinically stable preterm infants
- Infants for whom the physician has decided to initiate oral feeding
- Infants transitioning to oral feeding
- Written informed consent provided by a parent or legal guardian
Key exclusion criteria (4 listed)
- Congenital anomalies or neurological disorders that may affect oral feeding
- Severe respiratory or cardiac problems that may prevent oral feeding
- Clinical instability that prevents participation in the study interventions or oral feeding
- Withdrawal of parental or legal guardian consent
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 |
|---|---|---|
| MassageA single 5-minute massage session will be administered before the infant's first oral feeding. The intervention will include gentle rhythmic stroking of the back and shoulders, gentle downward stroking of the back, slow rhythmic touch to the shoulder or head area, and gentle hand contact over the abdominal area. | Behavioural | Massage |
| White NoiseWhite noise at an intensity of 40-60 dB will be provided for 5 minutes before the infant's first oral feeding. The sound source will be positioned approximately 30-50 cm from the infant's bed. No additional care or procedure will be performed during the intervention. | Behavioural | White Noise |
| Oral Motor StimulationA single 5-minute oral motor stimulation session will be administered before the infant's first oral feeding. The intervention will include gentle stimulation of the lips, inner cheeks, palate, gums, and tongue. Non-nutritive sucking using a sterile finger or pacifier may be provided when appropriate. | Behavioural | Oral Stimulation |
| Routine CareInfants assigned to the control group will receive routine neonatal care without additional massage, white noise, or oral motor stimulation as part of the study intervention. | Other | Routine Care |
Primary outcome
Change in Premature Infant Comfort Scale Score
Time frame: Within 1 minute before the start of the intervention, within 1 minute after the completion of the 5-minute intervention (before the first oral feeding), and within 1 minute after the completion of the first oral feeding.
Developed by Monique and her colleagues, this is an observation-based scale used to assess the comfort level of premature infants. The scale was adapted into Turkish by Dilek Küçük Alemdar and Fatma Güdücü Tüfekçi (2015) in Turkey, and a validity and reliability study was conducted. The scale consists of a total of 7 items: level of alertness, agitation, crying, physical movement, muscle tone, facial expressions, and heart rate. Each item is rated on a scale of 1 to 5, and the total score ranges from 7 to 35. There are no reverse-scored items on the scale. Factor analysis conducted as part of the construct validity assessment determined that the scale exhibits a unifactorial structure, explaining 57.7% of the total variance. The scale's Cronbach's alpha reliability coefficient was reported as 0.88.
Change in Preterm Oral Feeding Readiness Assessment Scale Score
Time frame: Within 1 minute before the start of the intervention (initial assessment) and within 1 minute after the completion of the 5-minute intervention (before the start of the first oral feeding).
Developed by Cristina Ide Fujinaga and colleagues (2007) to assess how ready preterm infants are for the transition to oral feeding, the scale underwent a clinical validity study in 2013. The Turkish validity and reliability study of the scale was conducted by Çamur and Çetinkaya (2021). The scale consists of a total of 18 items, each of which is scored on a scale of 0, 1, or 2. The total possible score ranges from 0 to 36. There are no reverse-scored items on the scale. The scale covers areas such as behavioral status, oral-motor posture, reflexes, and sucking behavior; while its subdimensions are not explicitly named, they are clinically grouped under five headings: corrected gestational age, behavioral organization, oral posture, reflex assessment, and non-nutritive sucking. In the Turkish adaptation, the optimal cutoff score for the scale was reported as 29, and the Cronbach's alpha internal consistency coefficient was found to be 0.87.
1 secondary outcome
Time to Initiate Post-intervention Oral Feeding
Time frame: The time elapsed (in minutes) from the completion of the five-minute intervention until the start of the first oral feeding up to 20 minutes
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 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
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 Massage, White Noise and Oral Motor Stimulation in people with Prematurity and Feeding Behaviors, 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 5 inclusion and 4 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 5 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 Aysegul 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?
Change in Premature Infant Comfort Scale Score (time frame: Within 1 minute before the start of the intervention, within 1 minute after the completion of the 5-minute intervention (before the first oral feeding), and within 1 minute after the completion of the first oral feeding.). 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?
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 5 Nov 2026.