Neonatal Intensive Care UnitMSINCT07725094
Maternal Sensory Interventions in Newborns
A study testing Kangaroo Care, Maternal Lullaby and Maternal Tactile-Auditory Soothing in people with Neonatal Intensive Care Unit and Hospitalized Newborn, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to determine the effects of maternal sensory interventions (kangaroo care, lullabies, and maternal tactile-auditory soothing) on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the neonatal intensive care unit. Read more about this study
- Who is it for?
- Ages 35 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal Intensive Care Unit, Hospitalized Newborn
- What is being tested?
- Kangaroo Care, Maternal Lullaby and Maternal Tactile-Auditory Soothing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2026to 30 Dec 2026
- 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 35 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age between 35 and 42 completed weeks.
- Birth weight between 2,000 and 4,200 grams.
- Clinically stable newborn admitted to the neonatal intensive care unit.
- Spontaneous breathing without the need for mechanical ventilation.
- Not receiving sedative medications.
- Written informed consent obtained from a parent or legal guardian.
Who cannot join
- Five-minute Apgar score <4.
- Requirement for advanced resuscitation after birth.
- Presence of a major congenital anomaly.
- Requirement for invasive intervention involving the head region.
- Diagnosed central nervous system dysfunction or neurological disorder.
- Presence of severe postnatal medical complications that may affect study outcomes.
- The newborn develops an unexpected need for resuscitation during the study, as this may adversely affect the central nervous system and consequently influence sleep-wake patterns and study outcomes.
- A parent or legal guardian withdraws consent for the newborn's participation in the study.
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
Kirsehir Ahi Evran Universty
Kırşehir, Kırşehir, 40100
Edanur Tar Bolacalı, PhD, +908504412483, edanurtar.1107@gmail.com
About this study
Official title: The Effect of Maternal Sensory Stimulation (Kangaroo Care, Lullabies, Tactile-Auditory Soothing) on Newborns' Sleep-Wake State and Physiological Parameters: A Randomized Controlled Trial
This study was designed to determine the effects of maternal sensory interventions (kangaroo care, lullabies, and maternal tactile-auditory soothing) on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the neonatal intensive care unit.
Read the detailed description
Sleep organization and physiological stability are essential indicators of neurological development and overall health in newborns. However, newborns hospitalized in neonatal intensive care units (NICUs) are frequently exposed to environmental stressors, including excessive noise, continuous lighting, routine caregiving activities, and medical procedures, which may adversely affect sleep quality and physiological stability. Maternal sensory interventions are non-pharmacological developmental care approaches that may promote relaxation, improve sleep organization, and support physiological regulation through tactile and auditory stimulation. This study is designed as a single-center, four-arm, parallel-group randomized controlled trial to evaluate the effects of maternal sensory interventions on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the NICU. Eligible clinically stable newborns will be randomly assigned in a 1:1:1:1 ratio to one of four groups: kangaroo care, maternal lullaby, maternal tactile-auditory soothing, or routine care (control). Following routine midday care and feeding, newborns in the kangaroo care group will receive uninterrupted skin-to-skin contact with their mothers for 60 minutes. In the maternal lullaby group, mothers will sing a lullaby of their choice for 15 minutes. In the maternal tactile-auditory soothing group, mothers will gently provide rhythmic tactile stimulation to the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds ("pış pış") for 15 minutes. Infants in the control group will receive routine NICU care without additional intervention. All newborns will be monitored for a total of 60 minutes following the intervention or routine care. Sleep-wake states will be continuously assessed using the Bispectral Index (BIS) monitor. Physiological parameters, including heart rate, respiratory rate, and oxygen saturation, will be recorded at predetermined time points using standard patient monitoring equipment. Sleep onset latency, as well as the duration of wakefulness, REM sleep, light sleep, and deep sleep, will be calculated from BIS recordings. The findings of this study are expected to provide evidence regarding the effectiveness of maternal sensory interventions in improving sleep organization and physiological stability in newborns and to contribute to the development of evidence-based developmental care practices in neonatal intensive care units.
- Conditions
- Neonatal Intensive Care Unit, Hospitalized Newborn
- Being tested
- Kangaroo Care, Maternal Lullaby, Maternal Tactile-Auditory Soothing
- Keywords
- Bispectral Index, Kangaroo Care, Lullaby, Maternal Sensory Intervention, Newborn, Neonatal Intensive Care Unit, Physiological Parameters, Randomized Controlled Trial, Sleep-Wake States
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo CareBehavioural
Kangaroo care will be provided by the mother for 60 minutes following routine midday care and feeding. The newborn, wearing only a diaper, will be placed in an upright skin-to-skin position on the mother's bare chest. The infant's head will be positioned to maintain airway patency, and a light blanket will be used to maintain thermal stability. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored throughout the 60-minute observation period.
Maternal LullabyBehavioural
Following routine midday care and feeding, mothers will sing a lullaby of their choice to their newborn for 15 minutes while the infant remains in the crib. The lullaby will be performed in a soft, soothing voice at a sound level not exceeding 45-50 dB. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.
Maternal Tactile-Auditory SoothingBehavioural
Following routine midday care and feeding, mothers will provide gentle rhythmic tactile stimulation by softly stroking the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds ("pış pış") for 15 minutes. The sound level will not exceed 45-50 dB. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group 1: Kangaroo Care | Experimental | Participants assigned to this group will receive kangaroo care provided by their mothers for 60 minutes following routine midday care and feeding. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes. Receives: Behavioral: Kangaroo Care |
| Intervention Group 2: Maternal Lullaby | Experimental | Participants assigned to this group will receive maternal lullaby intervention for 15 minutes following routine midday care and feeding. Mothers will sing a lullaby of their choice while the infant remains in the crib. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes. Receives: Behavioral: Maternal Lullaby |
| Intervention Group 3: Maternal Tactile-Auditory Soothing | Experimental | Participants assigned to this group will receive maternal tactile-auditory soothing for 15 minutes following routine midday care and feeding. Mothers will provide gentle rhythmic tactile stimulation to the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds ("pış pış"). Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes. Receives: Behavioral: Maternal Tactile-Auditory Soothing |
| Routine Care (Control) | No intervention | Participants assigned to this group will receive routine neonatal intensive care without any additional sensory intervention. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes following routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep-Wake States Assessed by Bispectral Index
Sleep-wake states will be assessed continuously using the Bispectral Index (BIS), a processed electroencephalographic monitoring system with scores ranging from 0 to 100, where higher scores indicate greater wakefulness and lower scores indicate deeper levels of sleep. BIS values will be classified as wakefulness (91-100), REM sleep (80-90), light sleep (55-79), and deep sleep (0-54). The duration and percentage of time spent in each sleep-wake state will be calculated during the 60-minute observation period.
Measured: During the 60-minute observation period following routine midday care and feeding
Sleep Onset Latency
Sleep onset latency will be defined as the time, in minutes, from the beginning of the assigned intervention or routine care until the BIS value first decreases below 91, indicating transition from wakefulness to sleep.
Measured: From the beginning of the intervention until sleep onset, assessed within 60 minutes
Mean Bispectral Index Score
The mean Bispectral Index (BIS) score will be calculated from values recorded at one-minute intervals throughout the 60-minute monitoring period. BIS scores range from 0 to 100, with higher scores indicating greater wakefulness and lower scores indicating deeper sleep.
Measured: During the 60-minute observation period
Secondary outcomes (3)
Heart Rate
Heart rate (beats per minute) will be recorded using the standard patient monitor at baseline (0 minutes) and at 15, 30, and 60 minutes during the observation period.
Measured: Baseline, 15, 30, and 60 minutes after the intervention or routine care
Respiratory Rate
Respiratory rate (breaths per minute) will be recorded using the standard patient monitor at baseline (0 minutes) and at 15, 30, and 60 minutes during the observation period.
Measured: Baseline, 15, 30, and 60 minutes after the intervention or routine care
Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (SpO₂, %) will be measured using the standard patient monitor at baseline (0 minutes) and at 15, 30, and 60 minutes during the observation period.
Measured: Baseline, 15, 30, and 60 minutes after the intervention or routine care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal Intensive Care UnitStudies of the same condition, open and under way.
- 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
- Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel groups: Kangaroo Care, Maternal Lullaby, Maternal Tactile-Auditory Soothing, or Routine Care. Each participant will receive only the intervention assigned to their group, and outcomes will be compared between groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edanur Tar Bolacali, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725094
- Sponsor's protocol ID
- KAEU-NICU-2026-01
- Acronym
- MSI
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yasova Barbeau D, Krueger C, Huene M, Copenhaver N, Bennett J, Weaver M, Weiss MD. Heart rate variability and inflammatory markers in neonates with hypoxic-ischemic encephalopathy. Physiol Rep. 2019 Aug;7(15):e14110. doi: 10.14814/phy2.14110.
PubMed 31397094intensive care unit. Medicine, 100(43), e27587. https://doi.org/10.1097/md.0000000000027587 Kahraman, A., Başbakkal, Z., & Yalaz, M. (2014). Turkish validity and reliability of the Newborn Comfort Behavior Scale. International Refereed Journal of Nursing Research, 1(2), 1-11.
Huang Q, Lai X, Liao J, Tan Y. Effect of non-pharmacological interventions on sleep in preterm infants in the neonatal intensive care unit: A protocol for systematic review and network meta-analysis. Medicine (Baltimore). 2021 Oct 29;100(43):e27587. doi: 10.1097/MD.0000000000027587.
PubMed 34713833Caba-Flores MD, Ramos-Ligonio A, Camacho-Morales A, Martinez-Valenzuela C, Viveros-Contreras R, Caba M. Breast Milk and the Importance of Chrononutrition. Front Nutr. 2022 May 12;9:867507. doi: 10.3389/fnut.2022.867507. eCollection 2022.
PubMed 35634367
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Maternal Sensory Stimulation (Kangaroo Care, Lullabies, Tactile-Auditory Soothing) on Newborns' Sleep-Wake State and Physiological Parameters: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07725094
- Acronym / sponsor ID
- MSI / KAEU-NICU-2026-01
- Conditions
- Neonatal Intensive Care Unit, Hospitalized Newborn
- Keywords
- Bispectral Index, Kangaroo Care, Lullaby, Maternal Sensory Intervention, Newborn, Neonatal Intensive Care Unit, Physiological Parameters, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Jul 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 was designed to determine the effects of maternal sensory interventions (kangaroo care, lullabies, and maternal tactile-auditory soothing) on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the neonatal intensive care unit.
Detailed description
Sleep organization and physiological stability are essential indicators of neurological development and overall health in newborns. However, newborns hospitalized in neonatal intensive care units (NICUs) are frequently exposed to environmental stressors, including excessive noise, continuous lighting, routine caregiving activities, and medical procedures, which may adversely affect sleep quality and physiological stability. Maternal sensory interventions are non-pharmacological developmental care approaches that may promote relaxation, improve sleep organization, and support physiological regulation through tactile and auditory stimulation. This study is designed as a single-center, four-arm, parallel-group randomized controlled trial to evaluate the effects of maternal sensory interventions on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the NICU. Eligible clinically stable newborns will be randomly assigned in a 1:1:1:1 ratio to one of four groups: kangaroo care, maternal lullaby, maternal tactile-auditory soothing, or routine care (control). Following routine midday care and feeding, newborns in the kangaroo care group will receive uninterrupted skin-to-skin contact with their mothers for 60 minutes. In the maternal lullaby group, mothers will sing a lullaby of their choice for 15 minutes. In the maternal tactile-auditory soothing group, mothers will gently provide rhythmic tactile stimulation to the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds ("pış pış") for 15 minutes. Infants in the control group will receive routine NICU care without additional intervention. All newborns will be monitored for a total of 60 minutes following the intervention or routine care. Sleep-wake states will be continuously assessed using the Bispectral Index (BIS) monitor. Physiological parameters, including heart rate, respiratory rate, and oxygen saturation, will be recorded at predetermined time points using standard patient monitoring equipment. Sleep onset latency, as well as the duration of wakefulness, REM sleep, light sleep, and deep sleep, will be calculated from BIS recordings. The findings of this study are expected to provide evidence regarding the effectiveness of maternal sensory interventions in improving sleep organization and physiological stability in newborns and to contribute to the development of evidence-based developmental care practices in neonatal intensive care units.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel groups: Kangaroo Care, Maternal Lullaby, Maternal Tactile-Auditory Soothing, or Routine Care. Each participant will receive only the intervention assigned to their group, and outcomes will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group 1: Kangaroo Care | Experimental | Behavioral: Kangaroo CareParticipants assigned to this group will receive kangaroo care provided by their mothers for 60 minutes following routine midday care and feeding. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes. |
| Intervention Group 2: Maternal Lullaby | Experimental | Behavioral: Maternal LullabyParticipants assigned to this group will receive maternal lullaby intervention for 15 minutes following routine midday care and feeding. Mothers will sing a lullaby of their choice while the infant remains in the crib. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes. |
| Intervention Group 3: Maternal Tactile-Auditory Soothing | Experimental | Behavioral: Maternal Tactile-Auditory SoothingParticipants assigned to this group will receive maternal tactile-auditory soothing for 15 minutes following routine midday care and feeding. Mothers will provide gentle rhythmic tactile stimulation to the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds ("pış pış"). Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes. |
| Routine Care (Control) | No intervention | –Participants assigned to this group will receive routine neonatal intensive care without any additional sensory intervention. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes following routine care. |
Who may qualify
- Ages
- 35 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Gestational age between 35 and 42 completed weeks.
- Birth weight between 2,000 and 4,200 grams.
- Clinically stable newborn admitted to the neonatal intensive care unit.
- Spontaneous breathing without the need for mechanical ventilation.
- Not receiving sedative medications.
Key exclusion criteria (8 listed)
- Five-minute Apgar score <4.
- Requirement for advanced resuscitation after birth.
- Presence of a major congenital anomaly.
- Requirement for invasive intervention involving the head region.
- Diagnosed central nervous system dysfunction or neurological disorder.
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 |
|---|---|---|
| Kangaroo CareKangaroo care will be provided by the mother for 60 minutes following routine midday care and feeding. The newborn, wearing only a diaper, will be placed in an upright skin-to-skin position on the mother's bare chest. The infant's head will be positioned to maintain airway patency, and a light blanket will be used to maintain thermal stability. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored throughout the 60-minute observation period. | Behavioural | Intervention Group 1: Kangaroo Care |
| Maternal LullabyFollowing routine midday care and feeding, mothers will sing a lullaby of their choice to their newborn for 15 minutes while the infant remains in the crib. The lullaby will be performed in a soft, soothing voice at a sound level not exceeding 45-50 dB. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes. | Behavioural | Intervention Group 2: Maternal Lullaby |
| Maternal Tactile-Auditory SoothingFollowing routine midday care and feeding, mothers will provide gentle rhythmic tactile stimulation by softly stroking the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds ("pış pış") for 15 minutes. The sound level will not exceed 45-50 dB. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes. | Behavioural | Intervention Group 3: Maternal Tactile-Auditory Soothing |
Primary outcome
Sleep-Wake States Assessed by Bispectral Index
Time frame: During the 60-minute observation period following routine midday care and feeding
Sleep-wake states will be assessed continuously using the Bispectral Index (BIS), a processed electroencephalographic monitoring system with scores ranging from 0 to 100, where higher scores indicate greater wakefulness and lower scores indicate deeper levels of sleep. BIS values will be classified as wakefulness (91-100), REM sleep (80-90), light sleep (55-79), and deep sleep (0-54). The duration and percentage of time spent in each sleep-wake state will be calculated during the 60-minute observation period.
Sleep Onset Latency
Time frame: From the beginning of the intervention until sleep onset, assessed within 60 minutes
Sleep onset latency will be defined as the time, in minutes, from the beginning of the assigned intervention or routine care until the BIS value first decreases below 91, indicating transition from wakefulness to sleep.
Mean Bispectral Index Score
Time frame: During the 60-minute observation period
The mean Bispectral Index (BIS) score will be calculated from values recorded at one-minute intervals throughout the 60-minute monitoring period. BIS scores range from 0 to 100, with higher scores indicating greater wakefulness and lower scores indicating deeper sleep.
3 secondary outcomes
Heart Rate
Time frame: Baseline, 15, 30, and 60 minutes after the intervention or routine care
Respiratory Rate
Time frame: Baseline, 15, 30, and 60 minutes after the intervention or routine care
Oxygen Saturation (SpO₂)
Time frame: Baseline, 15, 30, and 60 minutes after the intervention or routine care
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 27 Jul 2026.
- Results publication: PubMed 31397094Yasova Barbeau D, Krueger C, Huene M, Copenhaver N, Bennett J, Weaver M, Weiss MD. Heart rate variability and inflammatory markers in neonates with hypoxic-ischemic encephalopathy. Physiol Rep. 2019 Aug;7(15):e14110. doi: 10.14814/phy2.14110.
- Results publicationintensive care unit. Medicine, 100(43), e27587. https://doi.org/10.1097/md.0000000000027587 Kahraman, A., Başbakkal, Z., & Yalaz, M. (2014). Turkish validity and reliability of the Newborn Comfort Behavior Scale. International Refereed Journal of Nursing Research, 1(2), 1-11.
- Results publication: PubMed 34713833Huang Q, Lai X, Liao J, Tan Y. Effect of non-pharmacological interventions on sleep in preterm infants in the neonatal intensive care unit: A protocol for systematic review and network meta-analysis. Medicine (Baltimore). 2021 Oct 29;100(43):e27587. doi: 10.1097/MD.0000000000027587.
- Results publication: PubMed 35634367Caba-Flores MD, Ramos-Ligonio A, Camacho-Morales A, Martinez-Valenzuela C, Viveros-Contreras R, Caba M. Breast Milk and the Importance of Chrononutrition. Front Nutr. 2022 May 12;9:867507. doi: 10.3389/fnut.2022.867507. eCollection 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Care, Maternal Lullaby and Maternal Tactile-Auditory Soothing in people with Neonatal Intensive Care Unit and Hospitalized Newborn, run by Kirsehir Ahi Evran Universitesi 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 6 inclusion and 8 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 27 Jul 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 Edanur Tar Bolacali, PhD (+908504412483, edanurtar.1107@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep-Wake States Assessed by Bispectral Index (time frame: During the 60-minute observation period following routine midday care and feeding). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07725094, which also lists 4 linked publications.
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 27 Jul 2026.