Pre-TermNCT06354517
The Impact of the SENSE Program on NICU
A study testing SENSE group in people with Pre-Term and Individualized Developmental Care, run by Yuksek Ihtisas University at 1 site in Turkey (Türkiye).
Trial summary
The SENSE program will be applied to babies receiving treatment in the neonatal intensive care unit and the effect of the application on the baby and parents will be examined. Read more about this study
- Who is it for?
- Ages 24 to 42 weeks
- Conditions the study is for
- Pre-Term, Individualized Developmental Care, Sensory Experiences
- What is being tested?
- SENSE group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 24 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being in the first week of life
Who cannot join
- Congenital anomaly,
- Preterm babies who are not predicted to survive,
- Babies who cannot be followed regularly,
- Parent having a psychiatric problem
- Parents who wish to withdraw from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of the SENSE Program on Parent and Newborn
The SENSE program will be applied to babies receiving treatment in the neonatal intensive care unit and the effect of the application on the baby and parents will be examined.
Read the detailed description
For the growth and health of the baby, the intrauterine environment provides the fetus with protective physical barriers and sensory exposures timed appropriately for its development. These early exposures occur during sensory development in the intrauterine environment, and there are differences in the timing of development of each sense. When the baby is born prematurely, the intrauterine environment is replaced by the Neonatal Intensive Care Unit environment. The sensory environment of the preterm baby includes the experiences of touch, movement, smell, sound, light, frequent nociceptive pain and disruption of sleep. The mismatch between the infant's underdeveloped coping skills and the stimulating NICU environment can cause physiological imbalance, negatively impact growth and development, and ultimately predispose to the development of long-term neurodevelopmental consequences. Although harmful sensory exposures can negatively affect the development of the preterm baby, appropriate positive sensory exposures positively affect brain development.
- Being tested
- SENSE group
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSE groupOther
Parents of babies in this group will be given SENSE program training. After the training, parents will care for their babies within the scope of the SENSE program. These babies will receive care from their parents with positive sensory exposures within the scope of the SENSE program from admission to the clinic until discharge. Data collection forms will be administered to babies and their parents.
| Study group | Role | What they receive |
|---|---|---|
| SENSE group | Experimental | Parents of babies in this group will be given SENSE program training. After the training, parents will care for their babies within the scope of the SENSE program. These babies will receive care from their parents with positive sensory exposures within the scope of the SENSE program from admission to the clinic until discharge. Data collection forms will be administered to babies and their parents. Receives: Other: SENSE group |
| Control group | No intervention | The SENSE program will not be applied to the parents of babies in this group. These babies will receive the routine care of the clinic. These babies will be monitored from admission to the clinic until discharge. Data collection forms will be administered to infants and parents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hammersmıth Neonatal Neurologıcal Examınatıon
It will be applied twice: when the baby is first admitted to the clinic and before discharge.
Measured: 24 hours
Parental Stress Scale: Neonatal Intensive Care Unit
It will be applied twice: when the baby is first admitted to the clinic and before discharge.
Measured: 24 hours
State-trait Anxiety Inventory
It will be applied twice: when the baby is first admitted to the clinic and before discharge.
Measured: 24 hours
Edinburgh Postnatal Depression Scale
It will be applied twice: when the baby is first admitted to the clinic and before discharge.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-TermStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mujde CALIKUSU INCEKAR, Yuksek Ihtisas University
- Investigators
- Sevim SAVAŞER, PhD, Principal investigator, Biruni UniversityAhu ÇIRLAK, PhD, Principal investigator, Ankara Guven Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354517
- Sponsor's protocol ID
- YIU-M-CI-003
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Calikusu Incekar M, Savaser S, Cirlak A, Keceli MS. The effect of supporting and enhancing NICU sensory experiences (SENSE(R)) program on maternal stress, anxiety, and depressive symptoms among mothers: A quasi-experimental study. J Pediatr Nurs. 2026 Sep 8;91:681-690. doi: 10.1016/j.pedn.2026.08.062. Online ahead of print.
PubMed 42710388
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the SENSE Program on Parent and Newborn
- ClinicalTrials.gov ID
- NCT06354517
- Acronym / sponsor ID
- YIU-M-CI-003
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yuksek Ihtisas UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 9 Apr 2024 (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.
The SENSE program will be applied to babies receiving treatment in the neonatal intensive care unit and the effect of the application on the baby and parents will be examined.
Detailed description
For the growth and health of the baby, the intrauterine environment provides the fetus with protective physical barriers and sensory exposures timed appropriately for its development. These early exposures occur during sensory development in the intrauterine environment, and there are differences in the timing of development of each sense. When the baby is born prematurely, the intrauterine environment is replaced by the Neonatal Intensive Care Unit environment. The sensory environment of the preterm baby includes the experiences of touch, movement, smell, sound, light, frequent nociceptive pain and disruption of sleep. The mismatch between the infant's underdeveloped coping skills and the stimulating NICU environment can cause physiological imbalance, negatively impact growth and development, and ultimately predispose to the development of long-term neurodevelopmental consequences. Although harmful sensory exposures can negatively affect the development of the preterm baby, appropriate positive sensory exposures positively affect brain development.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SENSE group | Experimental | Other: SENSE groupParents of babies in this group will be given SENSE program training. After the training, parents will care for their babies within the scope of the SENSE program. These babies will receive care from their parents with positive sensory exposures within the scope of the SENSE program from admission to the clinic until discharge. Data collection forms will be administered to babies and their parents. |
| Control group | No intervention | –The SENSE program will not be applied to the parents of babies in this group. These babies will receive the routine care of the clinic. These babies will be monitored from admission to the clinic until discharge. Data collection forms will be administered to infants and parents. |
Who may qualify
- Ages
- 24 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Being in the first week of life
Key exclusion criteria (5 listed)
- Congenital anomaly,
- Preterm babies who are not predicted to survive,
- Babies who cannot be followed regularly,
- Parent having a psychiatric problem
- Parents who wish to withdraw from the study
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 |
|---|---|---|
| SENSE groupParents of babies in this group will be given SENSE program training. After the training, parents will care for their babies within the scope of the SENSE program. These babies will receive care from their parents with positive sensory exposures within the scope of the SENSE program from admission to the clinic until discharge. Data collection forms will be administered to babies and their parents. | Other | SENSE group |
Primary outcome
Hammersmıth Neonatal Neurologıcal Examınatıon
Time frame: 24 hours
It will be applied twice: when the baby is first admitted to the clinic and before discharge.
Parental Stress Scale: Neonatal Intensive Care Unit
Time frame: 24 hours
It will be applied twice: when the baby is first admitted to the clinic and before discharge.
State-trait Anxiety Inventory
Time frame: 24 hours
It will be applied twice: when the baby is first admitted to the clinic and before discharge.
Edinburgh Postnatal Depression Scale
Time frame: 24 hours
It will be applied twice: when the baby is first admitted to the clinic and before discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 42710388Calikusu Incekar M, Savaser S, Cirlak A, Keceli MS. The effect of supporting and enhancing NICU sensory experiences (SENSE(R)) program on maternal stress, anxiety, and depressive symptoms among mothers: A quasi-experimental study. J Pediatr Nurs. 2026 Sep 8;91:681-690. doi: 10.1016/j.pedn.2026.08.062. Online ahead of print.
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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. This study is not recruiting at the moment.
Sevim SAVAŞER, PhD principal investigator
Biruni University
Ahu ÇIRLAK, PhD principal investigator
Ankara Guven Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSE group in people with Pre-Term and Individualized Developmental Care, run by Yuksek Ihtisas 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Müjde ÇALIKUŞU İNCEKAR, PhD (0905547860346, mujdecalikusu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hammersmıth Neonatal Neurologıcal Examınatıon (time frame: 24 hours). The study lists 4 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 NCT06354517, which also lists 1 linked publication.
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 9 Apr 2024.