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The Impact of the SENSE Program on NICU

The Impact of the SENSE Program on Parent and Newborn

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06354517
Enrollment
60
Registered
2024-04-09
Start date
2024-04-01
Completion date
2025-05-30
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Individualized Developmental Care, Pre-Term, Sensory Experiences

Brief 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.

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.

Interventions

OTHERSENSE group

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.

Sponsors

Yuksek Ihtisas University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Weeks to 42 Weeks
Healthy volunteers
No

Inclusion criteria

* Being in the first week of life

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Edinburgh Postnatal Depression Scale24 hoursIt will be applied twice: when the baby is first admitted to the clinic and before discharge.
Hammersmıth Neonatal Neurologıcal Examınatıon24 hoursIt will be applied twice: when the baby is first admitted to the clinic and before discharge.
Parental Stress Scale: Neonatal Intensive Care Unit24 hoursIt will be applied twice: when the baby is first admitted to the clinic and before discharge.
State-trait Anxiety Inventory24 hoursIt will be applied twice: when the baby is first admitted to the clinic and before discharge.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMüjde ÇALIKUŞU İNCEKAR, PhD
mujdecalikusu@gmail.com0905547860346

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026