The Impact of the SENSE Program on NICU

Not Applicable

Not yet recruiting

• Conditions: Sensory Experiences; Individualized Developmental Care; Pre-Term
• Interventions: Other: SENSE group

• Registration Number: NCT06354517
• Lead Sponsor: Yuksek Ihtisas University

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.

Study Timeline

• Study First Submitted: 2024-03-29
• Status Verified: 2024-04
• Study Start: 2024-04-01
• Study First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SENSE group	SENSE 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.

Primary Outcome Measures

Name	Time	Method
Edinburgh Postnatal Depression Scale	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	24 hours	It will be applied twice: when the baby is first admitted to the clinic and before discharge.
Hammersmıth Neonatal Neurologıcal Examınatıon	24 hours	It will be applied twice: when the baby is first admitted to the clinic and before discharge.
State-trait Anxiety Inventory	24 hours	It will be applied twice: when the baby is first admitted to the clinic and before discharge.

Trial Locations

Locations (1)

Yuksek Ihtisas University; 🇹🇷 Ankara, Turkey