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The Impact of the SENSE Program on NICU

Y

Yuksek Ihtisas University

Status

Not yet enrolling

Conditions

Sensory Experiences
Pre-Term
Individualized Developmental Care

Treatments

Other: SENSE group

Study type

Interventional

Funder types

Other

Identifiers

NCT06354517
YIU-M-CI-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

24 to 42 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

SENSE group
Experimental group
Description:
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.
Treatment:
Other: SENSE group
Control group
No Intervention group
Description:
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.

Trial contacts and locations

1

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Central trial contact

Müjde ÇALIKUŞU İNCEKAR, PhD

Data sourced from clinicaltrials.gov

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