The Impact of the SENSE Program on NICU

Pre-Term Clinical Trial

Official title:

The Impact of the SENSE Program on Parent and Newborn

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06354517
• Other study ID #: YIU-M-CI-003
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: April 2024
• Source: Yuksek Ihtisas University
• Contact: Müjde ÇALIKUSU INCEKAR, PhD
• Phone: 0905547860346
• Email: mujdecalikusu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 42 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Pre-Term
• Premature Birth

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Yuksek Ihtisas University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Yuksek Ihtisas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hammersmith Neonatal Neurological Examination	It will be applied twice: when the baby is first admitted to the clinic and before discharge.	24 hours
Primary	Parental Stress Scale: Neonatal Intensive Care Unit	It will be applied twice: when the baby is first admitted to the clinic and before discharge.	24 hours
Primary	State-trait Anxiety Inventory	It will be applied twice: when the baby is first admitted to the clinic and before discharge.	24 hours
Primary	Edinburgh Postnatal Depression Scale	It will be applied twice: when the baby is first admitted to the clinic and before discharge.	24 hours