The Impact of the SENSE Program on NICU

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pre-Term; Individualized Developmental Care; Sensory Experiences
• Intervention / Treatment: Other: SENSE group

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Müjde ÇALIKUŞU İNCEKAR, PhD; Phone Number: 0905547860346; Email: mujdecalikusu@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Yuksek Ihtisas University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Control group; 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 the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yuksek Ihtisas University
• Investigators: Principal Investigator: Sevim SAVAŞER, PhD, Biruni University; Principal Investigator: Ahu ÇIRLAK, PhD, Ankara Güven Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: YIU-M-CI-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No