The Impact of the SENSE Program on NICU

NCT ID: NCT06354517

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-05-30

Brief Summary

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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

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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.

Conditions

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Pre-Term Individualized Developmental Care Sensory Experiences

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SENSE group

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuksek Ihtisas University

OTHER

Sponsor Role lead

Responsible Party

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Mujde CALIKUSU INCEKAR

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sevim SAVAŞER, PhD

Role: PRINCIPAL_INVESTIGATOR

Biruni University

Ahu ÇIRLAK, PhD

Role: PRINCIPAL_INVESTIGATOR

Ankara Guven Hospital

Locations

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Yuksek Ihtisas University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Müjde ÇALIKUŞU İNCEKAR, PhD

Role: CONTACT

0905547860346

Other Identifiers

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YIU-M-CI-003

Identifier Type: -

Identifier Source: org_study_id

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