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Not yet recruitingNCT06354517Updated Apr 9, 2024

The Impact of the SENSE Program on NICU

An interventional study of SENSE group in Pre-Term, Individualized Developmental Care and Sensory Experiences, sponsored by Yuksek Ihtisas University. Not yet recruiting at 1 site in Turkey. Open to participants aged 24 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by Yuksek Ihtisas University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
24 Weeks to 42 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pre-Term
  • Individualized Developmental Care
  • Sensory Experiences

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03

In context

Premature Birth

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's planned enrollment of 60 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Yuksek Ihtisas University is the lead sponsor of 22 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Weeks to 42 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being in the first week of life

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • OtherSENSE 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.

06

What researchers measure

Primary outcomes

  1. Hammersmıth Neonatal Neurologıcal Examınatıon

    It will be applied twice: when the baby is first admitted to the clinic and before discharge.

    Time frame: 24 hours

  2. Parental Stress Scale: Neonatal Intensive Care Unit

    It will be applied twice: when the baby is first admitted to the clinic and before discharge.

    Time frame: 24 hours

  3. State-trait Anxiety Inventory

    It will be applied twice: when the baby is first admitted to the clinic and before discharge.

    Time frame: 24 hours

  4. Edinburgh Postnatal Depression Scale

    It will be applied twice: when the baby is first admitted to the clinic and before discharge.

    Time frame: 24 hours

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06354517
Lead sponsor
Yuksek Ihtisas University
Responsible party
Mujde CALIKUSU INCEKAR (Associate Professor, Yuksek Ihtisas University) — Principal investigator
First posted
Apr 9, 2024
Start date
Apr 1, 2024 (estimated)
Primary completion
May 30, 2025 (estimated)
Completion
May 30, 2025 (estimated)
Last update
Apr 9, 2024

Study contacts

Müjde ÇALIKUŞU İNCEKAR, PhD
Contact
mujdecalikusu@gmail.com
0905547860346
Sevim SAVAŞER, PhD
principal investigator · Biruni University
Ahu ÇIRLAK, PhD
principal investigator · Ankara Guven Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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