The Impact of the SENSE Program on NICU

NCT06354517 | Not Yet Recruiting

• 1 other identifier: YIU-M-CI-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre-Term; Individualized Developmental Care; Sensory Experiences

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

SENSE group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

SENSE group 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.

SENSE group

Eligibility Criteria

• Age: 24 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being in the first week of life

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuksek Ihtisas University: lead

Study Sites (1)

Yuksek Ihtisas University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Social Cohesion

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Neighborhood Characteristics; Residence Characteristics; Demography; Population Characteristics; Social Integration; Community Resources; Health Care Economics and Organizations; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Sevim SAVAŞER, PhD

  Biruni University

  PRINCIPAL INVESTIGATOR

• Ahu ÇIRLAK, PhD

  Ankara Guven Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Müjde ÇALIKUŞU İNCEKAR, PhD

CONTACT

0905547860346; mujdecalikusu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 9, 2024
• Study Start: April 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

TU (1)