The Effect of Simulated Intrauterine Sound Applied to Preterms

NCT05806320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-10

No results posted yet for this study

Summary

Preterm infants lack intrauterine sounds suitable for their development as they are born early. In addition, they are exposed to many unfamiliar sounds for weeks or months in the neonatal intensive care unit (NICU) where their follow-up and care are continued. , one of evidences is that the maternal voices have an effect on the physiological, neurobehavioral and autonomic functions of the preterm infants. Also, the fact that the maternal voice is a non-pharmacological and non-invasive application has importance for the preterm infant. Therefore, considering the optimal well-being of the infant, it is predicted that using the applications that simulate the extrauterine environment of the preterm infant to the intrauterine environment would decrease the stress behaviors of the infants and would provide the physiological values to be followed up in the positive direction, and as a result of these, it would contribute to supporting the recovery and shortening the discharge period. The study was planned as a randomized controlled experimental design in order to determine the effect of the sound applied on the 26-37 week-old preterm infants on their heart rate, oxygen saturation and comfort level.

Conditions

  • Neonatal Intensive Care
  • Preterm

Interventions

OTHER

Intrauterine Sound Listening Group 1

This group consisted of 15 infants with 26-32,6 GW. A total of one hour of noise measurement was made inside and outside the incubator before, during and after the procedure. The babies were listened to the sound obtained in 3 time periods. If the baby is fed enterally, the feeding of the baby was completed at 10.15/13.00/16.15 before the application, the baby was placed in the prone position and the baby was rested for 30 minutes to ensure gastric emptying. Before the procedure, the baby was watched with a monitor device and recorded on video between 10.45-11.00/13.30-13.45/16.45-17.00. During the baby procedure, uterine sound was listened to the baby in the prone position monitored with a monitor device and recorded on video between 11:00-11.30/13.45-14.15/17.00-17.30 hours. After the procedure, the baby was watched with a monitor device and recorded on video between 11.30-11.45/14.15 and 14.30/17.30-17.45.

OTHER

Intrauterine Sound Listening Group 2

This group consisted of 15 infants with 33-36,6 GW. A total of one hour of noise measurement was made inside and outside the incubator before, during and after the procedure. The babies were listened to the sound obtained in 3 time periods. If the baby is fed enterally, the feeding of the baby was completed at 10.15/13.00/16.15 before the application, the baby was placed in the prone position and the baby was rested for 30 minutes to ensure gastric emptying. Before the procedure, the baby was watched with a monitor device and recorded on video between 10.45-11.00/13.30-13.45/16.45-17.00. During the baby procedure, uterine sound was listened to the baby in the prone position monitored with a monitor device and recorded on video between 11:00-11.30/13.45-14.15/17.00-17.30 hours. After the procedure, the baby was watched with a monitor device and recorded on video between 11.30-11.45/14.15 and 14.30/17.30-17.45.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Müjde ÇALIKUŞU İNCEKAR, PhD · Yuksek Ihtisas University

  • Gökhan DENEÇ, PhD · Istanbul Technical University

  • Ayhan TAŞTEKİN, MD · Medipol University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
26 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05806320 on ClinicalTrials.gov