The Effect of Simulated Intrauterine Sound Applied to Preterms

NCT ID: NCT05806320

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-15
• Study Completion Date: 2022-05-31

Brief 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.

Detailed Description

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. It is known that the preterm infants hear the sounds from the extrauterine and respond to these sounds after the 26th gestational week. The types of the sounds and the level of the noise in the NICU is quite different from the uterus environment. The ambient noise composed of the ventilators, monitors, pagers and alarms of NICU take place of the low-frequency maternal voices in the amniotic environment. For this reason, the preterm infants lack the normal audial stimulants and they are disturbed by the sounds in the NICU environment. As a result, the development of the auditory and language skills and the socio-emotional development of the infants may get harmed. The recent evidences have suggested that the auditory learning and voice recognition experiences of the infants are based on their prenatal experiences. Therefore, it is quite important to make the preterm infants listen to their mothers' voice and the heart rate sound which they are lack of due to their preterm birth and therefore keeping them away from the sounds of the NICU environment.

In the light of this information, 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.

Conditions

Neonatal Intensive Care; Preterm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intrauterine Sound Listening Group 1

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Intrauterine Sound Listening Group 2

Intervention Type: OTHER

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.

Control 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. Babies in this group were followed up at specified time intervals without any intervention.

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. 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 hours; 11:00-11.30/13.45-14.15/17.00-17.30 hours; 11.30-11.45/14.15- 14.30/17.30-17.45.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Control 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. Babies in this group were followed up at specified time intervals without any intervention.

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. 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 hours; 11:00-11.30/13.45-14.15/17.00-17.30 hours; 11.30-11.45/14.15- 14.30/17.30-17.45.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being at -26-36,6 GW,
• In the first week after birth,
• Absence of a congenital anomaly,
• Not being sedated,
• If the baby has been given eye drops, 4-6 hours have passed,
• 20-30 minutes have passed since the last painful attempt

Exclusion Criteria

• Below 26 GW or above 37 GW,
• Absence in the first week after birth,
• Having a congenital anomaly,
• Being sedated,
• The baby is receiving phototherapy

• Minimum Eligible Age: 26 Weeks
• Maximum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Birsen Mutlu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Müjde ÇALIKUŞU İNCEKAR, PhD

Role: PRINCIPAL_INVESTIGATOR

Yuksek Ihtisas University

Gökhan DENEÇ, PhD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Technical University

Ayhan TAŞTEKİN, MD

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

Istanbul University-Cerrahpaşa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IUC-B-M-001

Identifier Type: -

Identifier Source: org_study_id