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The Effect of Simulated Intrauterine Sound Applied to Preterms

Primary Purpose

Neonatal Intensive Care, Preterm

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intrauterine Sound Listening Group 1
Intrauterine Sound Listening Group 2
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neonatal Intensive Care focused on measuring Sound

Eligibility Criteria

26 Weeks - 36 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul University-Cerrahpaşa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Intrauterine Sound Listening Group 1

Intrauterine Sound Listening Group 2

Control Group 1

Control Group 2

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Newborn Comfort Behavior Scale (COMFORTneo)
The comfort scale (CS) is a scale developed by Ambuel et al., (1992) in order to assess the distress of the children taking the mechanic ventilation support and followed up in the pediatric intensive care unit. The scale was revised by Van Dijk et al. (2009) and developed only for assessing behaviors in the newborns without the physiological parameters. While the lowest score to be obtained from the scale is 6, the highest score is 30. A high score indicates that the infant does not feel comfortable and needs interventions to provide comfort and also 4-6 points indicate moderate pain and distress and 7-10 points indicate severe pain and distress. Kahraman et al., (2014) conducted the Turkish validity and reliability study of the scale with the infants of 24-42 GW.
Heart rate
The heart rate of the infants will measured as monitorized.
Peripheral oxygen saturation level
The peripheral oxygen saturation level of the infants will measured as monitorized.
Noise level
Noise measurement will be made with noise meter from the outside of the incubator during the hours when the study would be conducted.
Sound level
In order for the baby to hear the sound created in the incubator; Before each procedure, a noise measuring device was placed in the incubator and the level of sound heard by the baby in the incubator was recorded as dBA. Then the Mp3 device is set to the appropriate volume.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2023
Last Updated
March 28, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05806320
Brief Title
The Effect of Simulated Intrauterine Sound Applied to Preterms
Official Title
The Effect of Simulated Intrauterine Sound Applied to Preterms on Heart Rate, Oxygen Saturation and Comfort Level
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Intensive Care, Preterm
Keywords
Sound

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrauterine Sound Listening Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Intrauterine Sound Listening Group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group 1
Arm Type
No Intervention
Arm Description
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.
Arm Title
Control Group 2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intrauterine Sound Listening Group 1
Intervention Description
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
Intervention Name(s)
Intrauterine Sound Listening Group 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Newborn Comfort Behavior Scale (COMFORTneo)
Description
The comfort scale (CS) is a scale developed by Ambuel et al., (1992) in order to assess the distress of the children taking the mechanic ventilation support and followed up in the pediatric intensive care unit. The scale was revised by Van Dijk et al. (2009) and developed only for assessing behaviors in the newborns without the physiological parameters. While the lowest score to be obtained from the scale is 6, the highest score is 30. A high score indicates that the infant does not feel comfortable and needs interventions to provide comfort and also 4-6 points indicate moderate pain and distress and 7-10 points indicate severe pain and distress. Kahraman et al., (2014) conducted the Turkish validity and reliability study of the scale with the infants of 24-42 GW.
Time Frame
5 minutes
Title
Heart rate
Description
The heart rate of the infants will measured as monitorized.
Time Frame
1 minutes
Title
Peripheral oxygen saturation level
Description
The peripheral oxygen saturation level of the infants will measured as monitorized.
Time Frame
1 minutes
Title
Noise level
Description
Noise measurement will be made with noise meter from the outside of the incubator during the hours when the study would be conducted.
Time Frame
1 minutes
Title
Sound level
Description
In order for the baby to hear the sound created in the incubator; Before each procedure, a noise measuring device was placed in the incubator and the level of sound heard by the baby in the incubator was recorded as dBA. Then the Mp3 device is set to the appropriate volume.
Time Frame
1 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Müjde ÇALIKUŞU İNCEKAR, PhD
Organizational Affiliation
Yuksek Ihtisas University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gökhan DENEÇ, PhD
Organizational Affiliation
Istanbul Technical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayhan TAŞTEKİN, MD
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpaşa
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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The Effect of Simulated Intrauterine Sound Applied to Preterms

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