Effect of Therapeutic Touch and Mother's Voice on Pain and Comfort Level During Nasal CPAP Application
NCT ID: NCT05577793
Last Updated: 2022-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2019-04-15
2020-08-14
Brief Summary
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Detailed Description
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Design and Method: The study, which used a randomized controlled trial, included 124 preterm neonatal infants a gestational age of 28- 37 weeks and received nasal CPAP. The infants were treated with Mother's Voice, Therapeutic Touch, and Mother's Voice+ Therapeutic Touch. The Neonatal Infant Pain Scale (NIPS) and Premature Infant Comfort Scale (PICS) scores of the infants were measured before, during and after the nasal CPAP application.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Mother's Voice
The mothers were asked to sing lullabies, and their voices were recorded in a quiet environment. Which lullaby they would sing was left to the mothers' discretion, and the audio recording process took an average of 2-3 minutes. The voice recordings taken were applied for a total of 15 minutes before, during and after the nasal CPAP application.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Therapeutic Touch
Therapeutic touch was started 5 minutes before nasal prongs were placed, and was applied for 5 minutes during the application, and continued for another 5 minutes after the nasal prongs were placed. The method was applied for a total of 15 minutes as 5 minutes of hand resting, 5 minutes of gentle caressing and 5 more minutes of hand resting.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Mother's Voice +Therapeutic Touch
Both applications were applied together for 15 minutes.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Control
The premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Therapeutic Touch
Therapeutic touch was started 5 minutes before nasal prongs were placed, and was applied for 5 minutes during the application, and continued for another 5 minutes after the nasal prongs were placed. The method was applied for a total of 15 minutes as 5 minutes of hand resting, 5 minutes of gentle caressing and 5 more minutes of hand resting.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Mother's Voice
The audio recording was made to listen to the baby for 15 minutes during the nasal CPAP application. The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Mother's Voice +Therapeutic Touch
Both applications were applied together for 15 minutes.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Control
The premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Mother's Voice+Therapeutic Touch
Both applications were applied together for 15 minutes.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Mother's Voice
The audio recording was made to listen to the baby for 15 minutes during the nasal CPAP application. The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Therapeutic Touch
Therapeutic touch was started 5 minutes before nasal prongs were placed, and was applied for 5 minutes during the application, and continued for another 5 minutes after the nasal prongs were placed. The method was applied for a total of 15 minutes as 5 minutes of hand resting, 5 minutes of gentle caressing and 5 more minutes of hand resting.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Control
The premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Control
The premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
No interventions assigned to this group
Interventions
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Mother's Voice
The audio recording was made to listen to the baby for 15 minutes during the nasal CPAP application. The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Therapeutic Touch
Therapeutic touch was started 5 minutes before nasal prongs were placed, and was applied for 5 minutes during the application, and continued for another 5 minutes after the nasal prongs were placed. The method was applied for a total of 15 minutes as 5 minutes of hand resting, 5 minutes of gentle caressing and 5 more minutes of hand resting.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Mother's Voice +Therapeutic Touch
Both applications were applied together for 15 minutes.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Control
The premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* being in the gestational ages of 28 to 37 weeks
* having nasal CPAP
Exclusion Criteria
* having comorbidity
* receiving sedation or analgesics
* having congenital anomaly
* receiving extra invasive procedures or surgical intervention
* being diagnosed with hearing loss
28 Weeks
37 Weeks
ALL
Yes
Sponsors
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Ayşe Belpınar
OTHER
Responsible Party
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Ayşe Belpınar
Lecturer
Principal Investigators
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Ayşe Belpınar, Msc
Role: PRINCIPAL_INVESTIGATOR
Bozok University
Emriye Hilal Yayan, Phd
Role: PRINCIPAL_INVESTIGATOR
Inonu University
Locations
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Cengiz Gökçek Gynecology, Obstetrics and Pediatrics Hospital
Gaziantep, , Turkey (Türkiye)
Countries
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Other Identifiers
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ABelpinar
Identifier Type: -
Identifier Source: org_study_id
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