Efficacy of Music Listening to Shortening Time for Biophysical Profile

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the timeing which assume for assesment of BPP in low risk pregnancy. The main question is the music can be shoetening the timing for BPP? Participants will in study froup will listening the music via headphone before and during the assessment and compre to control gruop which not listening to music during asseeement.

Detailed Description
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A single-blind randomized controlled trial conducted from February 2021 to December 2022. The study population consisted of 60 pregnant women with between 18 and 35 years old with gestational age of 32 weeks. An abdominal ultrasound was performed while listening to one song while wearing headphones in the experimental group preceding the biophysical profile assessment. As part of the control group, the same equipment was used and the same assessment protocol was followed, but music was not played during the test.

Official Title
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Efficacy of Music Listening to Shortening Time for Biophysical Profile

Conditions
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Fetal Status, Nonreassuring

Intervention / Treatment
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* Diagnostic Test: Trans abdominal ultrasound for assess biophysical profile


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single pregnancy (Singleton) Gestational age from 32 weeks onward Pregnant women do not have underlying diseases such as pre-gestational diabetes. high blood pressure No abnormalities in the fetus were found, such as fetal deformities. Exclusion Criteria: Pregnant women receiving certain drugs or substances that affect the interpretation of the Biophysical Profile (BPP), e.g., sleeping pills, cigarettes. Pregnant women have hearing problems. or hearing impaired Pregnant women who are unable to wear headphones, e.g., otitis externa - Pregnant women with body mass index greater than 30 kg/m2 prior to pregnancy Uterine contractions were observed during the examination
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: the participants were purpostive sampling, and devided into two groups. The study group listening to music before and suring the assessment while the control gruop will not listening to music.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lable litter A (Study group)<br>The sealed opaque brown envelope contains a case record form and the letter A paper for listening to the music before and during the BPP assessment (study group), which cannot be visible from the outside. | Diagnostic Test: Trans abdominal ultrasound for assess biophysical profile<br>* The biophysical profile (BPP) was developed as a method of integrating real-time observation of the fetus in an intrauterine environment. Manning et al introduced the BPP test in 1980, and since then it has been widely used as a comprehensive assessment tool for both acute and chronic fetal health and fetal congenital malformations in the antepartum period which is a method that uses an overview of 5 key indicators, namely fetal tone, fetal breathing, fetal movement, deep ventricular pocket and NST, thus making it more accurate than either viewing.<br>|
| Placebo Comparator: Lable litter B (control group)<br>The sealed opaque brown envelope contains a case record form and the letter B for not listening to the music before and during the BPP assessment (control group), which cannot be visible from the outside. | Diagnostic Test: Trans abdominal ultrasound for assess biophysical profile<br>* The biophysical profile (BPP) was developed as a method of integrating real-time observation of the fetus in an intrauterine environment. Manning et al introduced the BPP test in 1980, and since then it has been widely used as a comprehensive assessment tool for both acute and chronic fetal health and fetal congenital malformations in the antepartum period which is a method that uses an overview of 5 key indicators, namely fetal tone, fetal breathing, fetal movement, deep ventricular pocket and NST, thus making it more accurate than either viewing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time used for the biophysical profile | To compare the total time of biophysical profile assessment among pregnant women listening to music or not listening to music | Through study complete, an average 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of music | To measure music listening satisfaction in experimental groups on a scale of 1 (unsatisfied) to 5 (very satisfied). | After study complete, an average 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal biophysical profile, Music, Duration