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Completed

NCT Number: NCT05729750

Efficacy of Music Listening to Shortening Time for Biophysical Profile

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.

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Key information

Conditions

Fetal Status, Nonreassuring Fetal Distress Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bhanubhan Meepon

Chon Buri, Changwat Chon Buri, 20110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trans abdominal ultrasound for assess biophysical profile

Diagnostic Test

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.

Primary outcomes

  1. Total time used for the biophysical profile

    Time frame: Through study complete, an average 30 minutes

    To compare the total time of biophysical profile assessment among pregnant women listening to music or not listening to music

Secondary outcomes

  1. Satisfaction of music

    Time frame: After study complete, an average 30 minutes

    To measure music listening satisfaction in experimental groups on a scale of 1 (unsatisfied) to 5 (very satisfied).

Sponsors and collaborators

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Other

Registry information

Acronym: RRT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2023
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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