Efficacy of Music Listening to Shortening Time for Biophysical Profile (RRT)

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.

Study Overview

• Status: Completed
• Conditions: Fetal Status, Nonreassuring
• Intervention / Treatment: Diagnostic test: Trans abdominal ultrasound for assess biophysical profile

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chonburi
    • Chon Buri, Chonburi, Thailand, 20110
      • Bhanubhan Meepon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lable litter A (Study group); 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; 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.
Placebo Comparator: Lable litter B (control group); 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): December 26, 2022
• Study Completion (Actual): December 26, 2022

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Music; Duration; Fetal biophysical profile
• Additional Relevant MeSH Terms: Fetal Distress
• Other Study ID Numbers: 004/2565

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data was save inform of microsoft excel spreadsheet and SPSS file.
• IPD Sharing Time Frame: From march 2023
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No