Efficacy of Music Listening to Shortening Time for Biophysical Profile

Not Applicable

Completed

• Conditions: Fetal Status, Nonreassuring
• Interventions: Diagnostic Test: Trans abdominal ultrasound for assess biophysical profile

• Registration Number: NCT05729750
• Lead Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

Brief Summary

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

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 Timeline

• Study Start: 2022-02-01
• Status Verified: 2022-12
• Primary Completion: 2022-12-26
• Study Completion: 2022-12-26
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-02-06
• Last Update Submitted: 2023-02-06
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Lable litter B (control group)	Trans abdominal ultrasound for assess biophysical profile	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.
Lable litter A (Study group)	Trans abdominal ultrasound for assess biophysical profile	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.

Primary Outcome Measures

Name	Time	Method
Total time used for the biophysical profile	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 Outcome Measures

Name	Time	Method
Satisfaction of music	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).

Trial Locations

Locations (1)

Bhanubhan Meepon; 🇹🇭 Chon Buri, Chonburi, Thailand