Efficacy of Music Listening to Shortening Time for Biophysical Profile
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Total time used for the biophysical profile
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Diagnostic
- Masking
- Single (Investigator)
Masking Description
All participants whatever study or control gruops will get the headphone which may turn on the music in study gruop only that mean investigator will not known who are in listening to music.
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Trans abdominal ultrasound for assess biophysical profile (Diagnostic Test)
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.
Intervention: Trans abdominal ultrasound for assess biophysical profile (Diagnostic Test)
Outcomes
Primary Outcomes
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
- Satisfaction of music(After study complete, an average 30 minutes)