Back to resultsEfficacy of Music Listening to Shortening Time for Biophysical Profile (RRT)
Primary Purpose
Fetal Status, Nonreassuring
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Trans abdominal ultrasound for assess biophysical profile
Sponsored by
About this trial
This is an interventional diagnostic trial for Fetal Status, Nonreassuring focused on measuring Fetal biophysical profile, Music, Duration
Eligibility Criteria
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
Sites / Locations
- Bhanubhan Meepon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lable litter A (Study group)
Lable litter B (control group)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Satisfaction of music
To measure music listening satisfaction in experimental groups on a scale of 1 (unsatisfied) to 5 (very satisfied).
Full Information
NCT ID
NCT05729750
First Posted
January 4, 2023
Last Updated
February 6, 2023
Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
1. Study Identification
Unique Protocol Identification Number
NCT05729750
Brief Title
Efficacy of Music Listening to Shortening Time for Biophysical Profile
Acronym
RRT
Official Title
Efficacy of Music Listening to Shortening Time for Biophysical Profile
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 26, 2022 (Actual)
Study Completion Date
December 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Status, Nonreassuring
Keywords
Fetal biophysical profile, Music, Duration
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
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.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lable litter A (Study group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Lable litter B (control group)
Arm Type
Placebo Comparator
Arm Description
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 Type
Diagnostic Test
Intervention Name(s)
Trans abdominal ultrasound for assess biophysical profile
Intervention Description
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 Outcome Measure Information:
Title
Total time used for the biophysical profile
Description
To compare the total time of biophysical profile assessment among pregnant women listening to music or not listening to music
Time Frame
Through study complete, an average 30 minutes
Secondary Outcome Measure Information:
Title
Satisfaction of music
Description
To measure music listening satisfaction in experimental groups on a scale of 1 (unsatisfied) to 5 (very satisfied).
Time Frame
After study complete, an average 30 minutes
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnants woman
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Bhanubhan Meepon
City
Chon Buri
State/Province
Chonburi
ZIP/Postal Code
20110
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data was save inform of microsoft excel spreadsheet and SPSS file.
IPD Sharing Time Frame
From march 2023
IPD Sharing URL
https://1drv.ms/x/s!Aiv4SoaNlXd8k2mwfx0qeh0g1DLC
Learn more about this trial
Efficacy of Music Listening to Shortening Time for Biophysical Profile
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