Fetal Status, NonreassuringRRTNCT05729750
Efficacy of Music Listening to Shortening Time for Biophysical Profile
A study testing Trans abdominal ultrasound for assess biophysical profile in people with Fetal Status, Nonreassuring, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Status, Nonreassuring
- What is being tested?
- Trans abdominal ultrasound for assess biophysical profile
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2022to 26 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fetal Status, Nonreassuring
- Being tested
- Trans abdominal ultrasound for assess biophysical profile
- Keywords
- Fetal biophysical profile, Music, Duration
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans abdominal ultrasound for assess biophysical profileDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Lable litter A (Study group) | Experimental | 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. Receives: Diagnostic Test: Trans abdominal ultrasound for assess biophysical profile |
| Lable litter B (control group) | Placebo comparator | 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. Receives: Diagnostic Test: Trans abdominal ultrasound for assess biophysical profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study complete, an average 30 minutes
Secondary outcomes (1)
Satisfaction of music
To measure music listening satisfaction in experimental groups on a scale of 1 (unsatisfied) to 5 (very satisfied).
Measured: After study complete, an average 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Feb 2022
- Primary completion26 Dec 2022
- Study completion26 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Status, NonreassuringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729750
- Sponsor's protocol ID
- 004/2565
- Acronym
- RRT
- Status last verified
- Dec 2022
- First submitted
- 4 Jan 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data was save inform of microsoft excel spreadsheet and SPSS file.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Music Listening to Shortening Time for Biophysical Profile
- ClinicalTrials.gov ID
- NCT05729750
- Acronym / sponsor ID
- RRT / 004/2565
- Conditions
- Fetal Status, Nonreassuring
- Keywords
- Fetal biophysical profile, Music, Duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 26 Dec 2022 (actual)
- Study completion
- 26 Dec 2022 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lable litter A (Study group) | Experimental | Diagnostic Test: Trans abdominal ultrasound for assess biophysical profileThe 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. |
| Lable litter B (control group) | Placebo comparator | Diagnostic Test: Trans abdominal ultrasound for assess biophysical profileThe 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans abdominal ultrasound for assess biophysical profileThe 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. | Diagnostic test | Lable litter A (Study group), Lable litter B (control group) |
Primary outcome
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
1 secondary outcome
Satisfaction of music
Time frame: After study complete, an average 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Yes. Data was save inform of microsoft excel spreadsheet and SPSS file.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans abdominal ultrasound for assess biophysical profile in people with Fetal Status, Nonreassuring, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total time used for the biophysical profile (time frame: Through study complete, an average 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.