- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05325840
Non Stress Test and Music Performance
Evaluation of the Effect of Music Played During the Non-Stress Test on Fetal Health, Anxiety Level of the Pregnant and Blood Pressure
Today, many methods are used in the evaluation of intrauterine fetal well-being. Non-stress test (NST) method is mostly used in the non-invasive evaluation of fetal well-being during pregnancy and labor. NST is a procedure in which fetal heart sounds are recorded and the relationship between fetal movements and fetal heart beat is monitored.3 Various methods are used to minimize the psychological effects that occur during pregnancy. Among these methods, it has been seen in the studies in the literature that music, which is a non-pharmacological method, has a positive effect on the pregnant woman and the fetus. It is easy and enjoyable to listen to music during the routine non-stress test process. However, there are not enough studies to prove the effect of music.
The aim of this study was to examine the effects of the music concert applied during the nonstress test procedure on the health of the fetus, the anxiety level of the pregnant woman and blood pressure.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Solhan Bingöl
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Bingöl, Solhan Bingöl, Turkey
- Bingöl Solhan Devlet Hastanesi
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Become literate
- Be in the 18-45 age range.
- Being at the 32nd and above gestational week
- Not carrying any risk factors during pregnancy (preeclampsia, IUGR, gestational diabetes, etc.)
- Have eaten at least two hours before the NST procedure
- No fetal defined cardiovascular disease
- The pregnant woman is open to communication and does not have mental or mental problems.
- Absence of auditory problems
Exclusion Criteria:
- Absence of illiteracy of the pregnant woman
- Uterine contraction in NST
- Pregnant women who need fetal distress and urgent intervention by the physician
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: music therapy
Experimental Group: Pre-test will be applied to pregnant women before the intervention. Since ST will be applied later, Nki will be applied to pregnant women, and their props will then be right lateral or lateral. NST registration form will be filled. After the pregnancy is given, the type of music (Classical Turkish Music, Turkish Classical Music, Lullaby) is asked according to the preferences of the pregnant women and their music is given for 20 minutes. The NST process will be implemented from start to finish. In the application, music from pregnant women will be played on MP3 players. After the NST procedure is applied, the pregnant women will have a son. |
The aim of this study was to examine the effects of the music concert applied during the nonstress test procedure on the health of the fetus, the anxiety level of the pregnant woman and blood pressure.
|
|
No Intervention: standard of care
Control group: First of all, Personal Information Form, State Anxiety Scale and blood pressure measurement will be made to the pregnant women in the control group. In order to perform the NST procedure, the pregnant women will be given the left side or right side position to fix the probes. NST registration form will be filled. 20 minutes after positioning the pregnant women. During the routine NST procedure will be applied and no intervention will be made. After the NST procedure is completed, the State Anxiety Scale and blood pressure measurement will be repeated as the last test of the pregnant women. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the Effect of Music Played During the Non-Stress Test on Fetal Health, Anxiety Level of the Pregnant and Blood Pressure
Time Frame: Day 1
|
The research is an experimentally planned randomized controlled trial.The sample of the study consists of pregnant women (69 experimental group, 68 control group) between 32nd and 41st weeks.
The pregnant women were evaluated with the state anxiety scale.
The scale consists of 20 items in total.
Scoring is calculated by subtracting the total weighted score for the reverse statements from the total weighted score for the direct statements.
A predetermined invariant value is added to this obtained number.This value is 50 for the state anxiety scale.
The most recent value is the individual's anxiety score.
As the score obtained from the scale increases, it indicates that the level of anxiety increases.
0-19 point no anxiety, 20-39 points mild anxiety, 40-59 points moderate anxiety, 60-79 points severe anxiety, 80 points severe anxiety.
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Ataturk University SÖZTÜRK0002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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