NCT05325840

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

November 30, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

January 31, 2022

Last Update Submit

September 8, 2023

Conditions

Keywords

musicpregnancynonstrest testfetalhealth

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the Effect of Music Played During the Non-Stress Test on Fetal Health, Anxiety Level of the Pregnant and Blood Pressure

    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

Study Arms (2)

music therapy

EXPERIMENTAL

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.

Other: music terapy

standard of care

NO INTERVENTION

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.

Interventions

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.

music therapy

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswoman
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Absence of illiteracy of the pregnant woman
  • Uterine contraction in NST
  • Pregnant women who need fetal distress and urgent intervention by the physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bingöl Solhan Devlet Hastanesi

Bingöl, Solhan Bingöl, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

January 31, 2022

First Posted

April 13, 2022

Study Start

November 30, 2022

Primary Completion

April 4, 2023

Study Completion

August 29, 2023

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations