Non Stress Test and Music Performance

Sponsor

Ataturk University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05325840

Collaborator

(none)

139

Enrollment

Location

Arms

4.7

Anticipated Duration (Months)

29.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Health Pregnancy Related	Other: music terapy	N/A

Detailed Description

expected

Study Design

Study Type:

Interventional

Anticipated Enrollment :

139 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 5, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Nov 25, 2022

Arms and Interventions

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.	Other: music terapy 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.

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.

Other: music terapy

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bingöl Solhan Devlet Hastanesi	Bingöl	Solhan Bingöl	Turkey

Sponsors and Collaborators

Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sibel ÖZTÜRK, Asst. Prof., Ataturk University

ClinicalTrials.gov Identifier:

NCT05325840

Other Study ID Numbers:

Ataturk University SÖZTÜRK0002

First Posted:

Apr 13, 2022

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sibel ÖZTÜRK, Asst. Prof., Ataturk University

Study Results

No Results Posted as of Jul 20, 2022