Music Therapy on High Risk Pregnant Women of Non-Stress Test

Anxiety Clinical Trial

Official title:

The Effect of Music Therapy on High Risk Pregnant Women of Non-Stress Test and Anxiety Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04986475
• Other study ID #: 12345
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: April 2023
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Non-stress testing (NST) is one of the most commonly used methods to assess fetal health in the prenatal period because it is an easily interpreted, non-invasive, painless, and short-term diagnostic method. Although NST is a non-invasive and painless diagnostic method, pregnant women may feel anxiety during the procedure.

It is supported by studies that listening to music causes relaxation and reducing anxiety. Therefore, the use of music as a non-pharmacological practice will increase the quality of care of individuals. There are many studies suggesting that music reduces anxiety in low-risk pregnancies during NST application. Different instruments such as ney, rebab, kopuz, dombra are used in Turkish music. In particular, ney has come to the fore in music therapy. The ney, which has different types in history, is an instrument that is closest to the human voice. In a compilation about the music used in music therapy in Turkey, it was stated that there are many social and health studies made with the sound of ney. Determining the effect of music on NST and anxiety in high-risk pregnant women will contribute to the literature.

Description:

Non-stress testing (NST) is one of the most commonly used methods to assess fetal health in the prenatal period because it is an easily interpreted, non-invasive, painless, and short-term diagnostic method. Although NST is a non-invasive and painless diagnostic method, pregnant women may feel anxiety during the procedure.

It is supported by studies that listening to music causes relaxation and reducing anxiety. Therefore, the use of music as a non-pharmacological practice will increase the quality of care of individuals. There are many studies suggesting that music reduces anxiety in low-risk pregnancies during NST application. Different instruments such as ney, rebab, kopuz, dombra are used in Turkish music. In particular, ney has come to the fore in music therapy. The ney, which has different types in history, is an instrument that is closest to the human voice. In a compilation about the music used in music therapy in Turkey, it was stated that there are many social and health studies made with the sound of ney. Determining the effect of music on NST and anxiety in high-risk pregnant women will contribute to the literature.

The aim of this study is to determine the effect of music therapy on NST and anxiety levels in high-risk pregnant women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 1, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 42 Years

Eligibility

Inclusion Criteria:

• over 18 years old

• Those diagnosed with high-risk pregnancy by a physician (pregnancy-induced hypertension, preeclampsia, eclampsia, gestational diabetes, premature rupture of membranes, pregnancy large or small for gestational age, intrauterine growth retardation, pain/contraction, oligohydramnios, premature birth threat, maternal age 35 age and above, maternal body mass index over 30 (obesity))

• Speaking and understanding Turkish

• Pregnant women with a single fetus

• 32-41 weeks of pregnancy

Exclusion Criteria:

• having twin pregnancy

• with heart disease,

• fetal distress,

• having a fetus with anomaly,

• hereditary anemia,

• pregnant women with sexually transmitted diseases

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Fetal Distress
• Music

Intervention

Other:
• Music Therapy
Music therapy was performed by listening to the ney sound during the non-stress test procedure.

Locations

Country	Name	City	State
Turkey	Konya City Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Alus Tokat M. During Pregnancy and Birth of Electronic Fetal Follow. Istanbul: Deomed Press; 2013. 23-62 p.

Dönmez S, Dag H, Kazandi M. The Determination of Pregnant Women's Anxiety and Depression Risk Levels Before Amniocentesis. Acibadem Üniversitesi Saglik Bilimleri Dergisi. 2012;3(4):255-61.

Kafali H, Derbent A, Keskin E, Simavli S, Gozdemir E. Effect of maternal anxiety and music on fetal movements and fetal heart rate patterns. J Matern Fetal Neonatal Med. 2011 Mar;24(3):461-4. doi: 10.3109/14767058.2010.501122. Epub 2010 Jul 7. — View Citation

Muller MA, Bleker OP, Bonsel GJ, Bilardo CM. Nuchal translucency screening and anxiety levels in pregnancy and puerperium. Ultrasound Obstet Gynecol. 2006 Apr;27(4):357-61. doi: 10.1002/uog.2761. — View Citation

Simsek Küçükkelepçe D, Timur Tashan S. The effect of music on the results of a non-stress test: A non-randomized controlled clinical trial. European Journal of Integrative Medicine [Internet]. 2018 Feb;18:8-12. Available from: https://linkinghub.elsevier.com/retrieve/pii/S1876382018300106

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non stress test evaluation form	It was created by researchers in order to record and evaluate the findings related to the NST procedure. In the NST evaluation form, fetal heart rate and variability, which were followed for at least 20 minutes, number of accelerations, decelerations and fetal movements, test result (reactive or nonreactive) were included.	up to one hour
Secondary	State-Trait Anxiety Inventory (STAI)-Questionnaire	STAI was used to measure the anxiety level of pregnant women. It was developed by Spielberger et al. (Spielberger et al., 1970) and Öner and Le Compte conducted a Turkish validity and reliability study of the scale (Öner & LeCompte, 1983). In the scale, individuals are provided to express their feelings with 40 expressions. With the state anxiety scale, it is possible to determine how the individual feels at the moment and in the conditions, and with the trait anxiety scale, how he feels outside of the current situation and conditions. The scale is a 4-point Likert type.The last score obtained shows the anxiety level of the individual. High scores from the scale indicate an increased level of anxiety, low scores indicate a decrease.	up to one hour