Clinical trial NCT04986475: Music Therapy on High Risk Pregnant Women of Non-Stress Test
Official title: The Effect of Music Therapy on High Risk Pregnant Women of Non-Stress Test and Anxiety Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Fetal Distress
Music
Keywords: Anxiety
Fetal Distress
High Risk Pregnancy
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 116
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Non stress test evaluation form
timeFrame: up to one hour
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI)-Questionnaire
timeFrame: up to one hour
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
Study officials:
References:
citation: Şimşek Küçükkelepçe D, Timur Taşhan 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
citation: Aluş Tokat M. During Pregnancy and Birth of Electronic Fetal Follow. İstanbul: Deomed Press; 2013. 23-62 p.
citation: Dönmez S, Dağ H, Kazandı M. The Determination of Pregnant Women's Anxiety and Depression Risk Levels Before Amniocentesis. Acıbadem Üniversitesi Sağlık Bilimleri Dergisi. 2012;3(4):255-61.
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.
citation: 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.