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

NCT ID: NCT04986475

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-07-01

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.

Conditions

Anxiety; Fetal Distress; Music

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Music Therapy

Music therapy was applied during the non-stress test.

Group Type: EXPERIMENTAL

Music Therapy

Intervention Type: OTHER

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

Control

A routine non-stress test was performed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music Therapy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Yasemin ERKAL AKSOY

Lecturer Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Konya City Hospital

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 16565991 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20608798 (View on PubMed)

Other Identifiers

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Identifier Type: -

Identifier Source: org_study_id