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

NCT04986475 | Completed

• 1 other identifier: 12345
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Fetal Distress; Music

Keywords

Anxiety; Fetal Distress; High Risk Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• State-Trait Anxiety Inventory (STAI)-Questionnaire

  up to one hour

Study Arms (2)

Music Therapy

EXPERIMENTAL

Music therapy was applied during the non-stress test.

Other: Music Therapy

Control

NO INTERVENTION

A routine non-stress test was performed.

Interventions

Music Therapy OTHER

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

Music Therapy

Eligibility Criteria

• Age: 19 Years - 42 Years
• Gender Eligibility Details: Participants are pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• weeks of pregnancy

You may not qualify if:

• having twin pregnancy
• with heart disease,
• fetal distress,
• having a fetus with anomaly,
• hereditary anemia,
• pregnant women with sexually transmitted diseases

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Konya City Hospital

Konya, 42130, Turkey (Türkiye)

Location

Related Publications (5)

• 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

  BACKGROUND

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

  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.

  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.

  PMID: 16565991 BACKGROUND

• 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.

  PMID: 20608798 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Fetal Distress

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In order to ensure randomization in the study, a random numbers table was created by dividing them into two groups based on the number determined on the site https://www.randomizer.org/. In order to prevent bias, in order to divide the women into groups according to the randomization list, the groups were written and sealed in two separate opaque envelopes as intervention (the ney sound is played during the NST procedure) and control (the routine NST procedure was applied). Double blinding was done on request.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Dr

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: August 2, 2021
• Study Start: April 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: July 1, 2021
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

TU (1)