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

Primary Purpose

Anxiety, Fetal Distress, Music

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Anxiety, Fetal Distress, High Risk Pregnancy

Eligibility Criteria

19 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Konya City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music Therapy

Control

Arm Description

Music therapy was applied during the non-stress test.

A routine non-stress test was performed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 8, 2021
Last Updated
April 10, 2023
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT04986475
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Fetal Distress, Music
Keywords
Anxiety, Fetal Distress, High Risk Pregnancy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy
Arm Type
Experimental
Arm Description
Music therapy was applied during the non-stress test.
Arm Title
Control
Arm Type
No Intervention
Arm Description
A routine non-stress test was performed.
Intervention Type
Other
Intervention Name(s)
Music Therapy
Intervention Description
Music therapy was performed by listening to the ney sound during the non-stress test procedure.
Primary Outcome Measure Information:
Title
Non stress test evaluation form
Description
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.
Time Frame
up to one hour
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI)-Questionnaire
Description
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.
Time Frame
up to one hour

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants are pregnant women.
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Konya City Hospital
City
Konya
ZIP/Postal Code
42130
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
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
Results Reference
background
Citation
Aluş Tokat M. During Pregnancy and Birth of Electronic Fetal Follow. İstanbul: Deomed Press; 2013. 23-62 p.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
16565991
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.
Results Reference
background
PubMed Identifier
20608798
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.
Results Reference
background

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

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