AnxietyNCT04986475
Music Therapy on High Risk Pregnant Women of Non-Stress Test
A study testing Music Therapy in people with Anxiety and Fetal Distress, run by Selcuk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 19 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Fetal Distress, Music
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- having twin pregnancy
- with heart disease,
- fetal distress,
- having a fetus with anomaly,
- hereditary anemia,
- pregnant women with sexually transmitted diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music Therapy on High Risk Pregnant Women of Non-Stress Test and Anxiety Levels
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.
Read the 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
- Being tested
- Music Therapy
- Keywords
- Anxiety, Fetal Distress, High Risk Pregnancy
- Medical subject headings
- Anxiety Disorders, Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
Music therapy was performed by listening to the ney sound during the non-stress test procedure.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | Music therapy was applied during the non-stress test. Receives: Other: Music Therapy |
| Control | No intervention | A routine non-stress test was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to one hour
Secondary outcomes (1)
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.
Measured: up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Apr 2021
- Primary completion31 May 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin ERKAL AKSOY, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986475
- Sponsor's protocol ID
- 12345
- Status last verified
- Apr 2023
- First submitted
- 8 Jul 2021
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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
Aluş Tokat M. During Pregnancy and Birth of Electronic Fetal Follow. İstanbul: Deomed Press; 2013. 23-62 p.
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.
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.
PubMed 16565991Kafali 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.
PubMed 20608798
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on High Risk Pregnant Women of Non-Stress Test and Anxiety Levels
- ClinicalTrials.gov ID
- NCT04986475
- Acronym / sponsor ID
- 12345
- Conditions
- Anxiety, Fetal Distress, Music
- Keywords
- Anxiety, Fetal Distress, High Risk Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Other: Music TherapyMusic therapy was applied during the non-stress test. |
| Control | No intervention | –A routine non-stress test was performed. |
Who may qualify
- Ages
- 19 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- having twin pregnancy
- with heart disease,
- fetal distress,
- having a fetus with anomaly,
- hereditary anemia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyMusic therapy was performed by listening to the ney sound during the non-stress test procedure. | Other | Music Therapy |
Primary outcome
Non stress test evaluation form
Time frame: up to one hour
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.
1 secondary outcome
State-Trait Anxiety Inventory (STAI)-Questionnaire
Time frame: up to one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- BackgroundŞimşek 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
- BackgroundAluş Tokat M. During Pregnancy and Birth of Electronic Fetal Follow. İstanbul: Deomed Press; 2013. 23-62 p.
- BackgroundDönmez 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: PubMed 16565991Muller 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.
- Background: PubMed 20608798Kafali 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.
- Individual participant dataSharing planned: Yes
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Anxiety and Fetal Distress, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non stress test evaluation form (time frame: up to one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04986475, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.