The Effect of Music on Pregnant Women With Gestational Hypertension

NCT ID: NCT06199622

Last Updated: 2024-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study, the effect of music on arterial blood pressure, anxiety level, fetal heart rate and maternal-fetal attachment in pregnant women with gestational hypertension will be studied and it will be conducted as a randomized controlled intervention study to examine the relationships with each other. The sample group will consist of 90 pregnant women, 45 in the intervention group and 45 in the control group. Within the scope of the study, the data will be collected using the 'Personal Information Form, State-Trait Anxiety Scale (STAI TX-I)', Maternal-Fetal Attachment Scale (MFA) created by the researcher, and the systolic blood pressure and diastolic blood pressure of each patient will be measured with a calibrated sphygmomanometer (the same sphygmomanometer was used for each patient), fetal heart rate (FHR) and fetal movements (FM) will be measured by Electronic Fetal Monitoring and Nonstress test (NST). Data will be analyzed using SPSS-25 package.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, the effect of music on arterial blood pressure, anxiety level, fetal heart rate and maternal-fetal attachment in pregnant women with gestational hypertension will be studied and it will be conducted as a randomized controlled intervention study to examine the relationships with each other. The sample group will consist of 90 pregnant women, 45 in the intervention group and 45 in the control group. Within the scope of the study, the data will be collected using the 'Personal Information Form, State-Trait Anxiety Scale (STAI TX-I)', Maternal-Fetal Attachment Scale (MFA) created by the researcher, and the systolic blood pressure and diastolic blood pressure of each patient will be measured with a calibrated sphygmomanometer (the same sphygmomanometer was used for each patient), fetal heart rate (FHR) and fetal movements (FM) will be measured by Electronic Fetal Monitoring and Nonstress test (NST). Data will be obtained by the researcher by face-to-face interviews with pregnant women. In addition, pregnant women in the intervention group will be given music once a day for 20 minutes at the beginning of the study. Pregnant women in the control group will continue their routine care. Data will be evaluated with SPSS-25 package.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Hypertension Music Blood Pressure Anxiety Maternal-Fetal Relations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a randomized controlled intervention trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

experimental group

Pregnant women in the intervention group will listen to 20 minutes of music consisting of classical western music - Beethoven moonlight sonata -, classical Turkish music - Nihavend and Buselik Maqam - for three days with a MP3 player with a good sound system and headphones.

Group Type EXPERIMENTAL

music

Intervention Type OTHER

20 minutes of classical Turkish musicor classical western music

control group

Pregnant women in the control group did not receive 20 minutes of music for three days and routine care will continue.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

music

20 minutes of classical Turkish musicor classical western music

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pregnant women hospitalized with a diagnosis of Gestational Hypertension/Mild Preeclampsia (Severe Preeclamptic Pregnant Women were not included in the study),
* Pregnancy at 28 weeks of gestation and above (since NST will be performed during follow-up),
* No hearing problems (because music will be played),
* Good level of consciousness,
* Being at least literate (for consent to be obtained),
* Being over 18 years of age (for consent to be obtained),
* No communication problems,
* A live, single, healthy fetus.
* Pregnant women who verbally and in writing agreed to participate in the study

Exclusion Criteria

* Written and verbal refusal to participate in the research,
* Illiteracy,
* Must be under 18 years of age,
* Communication problems,
* Hearing problems,
* Before the 28th week of pregnancy,
* Hospitalized for less than three days with a diagnosis of Gestational Hypertension/Preeclampsia,
* Hospitalized with a diagnosis of severe pre-eclampsia,
* Multiple pregnancies.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Büşra Güngör

master student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Büşra Güngör

Role: PRINCIPAL_INVESTIGATOR

Sağlık Bilimleri University

Gülten Güvenç

Role: PRINCIPAL_INVESTIGATOR

Sağlık Bilimleri University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Nursing

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Tsakiridis I, Giouleka S, Arvanitaki A, Mamopoulos A, Giannakoulas G, Papazisis G, Athanasiadis A, Dagklis T. Chronic hypertension in pregnancy: synthesis of influential guidelines. J Perinat Med. 2021 Apr 20;49(7):859-872. doi: 10.1515/jpm-2021-0015. Print 2021 Sep 27.

Reference Type BACKGROUND
PMID: 33872475 (View on PubMed)

Henderson JT, Vesco KK, Senger CA, Thomas RG, Redmond N. Aspirin Use to Prevent Preeclampsia and Related Morbidity and Mortality [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2021 Sep. Report No.: 21-05274-EF-1. Available from http://www.ncbi.nlm.nih.gov/books/NBK574449/

Reference Type BACKGROUND
PMID: 34644040 (View on PubMed)

Corbijn van Willenswaard K, Lynn F, McNeill J, McQueen K, Dennis CL, Lobel M, Alderdice F. Music interventions to reduce stress and anxiety in pregnancy: a systematic review and meta-analysis. BMC Psychiatry. 2017 Jul 27;17(1):271. doi: 10.1186/s12888-017-1432-x.

Reference Type BACKGROUND
PMID: 28750631 (View on PubMed)

Doğan, A., Akın, B., & Tanyer, D. Gebelik Döneminde Uygulanan Müzik Girişimlerinin Maternal ve Fetal Sağlığa Etkisi: Sistematik Derleme Protokolü

Reference Type BACKGROUND

Duman, M., Yüksekol, Ö. D., & Ozan, Y. D.(2021). Preeklampsili Gebelerde Gebelikle İlişkili Anksiyetenin Prenatal Bağlanmaya Etkisi. Jinekoloji-Obstetrik ve Neonatoloji Tıp Dergisi, 18(3), 907-915.).

Reference Type BACKGROUND

Purwati, Y. (2019). Blood Pressure Changes in Pregnant Women through Murratal and Classical Music Therapy. EAS Journal of Nursing and Midwifery, 1(4), 142-147

Reference Type BACKGROUND

Teckenberg-Jansson, P., Turunen, S., Pölkki, T., Lauri-Haikala, M. J., Lipsanen, J., Henelius, A., ... & Huotilainen, M. (2019). Effects of live music therapy on heart rate variability and self-reported stress and anxiety among hospitalized pregnant women: A randomized controlled trial. Nordic Journal of Music Therapy, 28(1), 7-26.

Reference Type BACKGROUND

Yüksekol, Ö. D., & Başer, M. (2020). The effect of music on arterial blood pressure and anxiety levels in pregnant women hospitalized due to mild preeclampsia: A pilot randomized controlled trial. European Journal of Integrative Medicine, 35, 101093

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SBU-BGUNGOR-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Music Therapy and High-risk Pregnancy
NCT06279559 RECRUITING NA
FETAL MOVEMENT COUNTING
NCT05361265 COMPLETED NA