Clinical trial NCT06199622: The Effect of Music on Pregnant Women With Gestational Hypertension
Official title: The Effect of Music on Anxiety Levels, Blood Pressure, Fetal Heart Rate and Maternal-Fetal Attachment in Pregnant Women With Gestational Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Hypertension
Music
Blood Pressure
Anxiety
Maternal-Fetal Relations
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled intervention trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: vital signs
timeFrame: 6 months
measure: anxiety
timeFrame: 6 months
measure: maternal fetal attachment
timeFrame: 6 months
measure: Fetal heart rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Faculty of Nursing
Study officials:
affiliation: Sağlık Bilimleri University
name: Büşra Güngör
role: PRINCIPAL_INVESTIGATOR
affiliation: Sağlık Bilimleri University
name: Gülten Güvenç
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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/
citation: 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.
citation: Doğan, A., Akın, B., & Tanyer, D. Gebelik Döneminde Uygulanan Müzik Girişimlerinin Maternal ve Fetal Sağlığa Etkisi: Sistematik Derleme Protokolü
citation: 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.).
citation: 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
citation: 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.
citation: 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