The Effect of Music on Pregnant Women With Gestational Hypertension

Anxiety Clinical Trial

Official title:

The Effect of Music on Anxiety Levels, Blood Pressure, Fetal Heart Rate and Maternal-Fetal Attachment in Pregnant Women With Gestational Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06199622
• Other study ID #: SBU-BGUNGOR-001
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2024
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Blood Pressure
• Gestational Hypertension
• Hypertension
• Hypertension, Pregnancy-Induced
• Maternal-Fetal Relations
• Music

Intervention

Other:
• music
20 minutes of classical Turkish musicor classical western music

Locations

Country	Name	City	State
Turkey	Faculty of Nursing	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View Citation

Dogan, A., Akin, B., & Tanyer, D. Gebelik Döneminde Uygulanan Müzik Girisimlerinin Maternal ve Fetal Sagliga Etkisi: Sistematik Derleme Protokolü

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

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/ — View 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

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.

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. — View Citation

Yüksekol, Ö. D., & Baser, 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vital signs	Blood pressure (mm/Hg) of pregnant women will be measured with a calibrated sphygmomanometer.	6 months
Primary	anxiety	Anxiety will be measured with State-Trait Anxiety Inventory (STAI TX-I) before and after the intervention. The scale consists of 20 items on a 4-point Likert scale ((1) not at all, (2) a little, (3) a lot, (4) completely). The total score value obtained can vary between 20 and 80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety.	6 months
Primary	maternal fetal attachment	Changes in mother-infant attachment will be measured with the Maternal-Fetal Attachment Scale (MFA) before and after the intervention. Responses are scored from 1-5, with 5 being the most positive statement. The higher the score, the higher the attachment.	6 months
Primary	Fetal heart rate	Nonstress test (NST) will be performed with Electronic Fetal Monitoring for an average of 20 minutes and fetal heart rate (beats per minute) will be recorded.	6 months