The Effect of Music on Pregnant Women With Gestational Hypertension

NCT06199622 | Completed

• 1 other identifier: SBU-BGUNGOR-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Hypertension; Music; Blood Pressure; Anxiety; Maternal-Fetal Relations

Outcome Measures

Primary Outcomes (4)

• vital signs

  Blood pressure (mm/Hg) of pregnant women will be measured with a calibrated sphygmomanometer.

  6 months

• 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

• 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

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

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.

Other: music

control group

NO INTERVENTION

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

Interventions

music OTHER

20 minutes of classical Turkish musicor classical western music

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Faculty of Nursing

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 33872475 BACKGROUND

• 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/

  PMID: 34644040 BACKGROUND

• 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.

  PMID: 28750631 BACKGROUND

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

  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.).

  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

  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.

  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

  BACKGROUND

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Büşra Güngör

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Gülten Güvenç

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master student

Model Details: This study is a randomized controlled intervention trial

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 10, 2024
• Study Start: April 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: February 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)