The Effect of Music on Pregnant Women With Gestational Hypertension

Not Applicable

Completed

• Conditions: Gestational Hypertension; Blood Pressure; Maternal-Fetal Relations; Music; Anxiety
• Interventions: Other: music

• Registration Number: NCT06199622
• Lead Sponsor: Saglik Bilimleri Universitesi

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.

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-10-01
• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-29
• Status Verified: 2024-01
• Study First Posted: 2024-01-10
• Last Update Submitted: 2024-01-31
• Study Completion: 2024-02-01
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	music	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.

Primary Outcome Measures

Name	Time	Method
anxiety	6 months	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.
vital signs	6 months	Blood pressure (mm/Hg) of pregnant women will be measured with a calibrated sphygmomanometer.
maternal fetal attachment	6 months	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.
Fetal heart rate	6 months	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.

Trial Locations

Locations (1)

Faculty of Nursing; 🇹🇷 Ankara, Turkey