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NCT Number: NCT06199622

The Effect of Music on Pregnant Women With Gestational Hypertension

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music

Other

20 minutes of classical Turkish musicor classical western music

Primary outcomes

  1. vital signs

    Time frame: 6 months

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

  2. anxiety

    Time frame: 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.

  3. maternal fetal attachment

    Time frame: 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.

  4. Fetal heart rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 10, 2024
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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