Effect of Music and Warm Foot Bath Therapy on Pregnancy-Related Anxiety, Blood Pressure and Quality of Life

Официальное название

A Randomized Controlled Trial on the Effect of Music Therapy and Warm Foot Bath Therapy on Anxiety, Blood Pressure, and Quality of Life in Low-Risk Primigravida Pregnant Women

Обзор

Study Title: The Effects of Music Therapy and Warm Foot Bath on Pregnancy-Related Stress, Blood Pressure, and Quality of Life in Low-Risk Primigravida Women Brief Summary: This randomized controlled trial investigates the impact of music therapy and warm foot bath therapy on pregnancy-related anxiety, blood pressure levels, and quality of life in low-risk primigravida pregnant women. Participants will be randomly assigned into four groups: music therapy, warm foot bath therapy, combined therapy, and control group. The interventions will be carried out for 2 weeks with pre- and post-assessments of anxiety and quality of life.

Подробное описание

Pregnancy is a period of significant physiological and psychological changes that can increase anxiety levels in women. This study aims to assess whether non-pharmacological interventions such as music therapy (handpan music) and warm foot baths can reduce anxiety, regulate blood pressure, and improve the quality of life in low-risk primigravida pregnant women at 26 weeks of gestation and above. A total of 144 participants will be randomly assigned to one of four groups and followed for two weeks. Data collection tools will include the State-Trait Anxiety Inventory (STAI TX-1 and TX-2), blood pressure monitoring forms, and EQ-5D quality of life scale.

Вмешательства

• Другое Music Therapy
  The music therapy intervention consists of listening sessions using specially recorded handpan music, designed to promote relaxation and reduce anxiety in pregnant women. The handpan is a melodic percussion instrument known for its soothing and harmonic sound qualities. Participants will listen to a 30-minute handpan music recording at home, in a quiet and dimly lit room, while resting in a semi-fowler or left lateral position. The sound volume will be kept below 60 decibels to ensure comfort a
• Другое warm water foot bath therapy
  The warm water foot bath therapy involves soaking the participant's feet in water heated to 37-40°C for 10-15 minutes per session. This therapy is designed to promote relaxation, improve peripheral circulation, and reduce anxiety symptoms. Participants will perform the foot bath in a safe and comfortable setting, ensuring water temperature is monitored with a thermometer before each session. After soaking, feet should be thoroughly dried to prevent slipping, and participants are advised to have

Первичные конечные точки

• Change in State Anxiety Score [Срок оценки: Baseline, Day 7, and Day 14]
• EQ-5D General Quality of Life Scale [Срок оценки: Baseline, Day 7, and Day 14]
• blood pressure Measurement [Срок оценки: Days 1, 3, 5, 8, 10, and 12; with measurements at pre-, immediate post-, 30-min post-, and 60-min post-intervention, morning and evening sessions.]

Критерии участия

Критерии включения

• 18-39 years of age,

• Literate; able to make an informed decision to participate, communicate verbally, and sign a consent form
• Pregnant with a single, live fetus
• Have a smartphone
• Low-risk primigravida pregnant with a gestational age of 26 weeks or more

Критерии исключения

• \- Having hearing impairment,
• Refusing to participate,
• Being illiterate,
• Having communication problems,
• Being hospitalized with severe preeclampsia,
• The newborn not surviving.
• Antepartum hemorrhage
• Preeclampsia,
• Gestational hypertension,
• Cervical insufficiency,
• Having pregnancy-related complications such as congenital fetal anomalies and intrauterine growth restriction diagnosed before 28 weeks of gestation or having multiple pregnancies;
• Having psychiatric disorders (known anxiety or depression, other illnesses),
• Having medical problems such as endocrine disorders (gestational diabetes mellitus, thyroid dysfunction, etc.);
• Having assisted reproductive techniques (ART) such as in vitro fertilization, embryo transfer, or
• Pregnant women at risk of preterm birth will not be included in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Trakya University — Edirne

Публикации

• Soylu N, Bulbul T, Muderris II. The effect of music on fetal well-being and anxiety levels and vital signs of pregnant women during non-stress test: Turkey sample. Health Care Women Int. 2022 May;43(5):499-517. doi: 10.1080/07399332.2021.1973010. Epub 2021 Sep 14. PMID 34520324
• E Aksoy Y, D Yilmaz S, Kilic S. The effect of music therapy on non-stress test results and anxiety levels in high-risk pregnant women: A randomized controlled trial. Int J Nurs Pract. 2024 Dec;30(6):e13281. doi: 10.1111/ijn.13281. Epub 2024 Jun 20. PMID 39031663
• Estrella-Juarez F, Requena-Mullor M, Garcia-Gonzalez J, Lopez-Villen A, Alarcon-Rodriguez R. Effect of Virtual Reality and Music Therapy on the Physiologic Parameters of Pregnant Women and Fetuses and on Anxiety Levels: A Randomized Controlled Trial. J Midwifery Womens Health. 2023 Jan;68(1):35-43. doi: 10.1111/jmwh.13413. Epub 2022 Nov 16. PMID 36383473

Идентификаторы

NCT: NCT07064733 · Trakya University

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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