Effect of Music and Warm Foot Bath Therapy on Pregnancy-Related Anxiety, Blood Pressure and Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Music Therapy, warm water foot bath therapy.
- Who it may be relevant to
- Registry conditions: Primigravida Women, Music Therapy, Blood Pressure Monitoring, Quality of Life. Basic parameters: 18 years — 39 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Other 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 - Other 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
Primary outcome measures
- Change in State Anxiety Score [Time frame: Baseline, Day 7, and Day 14]
- EQ-5D General Quality of Life Scale [Time frame: Baseline, Day 7, and Day 14]
- blood pressure Measurement [Time frame: 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.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- \- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Trakya University — Edirne
Publications
- 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
Identifiers
NCT: NCT07064733 · Trakya University