Music and warm foot baths to reduce pregnancy-related anxiety and improve quality of life
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
This trial will try music therapy, warm foot baths, or both in low-risk first-time pregnant women to see if they lower anxiety, affect blood pressure, and improve quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | Female |
| Sponsor | Kırklareli University Academic / other |
| Locations | 1 site (Edirne) |
| Trial ID | NCT07064733 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 144 low-risk primigravida women at 26 weeks' gestation or later and randomly assign them to one of four groups: music therapy (handpan music), warm foot bath therapy, combined therapy, or control. Interventions will be delivered over two weeks with pre- and post-intervention assessments. Outcomes include the State-Trait Anxiety Inventory (STAI TX-1 and TX-2), blood pressure measurements, and the EQ-5D quality of life scale. Participants must be 18–39, literate, own a smartphone, and have no major pregnancy complications, psychiatric disorders, or significant medical conditions.
Who should consider this trial
Good fit: Eligible patients are low-risk first-time pregnant women aged 18–39 at 26+ weeks gestation who can read, consent, use a smartphone, and have no major medical or psychiatric problems.
Not a fit: Women with high-risk pregnancies, multiple gestation, preeclampsia or other significant obstetric complications, known psychiatric disorders, hearing impairment, or major medical illnesses are excluded and unlikely to benefit from these specific interventions.
Why it matters
Potential benefit: If successful, these low-cost, non-drug interventions could reduce pregnancy-related anxiety and improve quality of life with minimal side effects.
How similar studies have performed: Previous small trials and reviews suggest music and relaxation techniques can modestly reduce prenatal anxiety, while evidence for warm foot baths is less consistent and combining both is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Edirne
- Trakya University — Edirne, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: nermin kayar
- Email: nerminkayar24@gmail.com
- Phone: +905425530518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.