The effect of music on fetal well-being and anxiety levels and vital signs of pregnant women during non-stress test: Turkey sample.
Nurseli Soylu, Tülay Bülbül, İptisam İpek Müderris
https://pubmed.ncbi.nlm.nih.gov/34520324Actively Recruiting
Phase Not Applicable
Age: 18Years - 39Years
FEMALE
Healthy Volunteers
ID07064733
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
Led by Kırklareli University · Updated on 2025-07-15
144
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how music therapy and warm foot bath therapy affect pregnancy-related anxiety, blood pressure, and quality of life in low-risk first-time pregnant women who are 26 weeks gestation or more. The study involves 144 participants who will be randomly assigned to one of four groups: music therapy, warm foot bath therapy, combined therapy, or a control group without intervention. The goal is to understand if these non-drug approaches can help improve well-being during pregnancy. Participants in the music therapy group will listen to 30-minute sessions of handpan music at home in a quiet, dim environment three times a week, both morning and evening, with the sound kept below 60 decibels. The warm foot bath group will soak their feet in 37-40°C water for 10-15 minutes on the same schedule. The combined group will receive both interventions. Blood pressure will be measured before and after each session. The control group will have no intervention but will be offered the therapies after the study ends. Throughout the two-week study, participants will be monitored closely. Anxiety and quality of life will be assessed at the start, day 7, and day 14 using the State-Trait Anxiety Inventory and EQ-5D scales. Blood pressure will be checked multiple times during intervention days, before and after sessions. Participants will receive education, brochures, and contact support. Those hospitalized will follow the same protocols under coordinator supervision. The study aims to capture changes in anxiety, blood pressure, and quality of life over time.
CONDITIONS
Brief Title
Effect of Music and Warm Foot Bath Therapy on Pregnancy-Related Anxiety, Blood Pressure and Quality of Life
Who Can Participate
Age: 18Years - 39Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Between 18 and 39 years of age
- Literate and able to make an informed decision, communicate verbally, and sign consent
- Pregnant with a single, live fetus
- Owns a smartphone
- Low-risk first-time pregnancy with gestational age of 26 weeks or more
You will not qualify if you...
- Hearing impairment
- Refusal to participate
- Illiteracy
- Communication problems
- Hospitalized with severe preeclampsia
- Newborn not surviving
- Antepartum hemorrhage
- Preeclampsia
- Gestational hypertension
- Cervical insufficiency
- Pregnancy-related complications like congenital fetal anomalies or intrauterine growth restriction diagnosed before 28 weeks
- Multiple pregnancies
- Known psychiatric disorders such as anxiety or depression
- Medical problems including endocrine disorders like gestational diabetes or thyroid dysfunction
- Use of assisted reproductive techniques like IVF or embryo transfer
- Being at risk of preterm birth
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 2 weeks
Participants receive assigned non-pharmacological interventions including music therapy, warm foot bath therapy, both combined, or no intervention. Interventions are designed to reduce anxiety, regulate blood pressure, and improve quality of life during pregnancy.
Sessions 3 times per week in the morning and evening; blood pressure measured before and at 0, 30, and 60 minutes after each session
Follow-up
Duration - Up to 2 weeks
Participants complete anxiety and quality of life assessments by telephone at the end of the first and second week.
2 telephone follow-up assessments
Trial Site Locations
Total: 1 location
1
Trakya University
Edirne, Turkey (Türkiye)
Actively Recruiting
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Research Team
N
nermin kayar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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Published Research Related To This Trial
The effect of music therapy on non-stress test results and anxiety levels in high-risk pregnant women: A randomized controlled trial.
Yasemin E Aksoy, Sema D Yilmaz, Süreyya Kiliç
https://pubmed.ncbi.nlm.nih.gov/39031663Effect of Virtual Reality and Music Therapy on the Physiologic Parameters of Pregnant Women and Fetuses and on Anxiety Levels: A Randomized Controlled Trial.
Fatima Estrella-Juarez, Mar Requena-Mullor, Jessica Garcia-Gonzalez...
https://pubmed.ncbi.nlm.nih.gov/36383473