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

Not Applicable

Recruiting

• Conditions: Primigravida Women; Music Therapy; Blood Pressure Monitoring; Quality of Life; Anxiety

• Registration Number: NCT07064733
• Lead Sponsor: Kırklareli University

Brief Summary

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.

Study Timeline

• Study Start: 2025-06-06
• Study First Submitted: 2025-06-25
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Primary Completion: 2025-12-30
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in State Anxiety Score	Baseline, Day 7, and Day 14	It consists of two subscales of 20 items each measuring state and trait anxiety. The State Anxiety Inventory (SAI) asks the individual to describe how he/she feels at a particular moment and under certain conditions; the Trait Anxiety Inventory (TAI) asks the individual to describe how he/she feels in general. The inventory is rated on a 4-point scale. Higher scores indicate higher levels of anxiety. In Spielberger's State and Trait Anxiety Inventory, 0-19 points are considered as No Anxiety, 20-39 points as Mild Anxiety, 40-59 points as Moderate Anxiety, 60-79 points as Severe Anxiety and 80 points as Panic.
EQ-5D General Quality of Life Scale	Baseline, Day 7, and Day 14	The scale is a short, generic instrument used to define quality of life and to assign a quantitative value to health status. It consists of a VAS scale (excellent health to death) and 5 3-choice questions (mobility, self-care, usual daily tasks, pain discomfort, anxiety demoralization). The answers to each item have 3 options: no problem, some problem and major problem. As a result, the scale identifies 243 possible different health outcomes. An index score ranging from -0.59 to 1 is calculated from the 5 dimensions of the scale. In the score function, a value of 0 indicates death, a value of 1 indicates perfect health, while negative values indicate conditions such as unconsciousness, living bedridden, etc.
blood pressure Measurement	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.	Systolic and diastolic blood pressure will be measured at rest using a standardized sphygmomanometer immediately before the intervention, and at 0, 30, and 60 minutes after the intervention sessions.

Trial Locations

Locations (1)

Trakya University; 🇹🇷 Edirne, Turkey