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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Kırklareli University
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Change in State Anxiety Score
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
This study is open-label. Due to the nature of the interventions-music therapy and warm foot bath-it is not possible to blind participants or investigators. All participants and study staff are aware of the assigned intervention groups.
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Change in State Anxiety Score
Time Frame: 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
Time Frame: 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
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nermin Kayar
lecturer
Kırklareli University