Effect of Music and Warm Foot Bath Therapy on Pregnancy-Related Anxiety, Blood Pressure and Quality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-39
SponsorKırklareli University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
- Having hearing impairment,
Refusing to participate,
Being illiterate,
Having communication problems,
Trial design
Design model
Parallel
Treatments tested in this trial
Music Therapy
Other interventionThe 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 and prevent overstimulation. Sessions will be scheduled three times per week, in the morning and evening, over a two-week period. Before each session, participants will be reminded by phone and instructed to measure their blood pressure immediately prior to and at 0, 30, and 60 minutes after the music listening. The therapy aims to create a calming environment that encourages positive thoughts and bonding with the fetus.
warm water foot bath therapy
Other interventionThe 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 a companion nearby when standing up to avoid falls. The intervention will be applied three times weekly, in the morning and evening, over a two-week period. Blood pressure measurements will be taken immediately before and at 0, 30, and 60 minutes after each session.
Treatment groups
144 Participants
are divided into 4 treatment groupsGroup A: music therapy groupExperimental treatment 1 intervention
Group B: Warm water foot bath therapy groupExperimental treatment 1 intervention
Group C: Music therapy and foot bath group (Combine Group)Experimental treatment 2 interventions
Group D: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in State Anxiety Score
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.
Time frame
Baseline, Day 7, and Day 142
EQ-5D General Quality of Life Scale
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.
Time frame
Baseline, Day 7, and Day 143
blood pressure Measurement
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov