An interventional study of Music Therapy and warm water foot bath therapy in Primigravida Women, Music Therapy and Blood Pressure Monitoring, sponsored by Kırklareli University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by Kırklareli University · Not applicable, Interventional, and Supportive care
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.
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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 144 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Kırklareli University is the lead sponsor of 49 studies on the registry; 14 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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18-39 years of age,
Exclusion Criteria:
At 26 weeks and above, low-risk primigravida pregnant women will be informed about the purpose of the study and voluntary participation will be ensured. Those who score 20 and above on both subscales of the State-Trait Anxiety Inventory will be included in the study. Participants will be educated about music therapy and blood pressure measurement at the first home visit and brochures will be provided. Contact information will be obtained and the EQ-5D General Quality of Life Scale will be applied. Handpan music rhythm with a volume level not exceeding 60 dB will be played for 30 minutes in the morning and evening, 3 days a week when the pregnant woman is available. Blood pressure measurements will be made before and after the session (0, 30, 60 minutes), and the scales will be reapplied by telephone at the end of the week. In pregnant women hospitalized in the ward, the same protocol will be applied by the coordinator during hospitalization.
Other: Music Therapy
At 26 weeks and above, low-risk primigravida pregnant women hospitalized in outpatient clinic or obstetrics and gynecology service will be explained the purpose of the study and voluntary participation will be ensured. Those who score 20 and above on both subscales of the State-Trait Anxiety Inventory will be included in the study. During the first home visit, warm water foot bath (37-40°C, 10-15 min), education about the application and blood pressure measurement will be given and a brochure will be presented. Contact information will be obtained and the EQ-5D Quality of Life Scale will be applied. Foot baths will be applied 3 days a week, morning and evening, when the pregnant woman is available. Blood pressure measurements will be made before and after the session (0, 30, 60 minutes). At the end of the weeks, the scales will be repeated by telephone. For pregnant women hospitalized in the ward, the same protocol will be applied during hospitalization.
Other: warm water foot bath therapy
At 26 weeks and above, low-risk primigravida pregnant women will be informed about the purpose of the study and voluntary participation will be ensured. Those who score 20 and above on both subscales of the State-Trait Anxiety Inventory will be included. During the first home visit, a brochure will be given about music therapy and warm water foot bath (37-40°C, 10-15 minutes). In music therapy, a quiet, dimly lit environment, appropriate position and positive thoughts will be suggested. Contact information of the pregnant woman will be obtained and EQ-5D Quality of Life Scale will be applied. A warm water foot bath will be taken in the morning and evening, 3 days a week, and then a handpan music recording will be played for 30 minutes at 60 dB. Blood pressure measurements will be made before and after the session (0, 30, 60 minutes). At the end of the weeks, the scales will be repeated by telephone. Pregnant women hospitalized in the ward will follow the same protocol.
Other: Music Therapy · Other: warm water foot bath therapy
At 26 weeks and above, low-risk primigravida pregnant women with outpatient follow-up or hospitalization in the obstetrics and gynecology service will be explained the purpose of the study and voluntary participation will be ensured. Pregnant women who scored 20 and above on both subscales of the State-Trait Anxiety Inventory will be included in the study. Blood pressure measurements will be made in the morning and evening on 3 days of the week, and the scales will be reapplied at the end of the first and second week. No intervention will be made to the pregnant women. At the end of the study, pregnant women in the control group will be offered optional music therapy and warm water foot baths.
The 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.
The 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.
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 14
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 14
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.
Plan to share: No — De-identified participant data, study protocols, and analysis plans will be made available upon reasonable request to qualified researchers following publication of the study results. Data sharing will comply with ethical guidelines and participant confidentiality will be strictly maintained.
Started Jun 2025 (actual). Primary completion is estimated for Dec 2025, 6 months after the start.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 6 months is below that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
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Kırklareli University