Effect of Music and Warm Foot Bath Therapy on Pregnancy-Related Anxiety, Blood Pressure and Quality of Life
NCT ID: NCT07064733
Last Updated: 2025-07-15
Study Results
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Basic Information
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RECRUITING
NA
144 participants
INTERVENTIONAL
2025-06-06
2026-04-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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music therapy group
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.
Music Therapy
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.
Warm water foot bath therapy group
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.
warm water foot bath therapy
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.
Music therapy and foot bath group (Combine Group)
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.
Music Therapy
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.
warm water foot bath therapy
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.
Control Group
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.
No interventions assigned to this group
Interventions
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Music Therapy
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.
warm water foot bath therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
39 Years
FEMALE
Yes
Sponsors
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Kırklareli University
OTHER
Responsible Party
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Nermin Kayar
lecturer
Locations
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Trakya University
Edirne, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Soylu N, Bulbul T, Muderris II. The effect of music on fetal well-being and anxiety levels and vital signs of pregnant women during non-stress test: Turkey sample. Health Care Women Int. 2022 May;43(5):499-517. doi: 10.1080/07399332.2021.1973010. Epub 2021 Sep 14.
E Aksoy Y, D Yilmaz S, Kilic S. The effect of music therapy on non-stress test results and anxiety levels in high-risk pregnant women: A randomized controlled trial. Int J Nurs Pract. 2024 Dec;30(6):e13281. doi: 10.1111/ijn.13281. Epub 2024 Jun 20.
Estrella-Juarez F, Requena-Mullor M, Garcia-Gonzalez J, Lopez-Villen A, Alarcon-Rodriguez R. Effect of Virtual Reality and Music Therapy on the Physiologic Parameters of Pregnant Women and Fetuses and on Anxiety Levels: A Randomized Controlled Trial. J Midwifery Womens Health. 2023 Jan;68(1):35-43. doi: 10.1111/jmwh.13413. Epub 2022 Nov 16.
Other Identifiers
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Trakya University
Identifier Type: -
Identifier Source: org_study_id
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