Primigravida WomenNCT07064733
Effect of Music and Warm Foot Bath Therapy on Pregnancy-Related Anxiety, Blood Pressure and Quality of Life
A study testing Music Therapy and warm water foot bath therapy in people with Primigravida Women and Music Therapy, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primigravida Women, Music Therapy, Blood Pressure Monitoring
- What is being tested?
- Music Therapy and warm water foot bath therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- - Having hearing impairment,
- Refusing to participate,
- Being illiterate,
- Having communication problems,
- Being hospitalized with severe preeclampsia,
- The newborn not surviving.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Trakya University
Edirne
nermin kayar, 05425530518, nerminkayar24@gmail.com
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Music Therapy, warm water foot bath therapy
- Keywords
- primigravida, music therapy, Warm Foot Bath, Quality of Life, blood pressure
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| music therapy group | Experimental | 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. Receives: Other: Music Therapy |
| Warm water foot bath therapy group | Experimental | 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. Receives: Other: warm water foot bath therapy |
| Music therapy and foot bath group (Combine Group) | Experimental | 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. Receives: Other: Music Therapy; Other: warm water foot bath therapy |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start6 Jun 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primigravida WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of four parallel groups: (1) music therapy only, (2) warm foot bath therapy only, (3) combined music and foot bath therapy, or (4) control group with no intervention. Each intervention group will receive their respective therapy for 2 weeks, 3 times per week. Pre- and post-intervention assessments of anxiety, blood pressure, and quality of life will be conducted. The control group will receive usual antenatal care without any intervention but will be assessed using the same outcome measures.
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermin Kayar, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064733
- Sponsor's protocol ID
- Trakya University
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 34520324E 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.
PubMed 39031663Estrella-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.
PubMed 36383473
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07064733
- Acronym / sponsor ID
- Trakya University
- Keywords
- primigravida, music therapy, Warm Foot Bath, Quality of Life, blood pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to one of four parallel groups: (1) music therapy only, (2) warm foot bath therapy only, (3) combined music and foot bath therapy, or (4) control group with no intervention. Each intervention group will receive their respective therapy for 2 weeks, 3 times per week. Pre- and post-intervention assessments of anxiety, blood pressure, and quality of life will be conducted. The control group will receive usual antenatal care without any intervention but will be assessed using the same outcome measures.
| Arm | Type | Receives |
|---|---|---|
| music therapy group | Experimental | Other: Music TherapyAt 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. |
| Warm water foot bath therapy group | Experimental | Other: warm water foot bath therapyAt 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. |
| Music therapy and foot bath group (Combine Group) | Experimental | Other: Music Therapy, Other: warm water foot bath therapyAt 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-39 years of age,
Key exclusion criteria (15 listed)
- - Having hearing impairment,
- Refusing to participate,
- Being illiterate,
- Having communication problems,
- Being hospitalized with severe preeclampsia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyThe 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. | Other | Music therapy and foot bath group (Combine Group), music therapy group |
| warm water foot bath therapyThe 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. | Other | Music therapy and foot bath group (Combine Group), Warm water foot bath therapy group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Background: PubMed 34520324Soylu 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.
- Background: PubMed 39031663E 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.
- Background: PubMed 36383473Estrella-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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy and warm water foot bath therapy in people with Primigravida Women and Music Therapy, run by Kırklareli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact nermin kayar (+905425530518, nerminkayar24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety Score (time frame: Baseline, Day 7, and Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07064733, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.