Effect of Music and Warm Foot Bath Therapy on Pregnancy-Related Anxiety, Blood Pressure and Quality of Life

Kırklareli University

Status: Enrolling

Conditions: Primigravida Women; Blood Pressure Monitoring; Quality of Life; Anxiety; Music Therapy

Treatments: Other: warm water foot bath therapy; Other: Music Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07064733

Trakya University

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 4 patient groups

music therapy group

Experimental group

Description:

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.

Treatment:

Other: Music Therapy

Warm water foot bath therapy group

Experimental group

Description:

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.

Treatment:

Other: warm water foot bath therapy

Music therapy and foot bath group (Combine Group)

Experimental group

Description:

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.

Treatment:

Other: Music Therapy

Other: warm water foot bath therapy

Control Group

No Intervention group

Description:

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.