NCT07064733

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Kırklareli University · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Primigravida Women
• Music Therapy
• Blood Pressure Monitoring
• Quality of Life
• Anxiety

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2025-06-06
• Primary completion: 2025-12-30
• Completion: 2026-04-01
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: Turkey (Türkiye)