NCT06724328

Maternal Heartbeat Sounds and Therapeutic Touch on Heart Rate,Comfort and Behavior in Newborns

Maternal Heartbeat Sounds and Therapeutic Touch

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Dokuz Eylul University · Academic / Other
• Sex: All
• Age: 32 Weeks – 40 Weeks
• Healthy volunteers: Not accepted

Summary

This randomized controlled study aims to evaluate the effects of maternal heartbeat sounds and gentle human touch (GHT), a form of therapeutic touch, on heart rate, comfort, and behavioral scores in neonates born between 32 and 40 weeks and admitted to the neonatal intensive care unit (NICU).

Detailed description

This parallel, randomized controlled trial will be conducted in the Neonatal Intensive Care Unit of a regional hospital. The sample will consist of 120 neonates with gestational ages of 32 to ≤40 weeks and randomly assigned to four groups (maternal heart sound, therapeutic touch, maternal heart sound + therapeutic touch, and control group). The data of the study are the Newborn Information Form, the Anderson Behavioral Status Scoring System, and Newborn Comfort Behavior Scale. Demographic data will be compared between groups (maternal heartbeat sound group (Group 1), light human touch group (Group 2), combined maternal heartbeat sound and light human touch group (Group 3), and control group (Group 4)). Video recordings will be used to compare heart rate, behavioral status, and comfort scale scores obtained before, during, and after the interventions. The time it takes to fall asleep will also be evaluated. A t-test will be applied to evaluate the score differences between groups.

Conditions

• Comfort
• Behavior
• Heart Rate

Interventions

Type	Name	Description
BEHAVIORAL	Gentle Human Touch	the trained NICU nurse will place one hand's fingertips on the baby's forehead along the brow line, while the other hand will be placed around the baby's lower abdomen
BEHAVIORAL	Maternal Heartbeat and Gentle Human Touch	maternal heartbeat will be played and GHT steps will be applied simultaneously at the designated times
BEHAVIORAL	Maternal Heartbeat	The recording of the mother's heartbeat will be done when the mother's mood is stable and the environment is quiet. A Doppler fetal heart monitor will be used to detect the mother's heartbeat. After ensuring a regular and stable heart rate, the mother's heartbeat will be recorded for 15 minutes using a recording device

Timeline

• Start date: 2023-08-30
• Primary completion: 2023-09-03
• Completion: 2024-09-30
• First posted: 2024-12-09
• Last updated: 2025-06-03

Locations

1 site across 1 country: Turkey (Türkiye)