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

Maternal Heartbeat Sounds and Therapeutic Touch

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06724328
Acronym
heartbeatt
Enrollment
120
Registered
2024-12-09
Start date
2023-08-30
Completion date
2024-09-30
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comfort, Behavior, Heart Rate

Keywords

Newborn, therapeutic touch, maternal heart, behavior

Brief 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.

Interventions

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

BEHAVIORALMaternal Heartbeat and Gentle Human Touch

maternal heartbeat will be played and GHT steps will be applied simultaneously at the designated times

BEHAVIORALMaternal 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

Sponsors

Dokuz Eylul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
32 Weeks to 40 Weeks
Healthy volunteers
No

Inclusion criteria

* • Newborns between \>32 and ≤40 weeks gestational age. * Admission to neonatal intensive care unit (NICU) after birth. * Parental consent form obtained.

Exclusion criteria

* • Absence of neurological and cardiac problems. * No use of corticosteroids. * No use of muscle relaxants. * Not past the postnatal 10th day. * Not receiving non-invasive or invasive respiratory support.

Design outcomes

Primary

MeasureTime frameDescription
comfort0 minutes (pre-intervention), 5 minutes, 15 minutes, and 20 minutes (post-intervention)It is a Likert-type scale consisting of seven parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tonus. As well as determining comfort, the COMFORTneo scale is a tool that includes numeric rating scales, which allow nurses to assess the pain and distress of the infant. The lowest score on the scale is 6, and the highest is 30. If the total score on the scale is between 14 and 30, the infant has pain or distress, is uncomfortable, and needs intervention to provide comfort. In addition, 4-6 points indicate moderate pain and distress, and 7-10 points indicate severe pain and distress

Secondary

MeasureTime frameDescription
behavior0 minutes (pre-intervention), 5 minutes, 15 minutes, and 20 minutes (post-intervention)It developed by Anderson et al. in 1990, evaluates the baby's sleep-wake states through 12 categories of behavioral states. ABSS involves 12 categories, including measuring the extent of eye openness, patterns of respiration, body movement, muscle tension, and crying with or without sound, to assess the behavioral state of term infants as well as premature infants. Categories 1-5 pertain to sleep states, 6-8 pertain to wakefulness and calmness, and 9-12 pertain to discomfort and distress. High scores indicate negative behaviors, while low scores indicate positive behaviors.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026