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

NCT06724328 | Completed DMC

• 1 other identifier: DEUttouch
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Comfort; Behavior; Heart Rate

Keywords

Newborn, therapeutic touch, maternal heart, behavior

Outcome Measures

Primary Outcomes (1)

• comfort

  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

  0 minutes (pre-intervention), 5 minutes, 15 minutes, and 20 minutes (post-intervention)

Secondary Outcomes (1)

• behavior

  0 minutes (pre-intervention), 5 minutes, 15 minutes, and 20 minutes (post-intervention)

Study Arms (4)

Control Group

NO INTERVENTION

In this group, preterm infants will be recorded with a camera for 20 minutes between 13:00-13:20, 19:00-19:20, and 01:00-01:20, after their routine care and feeding have been completed, with no interventions applied to the baby.

Maternal Heartbeat

EXPERIMENTAL

Researchers will schedule a time with the mother within 48 hours after the baby's birth to record the 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.

Behavioral: Maternal Heartbeat

Gentle Human Touch

EXPERIMENTAL

GHT will be applied to the babies at the designated times.

Behavioral: Gentle Human Touch

Maternal Heartbeat and Gentle Human Touch

EXPERIMENTAL

For this group, maternal heartbeat will be played and GHT steps will be applied simultaneously at the designated times. Camera recording will start 2 minutes before the intervention and continue for an additional 2 minutes after the intervention.

Behavioral: Maternal Heartbeat and Gentle Human Touch

Interventions

Gentle Human Touch BEHAVIORAL

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

Gentle Human Touch

Maternal Heartbeat and Gentle Human Touch BEHAVIORAL

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

Maternal Heartbeat and Gentle Human Touch

Maternal Heartbeat BEHAVIORAL

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

Maternal Heartbeat

Eligibility Criteria

• Age: 32 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor, Pediatric Nursing Department

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: August 30, 2023
• Primary Completion: September 3, 2023
• Study Completion: September 30, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

TU (1)