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

NCT ID: NCT06724328

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2024-09-30

Brief Summary

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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

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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

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Comfort Behavior Heart Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Maternal Heartbeat

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.

Group Type EXPERIMENTAL

Maternal Heartbeat

Intervention Type 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

Gentle Human Touch

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

Group Type EXPERIMENTAL

Gentle Human Touch

Intervention Type 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

Maternal Heartbeat and Gentle Human Touch

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.

Group Type EXPERIMENTAL

Maternal Heartbeat and Gentle Human Touch

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Maternal Heartbeat and Gentle Human Touch

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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

32 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Gülçin Özalp Gerçeker

Proffesor, Pediatric Nursing Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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DEUttouch

Identifier Type: -

Identifier Source: org_study_id

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