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

Dokuz Eylül University (DEU)

Status: Completed

Conditions: Behavior; Comfort; Heart Rate

Treatments: Behavioral: Maternal Heartbeat and Gentle Human Touch; Behavioral: Gentle Human Touch; Behavioral: Maternal Heartbeat

Study type: Interventional

Funder types: Other

Identifiers

NCT06724328

DEUttouch

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 32 to 40 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Control Group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Maternal Heartbeat

Gentle Human Touch

Experimental group

Description:

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

Treatment:

Behavioral: Gentle Human Touch

Maternal Heartbeat and Gentle Human Touch

Experimental group

Description:

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.

Treatment:

Behavioral: Maternal Heartbeat and Gentle Human Touch