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

Not Applicable

• Conditions: Comfort; Behavior; Heart Rate

• Registration Number: NCT06724328
• Lead Sponsor: Dokuz Eylul University

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 Newborn Information Form, 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)). chi-square and t-tests. 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.

Study Timeline

• Study Start: 2023-08-30
• Primary Completion: 2023-09-03
• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
comfort	0 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 Outcome Measures

Name	Time	Method
behavior	0 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.

Trial Locations

Locations (1)

Dokuz Eylul University; 🇹🇷 İzmir, Turkey