The Effect of Maternal Voice and Music Therapy on Pain and Stress During Heel Prick Testing in Newborns

NCT07773792 | Not Yet Recruiting

• 1 other identifier: Bilecik-BSEU4
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

During the adaptation process to the extrauterine environment, healthy newborns face procedures such as hepatitis B vaccination, vitamin K injection, blood sugar monitoring, bilirubin or metabolic disease screening. Heel prick blood sampling, performed for diagnostic purposes, is one of the most frequently performed procedures on newborns. Studies show that heel prick blood sampling holds an important place among invasive procedures performed on newborns. The heel prick blood sampling procedure, frequently performed on newborns, is... It has been reported that pain perception causes stress, and consequently, an increase in heart rate (HR) and blood pressure, a decrease in oxygen saturation (SpO2), and crying Following routine invasive procedures that cause pain, such as heel prick blood tests, children may experience negative physiological, metabolic, and behavioral responses as stress, duration, and intensity of pain increase. Increases in heart rate, respiratory rate, and blood pressure are observed due to the release of catecholamines, glucagon, and steroids following painful stimuli, and these physiological changes observed in response to pain are thought to play a role in initiating ischemic changes by leading to intraventricular hemorrhage and white matter damage around the ventricle. If pain is not effectively relieved or eliminated during this period, it can lead to neurological and behavioral disorders in later stages. Excessive and prolonged pain, particularly that resulting from invasive procedures, causes behavioral stress and physiological imbalances. It is believed that any painful invasive procedure can hinder a child's behavior, feeding habits, interaction with the mother, and adaptation to the environment. Furthermore, experiencing pain can influence subsequent pain behaviors, leading to a lifelong sensitivity to pain in the child. To reduce the effects of invasive procedures on newborns, effective pain management is divided into two categories: pharmacological and non-pharmacological. Non-pharmacological pain management strategies in children are defined as any strategy or technique applied to a child in pain to reduce their experience of pain. Recorded maternal voice and maternal heartbeat listening, music therapy are some of the non-pharmacological methods used in children. Music therapy is noted as one of the non-pharmacological methods widely used in postoperative analgesia, possessing effects such as increasing endorphin release, reducing catecholamine levels and thus decreasing the need for analgesics, stabilizing heart rhythm and respiratory rate, maintaining hemodynamic balance, influencing regional cardiac activity, and lowering blood pressure.

Conditions

Newborn; Maternal Voice; Music Therapy; Heel Prick Testing

Keywords

newborn; Heel Prick Testing; maternal voice; music therapy

Outcome Measures

Primary Outcomes (1)

• Neonatal Infant Pain Scale

  The Neonatal Infant Pain Scale (NIPS) was developed by Lawrence et al. (1993) and adapted into Turkish by Akdovan (1999). It is a pain assessment scale developed for preterm and newborn infants, which evaluates the behavioural response to pain during invasive procedures. The total score on the NIPS ranges from 0 to 7, with scores above 3 indicating the presence of pain.

  Baseline / Pre-encounter

Secondary Outcomes (1)

• Neonatal Stress Scale

  Baseline / Pre-encounter

Study Arms (1)

The Effect of Maternal Voice and Music Therapy on Pain and Stress

EXPERIMENTAL

The Effect of Maternal Voice and Music Therapy on Pain and Stress During Heel Prick Testing in Newborns

Other: Music Therapy; Other: Maternal Voice

Interventions

Music Therapy OTHER

In the group where Music Therapy will be applied, the heel prick blood test procedure and the study will be explained to the newborn and their parents. After obtaining consent, music therapy will be applied to the newborn 5 minutes before, during, and after the procedure. During this time, data will be recorded on a form by the observer. The song "The Happiest Child," developed by Fulya Merve KOS, a researcher with a Rhythm Therapist™ certificate issued by the Ministry of National Education, will be used in music therapy. The sound will be adjusted to 45 dB. The speaker will be placed at the tip of the newborn's foot, approximately 30 cm away from their ear, five minutes before the procedure and played to the child during the procedure. This sound will be played to the child 5 minutes before, during, and 5 minutes after the heel prick blood test, and data will be recorded by two observers and evaluated using the Newborn Infant Pain Scale (NIPS) and the Newborn Stress Scale.

The Effect of Maternal Voice and Music Therapy on Pain and Stress

Maternal Voice OTHER

In the group where the mother's voice will be used, the child's parents will be informed that the mother's voice will be used for pain relief in the study. For each newborn whose heel prick blood sample is taken by the researcher, the mother's voice will be recorded using a voice recorder. To play the mother's voice, the voice recorder will be placed 50 cm away from the child and the measurement will be taken. The sound level of the mother's voice will be set to an average of 45 decibels. The speaker will be placed at the tip of the newborn's foot, approximately 30 cm away from the ear, five minutes before the procedure and will be played to the child during the procedure. The child will be played this voice 5 minutes before, during, and 5 minutes after the heel prick blood sample is taken. Data will be recorded by two observers and evaluated using the Neonatal Infant Pain Scale (NIPS) and the Neonatal Stress Scale.

The Effect of Maternal Voice and Music Therapy on Pain and Stress

Eligibility Criteria

• Age: 0 Days - 40 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns within the first 24-48 hours after birth or 7-14 days old
• At least 2 hours after the last painful intervention
• Children whose parents agreed to participate in the study were included.

You may not qualify if:

• Presence of hearing impairment
• Absence of Parental Consent Form

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

Study Sites (1)

Bilecik Seyh Edebali University

Bilecik, Turkey, 11230, Turkey (Türkiye)

Location

Related Publications (1)

• No publications resulting from this study are available at this time as the trial is currently ongoing.

  BACKGROUND

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Fulya Merve FMK KOS, Assis Prof Dr

CONTACT

05300974816; fulya.kos@bilecik.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assis Prof Dr

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: August 19, 2026
• Study Start: July 29, 2026
• Primary Completion: August 17, 2026
• Study Completion: September 1, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)