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

The Effect of Maternal Voice and Music Therapy on Pain and Stress During Heel Prick Testing in Newborns: A Randomised Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Newborn; Music Therapy; Maternal Voice; Heel Prick Testing
• Intervention / Treatment: Other: Music Therapy; Other: Maternal Voice

Detailed Description

It has been noted that one of the non-pharmacological methods used in effective pain management in children is the mother's voice. Although the mechanism underlying the effect of the mother's voice is not fully understood, it is stated that the mother's voice creates a calming environment for children. Studies have shown that listening to the mother's voice before and after invasive procedures performed on infants and children in intensive care units reduces pain. In a study conducted by Erdoğan et al., it was found that children aged 1-3 years who listened to their mother's voice during painful procedures had lower pain levels, lower heart rates, and higher oxygen saturation. It is emphasized that in critical care settings where mothers cannot be with their babies and children and cannot actively participate in their care, listening to the mother's voice is one of the approaches that can be used as an effective method in pain management.

It is known that non-pharmacological methods are effective in reducing pain in children and that they increase the effectiveness of drugs when used together with analgesics. Non-pharmacological methods are preferred because they are easy to apply and inexpensive, reduce the need for drug administration and thus the risk of side effects. Developing appropriate pain control strategies by knowing the effect of pain and related stress on children is both a medical and ethical responsibility.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fulya Merve FMK KOS, Assis Prof Dr; Phone Number: 05300974816; Email: fulya.kos@bilecik.edu.tr

Study Locations

• Turkey (Türkiye)
  • Turkey
    • Bilecik, Turkey, Turkey (Türkiye), 11230
      • Bilecik Şeyh Edebali University
      • Contact: Fulya KOS; Phone Number: 05300974816; Email: fulya.kos@bilecik.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Presence of hearing impairment
• Absence of Parental Consent Form

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Other: Music Therapy; 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.; Other: Maternal Voice; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Stress Scale	The Neonatal Stress Scale was developed by Ceylan and Bolışık (2017) to assess stress levels in premature infants. The scale consists of 24 items in total, including 8 subgroups covering facial expression, body color, respiration, activity level, soothing ability, muscle tone, extremities, and posture, using a 3-point Likert scale. Each subgroup is scored between 0 and 2 points. The minimum score on the scale is 0, and the maximum is 16. An increase in the score indicates an increased stress level in the infant. The scale is evaluated through observation. It is sufficient for the infant to exhibit only one of the behaviors in each cell of the scale for scoring. When the infant exhibits both of the signs (behaviors) in two different cells during observation (for example, when the infant exhibits signs corresponding to both 1 and 2 points), the highest value is valid. An infant whose condition is stable and balanced will receive a score of 0 on the scale. Infants b	Baseline / Pre-encounter

Collaborators and Investigators

• Sponsor: Bilecik Seyh Edebali Universitesi

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 29, 2026
• Primary Completion (Estimated): August 17, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 16, 2026
• First Submitted That Met QC Criteria: August 16, 2026
• First Posted (Actual): August 19, 2026

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 16, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: music therapy; newborn; maternal voice; Heel Prick Testing
• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Sensory Art Therapies; Music Therapy
• Other Study ID Numbers: Bilecik-BSEU4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual Participant Data (IPD) will not be made publicly available or shared for this study due to ethical considerations regarding participant confidentiality and the explicit terms of the informed consent protocol.

Specifically:

Informed Consent Constraints: The informed consent forms approved by the Institutional Review Board (IRB) / Ethics Committee and signed by the parents/guardians do not include permissions for raw, individual-level data sharing with external third parties or public repositories.

Privacy and Vulnerability: Given that the study population consists of pediatric patients undergoing clinical evaluations, raw IPD contains sensitive demographic and clinical details that could potentially compromise participant anonymity.

De-identified aggregate statistical data, protocol details, and final study findings will be made available through published peer-reviewed journal articles and clinical trial registries upon study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No