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

16 août 2026 mis à jour par: Fulya Kos, Bilecik Seyh Edebali Universitesi

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Oui

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
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.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Neonatal Infant Pain Scale
Délai: Baseline / Pre-encounter
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Neonatal Stress Scale
Délai: Baseline / Pre-encounter
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

29 juillet 2026

Achèvement primaire (Estimé)

17 août 2026

Achèvement de l'étude (Estimé)

1 septembre 2026

Dates d'inscription aux études

Première soumission

16 août 2026

Première soumission répondant aux critères de contrôle qualité

16 août 2026

Première publication (Réel)

19 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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