- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07773792
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
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
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Fulya Merve FMK KOS, Assis Prof Dr
- Numéro de téléphone: 05300974816
- E-mail: fulya.kos@bilecik.edu.tr
Lieux d'étude
-
-
Turkey
-
Bilecik, Turkey, Turquie (Türkiye), 11230
- Bilecik Seyh Edebali University
-
Contact:
- Fulya KOS
- Numéro de téléphone: 05300974816
- E-mail: fulya.kos@bilecik.edu.tr
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
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
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
Parrainer
Publications et liens utiles
Publications générales
- No publications resulting from this study are available at this time as the trial is currently ongoing.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Bilecik-BSEU4
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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
Étudie un produit d'appareil réglementé par la FDA américaine
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 .