- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Fulya Merve FMK KOS, Assis Prof Dr
- Telefonnummer: 05300974816
- E-post: fulya.kos@bilecik.edu.tr
Studieorter
-
-
Turkey
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Bilecik, Turkey, Turkiet (Türkiye), 11230
- Bilecik Seyh Edebali University
-
Kontakt:
- Fulya KOS
- Telefonnummer: 05300974816
- E-post: fulya.kos@bilecik.edu.tr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Neonatal Infant Pain Scale
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Neonatal Stress Scale
Tidsram: 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
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- No publications resulting from this study are available at this time as the trial is currently ongoing.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Bilecik-BSEU4
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
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