The Effect of 3 Different Auditory Applications on Newborn Heel Prick Procedure

NCT06167551 | Unknown

• 1 other identifier: TNKU-Z.BALKAN-1
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

In pain management of neonates in interventional applications, health professionals should be able to evaluate pain, reduce or eliminate pain. Pharmacologic and nonpharmacologic methods are used in pain management. Pharmacological, opioid analgesics, sedatives and local anesthetics are used. Nonpharmacologic methods include breastfeeding, giving pacifiers, oral sucrose, music, massage, therapeutic touch and nesting, positioning such as fetal positioning, wrapping, kangaroo care, rocking and cradling. Music makes positive changes in oxygen saturation level and peak heart rate values and reduces stress and pain. Classical music with light rhythmic emphasis and steady rhythm accompanied by a simple human voice or a single instrument, music performed by female vocalists (mother's voice, lullabies with female voice) and white noise similar to intrauterine sounds are among the types of music that have a positive effect on newborns. This study was planned as a randomized controlled experimental design to compare the lullaby, classical music and white noise song by the mother to the newborn before and during heel prick blood collection with the control group and to determine which application gives superior results to the newborn's pain level, crying time and physiological parameters.

Conditions

Newborn Pain

Keywords

newborn; heel prick; music; pain care

Outcome Measures

Primary Outcomes (5)

• Cardiac apex beat (HRV)

  HRV will be evaluated before and during heel blood collection. It will be recorded by the researcher during the blood collection process.

  5 minutes before heel blood collection and at 1, 3 and 5 minutes during heel blood collection.

• Oxygen saturation (SpO2)

  SpO2 will be evaluated before and during heel blood collection. It will be recorded by the researcher during the blood collection process.

  5 minutes before heel blood collection and at 1, 3 and 5 minutes during heel blood collection.

• NIPS scale score

  The scale is used to evaluate pain due to procedures performed in term and premature babies. NIPS consists of sections that evaluate 6 behaviors against pain (crying, breathing pattern, arm and leg movements and alertness). Although the total score varies between 0-7, a higher score indicates greater pain intensity.

  NIPS will be evaluated 5 minutes before the heel prick and at 1, 3 and 5 minutes during the heel prick.

• NIAPAS scale score

  NIAPAS scale measures acute pain; It is a scale that includes five behavioral and three physiological indicators given the week of gestation as a contextual factor. As a result of the scoring of the indicators, the score that can be obtained from the scale is between 0-18. Pain intensity is classified as mild pain (0-5), moderate pain (6-9) and severe pain (10-18).

  NIAPAS will be evaluated 5 minutes before the heel prick and at 1, 3 and 5 minutes during the heel prick.

• Crying time

  The baby's crying time will be monitored and recorded.

  The baby's crying time will be 5 minutes before the heel prick and 5 minutes during the heel prick.

Study Arms (4)

mother lullaby group

EXPERIMENTAL

group listening to mother's lullaby

Other: mother lullaby group

white noise group

EXPERIMENTAL

group listening to white noise

Other: white noise group

classical music group

EXPERIMENTAL

group listening to classical music

Other: classical music group

Control group

OTHER

No intervation

Other: Contol Group

Interventions

mother lullaby group OTHER

mother's lullaby: the mother will be made to sing her own lullaby 5 minutes before the heel prick.

mother lullaby group

white noise group OTHER

white noise: 5 minutes before taking heel prick blood, white noise will be started to be played on an MP3 player with white noise. The MP3 player will be placed in the crib where the baby lies, at the baby's bedside, at least 20 cm away from the baby's head. After the MP3 player is turned on, the sound level will be measured at the baby's ear level with a decibel meter and adjusted so that it does not exceed 70 decibels.

white noise group

classical music group OTHER

classical music: 5 minutes before heel prick, classical music will be started to be played from the MP3 player with white noise. The MP3 will be placed inside the crib where the baby lies, at the baby's bedside, at least 20 cm away from the baby's head. After the MP3 player is turned on, the sound level will be measured at the baby's ear level with a decibel meter and adjusted so that it does not exceed 70 decibels.

classical music group

Contol Group OTHER

No intervation

Also known as: No intervation

Control group

Eligibility Criteria

• Age: 24 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The newborn must be between 38-42 weeks and weigh appropriately for his/her week (Appropriate Gestational Age - AGA),
• Not taking any analgesic, sedative or anticonvulsant medication for at least 6 hours before,
• Feeding at least 1 hour before,
• No fever,
• Not receiving oxygen therapy,
• Not receiving antibiotic treatment
• No congenital anomalies
• Not next to the bed or under the heater
• Not receiving phototherapy,
• Not being connected to a mechanical ventilator

You may not qualify if:

• Presence of congenital anomaly,
• Having a chest tube inserted,
• Intracranial bleeding,
• Presence of anomaly that may cause deafness
• Those with a history of epileptic seizures will be excluded.
• The patient's family refuses to participate in the study.

Sponsors & Collaborators

• Namik Kemal University: lead

Related Publications (10)

• Arnon S, Shapsa A, Forman L, Regev R, Bauer S, Litmanovitz I, Dolfin T. Live music is beneficial to preterm infants in the neonatal intensive care unit environment. Birth. 2006 Jun;33(2):131-6. doi: 10.1111/j.0730-7659.2006.00090.x.

  PMID: 16732778 BACKGROUND

• Balcı, S. (2006). Beyaz Gürültünün Kolikli Bebeklerde Etkisi. Marmara Üniversitesi Sağlık Bilimleri Enstitüsü Çocuk Sağlığı ve Hastalıkları Hemşireliği Anabilim Dalı. Yüksek Lisans Tezi. İstanbul, Türkiye.

  BACKGROUND

• Balcı, S., Dur, Ş., Özdemir, Ş., & Kavuncuoğlu, S. (2021). The effect of two different lancets and heel warming on duration of crying and procedure time during blood sampling: A randomized controlled study. Journal of Neonatal Nursing, 27(6), 426-431.

  BACKGROUND

• Derebent, E., & Yiğit, R. (2008). Yenidoğanda Non-Farmakolojik Ağrı Yönetimi. Fırat Üniversitesi Sağlık Bilimleri Tıp Dergisi, 22(2), 113.

  BACKGROUND

• Gilad, E., & Arnon, S. (2010). The role of live music and singing as a stress-reducing modality in the neonatal intensive care unit environment. Music and Medicine, 2(1), 18-22

  BACKGROUND

• Gooding, L. F. (2010). Using music therapy protocols in the treatment of premature infants: An introduction to current practices. The arts in Psychotherapy, 37(3), 211-214

  BACKGROUND

• İmseytoğlu, D., & Yıldız, S. (2012). YENİDOĞAN YOĞUN BAKIM ÜNİTELERİNDE MÜZİK TERAPİ. Florence Nightingale Journal of Nursing, 20(2), 160-165.

  BACKGROUND

• Kanbur BN, Mutlu B, Salihoglu O. Validity and reliability of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS) in Turkish: prospective study. Sao Paulo Med J. 2021 Jul-Aug;139(4):305-311. doi: 10.1590/1516-3180.2020.0721.R1.23122020.

  PMID: 34346962 BACKGROUND

• Uyar M, Akin Korhan E. [The effect of music therapy on pain and anxiety in intensive care patients]. Agri. 2011 Oct;23(4):139-46. doi: 10.5505/agri.2011.94695. Turkish.

  PMID: 22290677 BACKGROUND

• Standley, J. M. (2012). A discussion of evidence-based music therapy to facilitate feeding skills of premature infants: The power of contingent music. The arts in Psychotherapy, 39(5), 379-382.

  BACKGROUND

Study Officials

• Serap BALCI, PHD

  ISTANBUL UNİVERSİTY CERRAHPAŞA

  STUDY DIRECTOR

Central Study Contacts

Zeynem YILDIRIM BALKAN, PHD

CONTACT

+905073190958; zyildirim@nku.edu.tr

Serap ÖZDEMİR, PHD

CONTACT

+905375438610; serap8685@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The baby's crying time will be monitored and recorded. KTA and SpO2 will be recorded by the researcher during blood collection. Pain assessment of the babies will be made by two independent neonatal nurses other than the researcher. Both observers must have worked in the clinic for at least 5 years. Analysis of the data will be done by an independent analyst, not by researchers.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Lecturer and Principal Investigator

Model Details: Comparison of 3 different auditory applications with the control group during heel prick collection in newborns.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: December 12, 2023
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share