Clinical trial NCT06167551: The Effect of 3 Different Auditory Applications on Newborn Heel Prick Procedure
Official title: The Effect of 3 Different Auditory Applications on Pain, Crying Duration and Physiological Parameters During Newborn Heel Prick Procedures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Newborn Pain
Keywords: newborn
heel prick
music
pain care
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 24
Sex: ALL
Minimum age (years): 24
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of 3 different auditory applications with the control group during heel prick collection in newborns.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: In pain management of newborns in interventional applications, health professionals should be able to evaluate pain and reduce or eliminate pain. Pharmacological and non-pharmacological methods are used in the management of pain. Non-pharmacological methods: practices such as breastfeeding, giving a pacifier, giving oral sucrose, listening to music, massage, therapeutic touching and nesting, positioning the fetus such as wrapping, giving kangaroo care, rocking and holding.

The newborn's response to sound often leads to changes in breathing and heart rate. Mild to moderate sounds (55-75 dB), such as speech and music, cause a decrease in heart rate and create an orientation response. Music makes positive changes in oxygen saturation level and heart rate peak values, and also reduces stress and pain. Arnon et al. determined that letting newborns in intensive care listen to music has a positive effect on reducing pain and anxiety, making it easier for newborns to fall asleep and increasing their sleep quality. Classical music with a light rhythmic emphasis and constant rhythm accompanied by a simple human voice or a single instrument, music performed by female vocalists (mother's voice, lullabies with a female voice) and white noise similar to intrauterine sounds are among the types of music that have a positive effect on newborns.

Heel prick pricking in newborns causes pain, which results in increased blood pressure and pulse rate, decreased SpO2, and crying. For this reason, this study was designed as a randomized controlled experimental design to compare the classical music and white noise and lullaby applications to the newborn before and during heel blood collection with the control group and to determine which application provides superior results on the newborn's pain level, crying duration and physiological parameters.

Research Purpose and Type This research was planned as a randomized controlled experimental design to compare the lullaby, classical music and white noise aplications to the newborn during the heel prick prick procedure with the control group.

Research Variables Independent variables; Lullaby your mother sings, white noise, classical music Dependent variables; Heart rate peak (HRV), oxygen saturation (SpO2), NIPS score, NIAPAS score, crying duration.

Place and Time to Conduct the Research The research will be carried out between February 2024 and June 2024 in the Neonatal Intensive Care Unit of Gaziantep Cengiz Gökçek Gynecology and Children's Hospital.

The population of the research It will create term newborns born at 38-42 weeks of gestation in the Neonatal Intensive Care Unit of Gaziantep Cengiz Gökçek Gynecology and Children's Hospital between February 2024 and June 2024. Postpartum 24-72. These are the newborns whose heel blood will be taken during Sample; The sample number of the study was determined by power analysis. The thesis study, which evaluated the effect of different auditory interventions on pain in heel blood collection in newborns, was taken as an example. According to the NIPS pain assessment scale used in the study, the average score of the results during the procedure was 4.26±2.16 in the 1st experimental group, 4.81±2.18 in the 2nd experimental group, 5.02±2.00 in the 3rd experimental group, and 5.93±1.32 in the control group. In this study, it was anticipated that the NIPS score average difference would have a large effect size (.95 large effect), with a 5% alpha margin of error (two-sided) and 80% power, and in the calculation of the number of samples made in the G\*Power (3.1.9.2.) program, each It was determined that 20 babies should be included in a group, 80 babies in total. Considering that there may be sample loss for any reason during the research, the aim is to reach 96 newborns (24 babies in each group) by increasing the number of babies by 20% and using statistical parametric analysis methods.

The sample will be randomly selected from the study population. In the study, randomization will be performed using the URN method, which is considered equivalent to the full randomization method. Although this method is shown as UD, it includes two parameters, α and β. These represent balls of two different colors (for example: red and white). α can be white or red, while β will be the exact opposite of the chosen ball colour. One of the balls is chosen randomly, and if the selected ball is white, the subject is assigned to the α group, and if it is red, the subject is assigned to the β group. This selection process is repeated to determine which group the subject will be in.

In the research, the red ball will be the mother's lullaby (intervention group 1), the yellow ball will be white noise (intervention group 2), the blue ball will be classical music (intervention group 3), and the white ball will be the control group. When there is a baby in the clinic that meets the sample selection conditions, these balls prepared by the researcher will be placed in an invisible, dark-colored bag and a random nurse working in the ward will be able to make the selection without seeing it. Which group the baby will be placed in will be determined by the color of the ball coming out of the bag, and the babies will be distributed randomly to the groups.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Cardiac apex beat (HRV)
timeFrame: 5 minutes before heel blood collection and at 1, 3 and 5 minutes during heel blood collection.
measure: Oxygen saturation (SpO2)
timeFrame: 5 minutes before heel blood collection and at 1, 3 and 5 minutes during heel blood collection.
measure: NIPS scale score
timeFrame: NIPS will be evaluated 5 minutes before the heel prick and at 1, 3 and 5 minutes during the heel prick.
measure: NIAPAS scale score
timeFrame: NIAPAS will be evaluated 5 minutes before the heel prick and at 1, 3 and 5 minutes during the heel prick.
measure: Crying time
timeFrame: The baby's crying time will be 5 minutes before the heel prick and 5 minutes during the heel prick.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ISTANBUL UNİVERSİTY CERRAHPAŞA
name: Serap BALCI, PHD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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
citation: 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
citation: İmseytoğlu, D., & Yıldız, S. (2012). YENİDOĞAN YOĞUN BAKIM ÜNİTELERİNDE MÜZİK TERAPİ. Florence Nightingale Journal of Nursing, 20(2), 160-165.
citation: 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.
citation: 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.
citation: 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.