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RECRUITING Not applicable ClinicalTrials.gov

Classical Music, Pain, and Physiological Parameters in Children Undergoing Two Aspiration Procedures

Sponsor: Bandırma Onyedi Eylül University • ClinicalTrials.gov ID: NCT07882615

Registry updated: 2026-10-20
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Description

Intensive care units (ICUs) are high-technology, high-performance units where patients with life-threatening conditions receive advanced nursing care and continuous monitoring. Pediatric intensive care units (PICUs), a specialized area within ICUs, provide closer observation and treatment than general wards and deliver services in a separate unit. Among the treatments frequently used during PICU stays, children most often receive mechanical ventilation (MV), endotracheal tube, or tracheostomy support because of respiratory diseases and respiratory failure. Endotracheal intubation is the most common means of securing the airway. It is indispensable for airway control in PICUs and is of primary importance for ensuring optimal ventilation and oxygenation. Children receiving MV are exposed to painful stimuli an average of 10-14 times per day, and endotracheal suctioning is one of the most painful procedures for these children. Tracheostomy is a surgical method used to maintain airway patency. Tracheostomy suctioning is part of routine care aimed at preventing infection and obstruction, while also maintaining airway patency. Suctioning is an important nursing intervention in PICU patients with an endotracheal tube or tracheostomy to maintain airway patency and prevent potential infections. Following routine invasive procedures that cause pain, such as suctioning, adverse physiological, metabolic, and behavioral responses may develop in children as stress and the duration and intensity of pain increase. The literature indicates that suctioning causes physiological changes such as pain, restlessness, tachycardia, hypertension, and decreased oxygen saturation, and that these effects are more pronounced in pediatric patients. This necessitates a holistic approach to health that links pain not only to physical conditions but also to psychological and emotional processes. However, the limited doses in which pharmacological analgesics can be used in pediatric patients, the risk of side effects, and the fact that sedation before a procedure is not always possible increase the importance of alternative pain management methods. In this context, nonpharmacological interventions such as listening to classical music can be used both to reduce the pain children experience during procedures and to regulate physiological stress responses. Studies have shown that pain perception decreases, heart rate and respiratory rate are regulated, and anxiety is markedly reduced in children who listen to classical music. The effect of music is based on the stimulation of emotional centers through the limbic system and, through this pathway, the balancing of physiological parameters such as heart rate, blood pressure, and respiration via the autonomic nervous system. Accordingly, this study aims to comparatively examine the effects of classical music played during two different suctioning methods (endotracheal and tracheostomy suctioning) on pain levels and physiological parameters in children receiving care in a pediatric intensive care unit. The limited number of studies on classical music applied during specific, brief invasive procedures such as suctioning underscores the originality of this study and increases its potential to contribute to evidence-based practice in pediatric nursing.

Interventions

  • Classical Music Group (Behavioral)
    To protect children's hearing, sound levels will be measured for each child with a Benetech GM1352 sound level meter and set at 45 dB, the short-term exposure level recommended by the APA. Bach's Air on the G String and Mozart's Clarinet Concerto in A Major, K. 622: I. Allegro will be played sequentially. The instrumental music will be short, fluid, non-lyrical, low-pitched, and minimally percussive, without dramatic or dissonant minor chords. Ten minutes before the procedure, a speaker will be placed approximately 30 cm from the child's ear, beside the foot. Before the music begins, the researcher will record each child's pulse, blood pressure, respiratory rate, oxygen saturation, and pain score. Music will then play for 20 minutes, including during suctioning performed by two nurses, as is routine PICU practice. Pain scores and physiological parameters will be monitored and recorded during the procedure and again 10 minutes afterward.

Eligibility criteria

Inclusion Criteria: * The child must be between 1 and 72 months of age (the Pediatric Intensive Care Unit at Bursa Dörtçelik Children's Hospital admits patients to the pediatric intensive care unit starting at 1 month of age); * Must have passed the newborn audiology screening; * Must require endotracheal or tracheostomy suctioning; * Must have stable hemodynamic parameters monitored on a monitor: "Heart rate: (80-130 beats per minute), blood pressure (systolic): (60-105 mmHg), blood pressure (diastolic): (20-66 mmHg), respiratory rate: (20-50 breaths per minute), oxygen saturation: (90-100%), * At least two hours must have elapsed since the last painful procedure; * Written informed consent from the parent indicating voluntary participation in the study. Exclusion Criteria: * Having a hearing impairment * A parent's desire to leave the workforce at any stage.

Conditions

Endotracheal Aspiration Tracheostomy Patients Children

Locations

  • Dörtçelik Children's Hospital — Bursa, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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