An interventional study of Classical Music Group in Endotracheal Aspiration, Tracheostomy Patients and Children, sponsored by Bandırma Onyedi Eylül University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 1 Month to 72 Months. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Bandırma Onyedi Eylül University · Not applicable, Interventional, and Supportive care
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.
Bandırma Onyedi Eylül University is the lead sponsor of 69 studies on the registry; 18 are open to participants now.
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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.
Behavioral: Classical Music Group
No additional interventions will be performed on children in the Standard Care Group. The investigator and two nurses will follow a standard procedure before, during, and after endotracheal or tracheostomy aspiration, and the investigator will record the data on a form. No additional care will be provided to ensure physiological stability or alleviate pain.
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.
FLACC Pain Assessment Scale
It was developed in 1997 by Merkel and colleagues to assess pain in children and adults. Its validity and reliability in Turkish were established by Şenayli and colleagues (2006), and it is used to assess acute or postoperative pain in children aged 1 month to 9 years who are unable to express their pain or communicate. In children, the assessment is based on the evaluation of five behavioral categories (facial expressions, leg movements, activity level, crying, and responsiveness to comfort). The pain assessment scale is scored on a scale ranging from 0 to 10. Pain scores are classified as mild (0-3), moderate (4-6), and severe (7-10).
Time frame: 10 minutes before the procedure, during the procedure, and 10 minutes after the procedure.
Physiological Parameters Form
It will also be used to record the child's physiological parameters (heart rate, blood pressure \[systolic and diastolic\], respiratory rate, and oxygen saturation) before, during, and after the aspiration procedure.
Time frame: 10 minutes before the procedure, during the procedure, and 10 minutes after the procedure.
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Plan to share: No
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Bandırma Onyedi Eylül University