Endotracheal AspirationNCT07882615
Classical Music, Pain, and Physiological Parameters in Children Undergoing Two Aspiration Procedures
A study testing Classical Music Group in people with Endotracheal Aspiration and Tracheostomy Patients, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 month to 72 months
- Conditions the study is for
- Endotracheal Aspiration, Tracheostomy Patients, Children
- What is being tested?
- Classical Music Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Having a hearing impairment
- A parent's desire to leave the workforce at any stage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dörtçelik Children's Hospital
Bursa
Bernis ER, berniser21@gmail.com
Zübeyde Ezgi ERÇELİK, Assistant Professor
About this study
Official title: The Effect of Classical Music Played During Two Different Suctioning Procedures on Pain and Physiological Parameters in Children
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.
Read more
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.
- Conditions
- Endotracheal Aspiration, Tracheostomy Patients, Children
- Being tested
- Classical Music Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical Music GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Classical Music Group | Experimental | 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. Receives: Behavioral: Classical Music Group |
| Standart Care Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 10 minutes before the procedure, during the procedure, and 10 minutes after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start2 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal AspirationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zubeyde Ezgi Ercelik, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882615
- Sponsor's protocol ID
- E-25691463-050.04-2500079580
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Classical Music Played During Two Different Suctioning Procedures on Pain and Physiological Parameters in Children
- ClinicalTrials.gov ID
- NCT07882615
- Acronym / sponsor ID
- E-25691463-050.04-2500079580
- Conditions
- Endotracheal Aspiration, Tracheostomy Patients, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 2 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classical Music Group | Experimental | Behavioral: Classical Music GroupTo 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. |
| Standart Care Group | No intervention | –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. |
Who may qualify
- Ages
- 1 month to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- Having a hearing impairment
- A parent's desire to leave the workforce at any stage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classical Music GroupTo 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. | Behavioural | Classical Music Group |
Primary outcome
FLACC Pain Assessment Scale
Time frame: 10 minutes before the procedure, during the procedure, and 10 minutes after the procedure.
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).
Physiological Parameters Form
Time frame: 10 minutes before the procedure, during the procedure, and 10 minutes after the procedure.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Endotracheal Aspiration
RecruitingObservational study
VENtilation Modalities During Transport of PostoperatIve CRITically Ill Patients to the ICU
Respiration, Artificial, Positive-Pressure Respiration
Not yet recruitingObservational study
Surveillance of Neonatal Endotracheal Tube Colonisation
Ventilation, Mechanical, Ventilation-Associated Pneumonia
Recruiting
Preoxygenation for Tracheal Aspirations in Intensive Care
ICU Patients Under Invasive Mechanical Ventilation
Not yet recruiting
Ramped Versus Supine Position for Emergent Endotracheal Intubation in Adult Patients; Prospective, Randomized, Comparative Study
Intubation Complications
Not yet recruiting
Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection
Nosocomial Infection, Nosocomial Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical Music Group in people with Endotracheal Aspiration and Tracheostomy Patients, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zübeyde Ezgi ERÇELİK, Asistant Professor (+90 266 717 0117, zezgiozgenn5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC Pain Assessment Scale (time frame: 10 minutes before the procedure, during the procedure, and 10 minutes after the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.