The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters (Music Pain Inf)

The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters During Chest Tube Removal in Infants Undergoing Congenital Heart Surgery

Chest tube removal in infants undergoing surgery for congenital heart disease is an invasive procedure associated with significant pain and physiological stress responses. This randomized controlled trial evaluates the effects of music and musical mobile interventions on pain and physiological parameters during chest tube removal. A total of 54 infants aged 2-12 months are randomly assigned to music, musical mobile, or control groups. Pain is assessed using the FLACC scale, and physiological parameters (heart rate and oxygen saturation [SpO₂]) are monitored. Measurements are obtained at predefined time points: periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal). The findings aim to support evidence-based non-pharmacological pain management in pediatric intensive care settings.

Study Overview

• Status: Not yet recruiting
• Conditions: Chest Tube Removal; Congenital Heart Disease (CHD)
• Intervention / Treatment: Behavioral: Music Group; Behavioral: Musical Mobile Group

Detailed Description

Chest tube removal is a common but painful procedure in infants undergoing surgery for congenital heart disease and may trigger significant physiological stress responses. Although pharmacological interventions are commonly used, concerns about potential side effects highlight the importance of non-pharmacological approaches.

This study is a randomized controlled trial designed to evaluate the effects of music and musical mobile interventions on procedural pain and physiological parameters. The study is conducted in the Pediatric Cardiovascular Surgery Intensive Care Unit of Başkent University Ankara Hospital. The sample consists of 54 infants aged 2-12 months who meet the eligibility criteria.

Participants are randomly allocated to three groups (music, musical mobile, and control) using block randomization. In the music group, auditory stimulation consisting of ocean and nature sounds is initiated 10 minutes before chest tube removal, continued during the procedure, and maintained for 5 minutes after the procedure. In the musical mobile group, a multisensory intervention combining auditory and visual stimuli is applied during the same time interval. The control group receives standard care routinely provided in the unit.

Pain is assessed using the FLACC Scale. Physiological parameters, including heart rate and oxygen saturation (SpO₂), are monitored using bedside monitors. Outcomes are recorded at predefined time points: periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal). Crying duration is recorded continuously during the chest tube removal procedure.

Statistical analyses are performed using SPSS software. Depending on data distribution, appropriate parametric or non-parametric tests are applied. This study aims to provide evidence on the effectiveness of multisensory distraction interventions in reducing procedural pain and improving physiological stability in infants undergoing chest tube removal.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayşe Ay, RN, Associate Professor; Phone Number: +905073560214; Email: ayseay@baskent.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Infants aged 2 to 12 months
• Undergoing surgery due to congenital heart disease
• Having a single chest tube
• Not receiving mechanical ventilation support
• Parent(s) voluntarily agree to participate in the study

Exclusion Criteria:

• Receiving mechanical ventilation support
• Administration of analgesics within 2 hours prior to chest tube removal
• Presence of a neurodevelopmental disorder
• Parent(s) do not consent to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; standart care
Experimental: Music Group; Soft, slow-tempo instrumental music	Behavioral: Music Group; Soft, slow-tempo instrumental music will be played starting 10 minutes before chest tube removal, continued during the procedure, and maintained for 5 minutes after the procedure.
Experimental: Musical Mobile Group; soft, slow-tempo instrumental music with visual movement	Behavioral: Musical Mobile Group; A musical mobile providing audio-visual stimulation (soft, slow-tempo instrumental music with visual movement) will be used starting 10 minutes before the procedure, during, and for 5 minutes after.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level assessed by FLACC Scale	Pain will be evaluated using the FLACC (Face, Legs, Activity, Cry, Consolability) Scale. Scores range from 0 to 10, with higher scores indicating greater pain intensity.	[Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate will be monitored and recorded at specified time points using a bedside monitor.	[Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
Oxygen saturation (SpO₂)	Oxygen saturation will be measured using a bedside monitor and recorded at specified time points.	[Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
Crying Duration	Crying duration will be recorded in seconds throughout the chest tube removal procedure.	Time Frame: Periprocedural (during chest tube removal procedure)]

Collaborators and Investigators

• Sponsor: Baskent University

Publications and helpful links

General Publications

• 1. Arabiat, D., Mörelius, E., Hoti, K., & Hughes, J. (2023). Pain assessment tools for use in infants: a meta-review. BMC pediatrics, 23(1), 307. 2. Bates, K. E., Madsen, N. L., Khadr, L., Gao, Z., Crawford, K., Gaies, M., Graupe, M., Hanke, S. P., Hlavacek, A. M., Morell, E., Pasquali, S. K., Russell, J. L., Schachtner, S. K., Tanel, R. E., Ware, A. L., & Kipps, A. K. (2021). Center Variation in Chest Tube Duration and Length of Stay After Congenital Heart Surgery. The Annals of thoracic surgery, 110(1), 221-227. https://doi.org/10.1016/j.athoracsur.2019.09.078 3. Bertrandt, R. A., Saudek, D. M., Scott, J. P., Madrzak, M., Miranda, M. B., Ghanayem, N. S., & Woods, R. K. (2019). Chest tube removal algorithm is associated with decreased chest tube duration in pediatric cardiac surgical patients. The Journal of thoracic and cardiovascular surgery, 158(4), 1209-1217. 4. Blinder, J. J., Thiagarajan, R., Williams, K., Nathan, M., Mayer, J., & Kulik, T. J. (2017). Duration of mechanical ventilation and perioperative care quality after neonatal cardiac operations. The Annals of Thoracic Surgery, 103(6), 1956-1962. https://doi.org/10.1016/j.athoracsur.2016.11.077 5. Clarke, S. L., Milburn, N. C., Menzies, J. C., & Drury, N. E. (2024). The provision and impact of rehabilitation provided by physiotherapists in children and young people with congenital heart disease following cardiac surgery: a scoping review. Physiotherapy, 122, 47-56. https://doi.org/10.1016/j.physio.2023.09.001 6. Duran Küçük, G. (2025). Çocuklarda göğüs tüpü çıkarma işlemi öncesi uygulanan lidokain-prilokain krem ve soğuk uygulamanın ağrı, anksiyete ve yaşamsal bulgulara etkisi: Randomize kontrollü çalışma (Yayımlanmamış yüksek lisans tezi). İstanbul Medeniyet Üniversitesi, Lisansüstü Eğitim Enstitüsü. 7. Ertürk, E. B., & Karadağ, M. (2020). Göğüs tüpü çıkarılma işleminin neden olduğu ağrı ve anksiyetenin kontrolünde uygulanan farmakolojik olmayan yöntemler. Türk Hemşireler Derneği Dergisi, 1(1), 53-68.

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Nursing; Chest Tube Removal; Multisensory Distraction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: KA26/146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No