Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

11mo left

Started Jun 2026

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

Study Progress9%

Jun 2026Jun 2027

First Submitted

Initial submission to the registry

April 27, 2026

Completed

7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed

2 months until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

April 27, 2026

Last Update Submit

July 13, 2026

Conditions

Congenital Heart Disease (CHD)Chest Tube Removal

Keywords

Chest Tube RemovalNursingCongenital Heart DiseaseMultisensory Distraction

Outcome Measures

Primary Outcomes (1)

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 Outcomes (3)

Heart rate
[Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
Oxygen saturation (SpO₂)
[Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
Crying Duration
Time Frame: Periprocedural (during chest tube removal procedure)]

Study Arms (3)

Music Group

EXPERIMENTAL

Soft, slow-tempo instrumental music

Behavioral: Music Group

Musical Mobile Group

EXPERIMENTAL

soft, slow-tempo instrumental music with visual movement

Behavioral: Musical Mobile Group

Control Group

NO INTERVENTION

standart care

Interventions

Music GroupBEHAVIORAL

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.

Music Group

Musical Mobile GroupBEHAVIORAL

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.

Musical Mobile Group

Eligibility Criteria

Age2 Months - 12 Months

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Baskent Universitylead

Study Sites (1)

Başkent University Ankara Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (1)

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.
BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ayşe Ay, RN, Associate Professor

CONTACT

+905073560214 ayseay@baskent.edu.tr

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

July 14, 2026

Record last verified: 2026-07

Locations

TU(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Music Group

Musical Mobile Group

Control Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Locations