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 aims to evaluate the effects of music and musical mobile interventions on pain levels and physiological parameters during chest tube removal. A total of 54 infants aged 2-12 months will be randomly assigned to music, musical mobile, or control groups. Pain will be assessed using the FLACC scale, and physiological parameters (heart rate and oxygen saturation) will be monitored. Measurements will be taken before, during, and after the procedure. The findings are expected to contribute to evidence-based non-pharmacological pain management practices in pediatric intensive care settings.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

14mo left

Started Apr 2026

Status

not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

Study Progress2%

Apr 2026Jun 2027

First Submitted

Initial submission to the registry

April 27, 2026

Completed

3 days until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed

4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed

12 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

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Congenital Heart Disease (CHD)Chest Tube Removal

Keywords

Chest Tube Removal; Nursing; Congenital Heart Disease; Multisensory Distraction; Music Therapy

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.
10 minutes before, immediately after, and 5 minutes after chest tube removal

Secondary Outcomes (3)

Heart rate
10 minutes before, immediately after, and 5 minutes after chest tube removal
Oxygen saturation (SpO₂)
10 minutes before, immediately after, and 5 minutes after chest tube removal
Crying Duration
During chest tube removal

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 who have undergone surgery due to congenital heart disease, have a single chest tube, are not receiving mechanical ventilation support, and whose parents voluntarily agree to participate in the study will be included.

You may not qualify if:

Infants who are receiving mechanical ventilation support, have received analgesics within 2 hours prior to chest tube removal, have a neurodevelopmental disorder, or whose parents do not consent to participate in the study will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Baskent Universitylead

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

April 30, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

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

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates