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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07564882
Acronym
Music Pain Inf
Enrollment
54
Registered
2026-05-04
Start date
2026-04-30
Completion date
2027-06-30
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease (CHD), Chest Tube Removal

Keywords

Chest Tube Removal, Nursing, Congenital Heart Disease, Multisensory Distraction

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.

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.

Interventions

BEHAVIORALMusic 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.

BEHAVIORALMusical 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.

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Months to 12 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain level assessed by FLACC Scale[Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]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.

Secondary

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

Contacts

CONTACTAyşe Ay, RN, Associate Professor
ayseay@baskent.edu.tr+905073560214

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026