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NCT Number: NCT07564882

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

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.

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Key information

Age range

2 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başkent University Ankara Hospital

Ankara, Turkey (Türkiye)

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Group

Behavioral

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.

Musical Mobile Group

Behavioral

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.

Primary outcomes

  1. Pain level assessed by FLACC Scale

    Time frame: [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 outcomes

  1. Heart rate

    Time frame: [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.

  2. Oxygen saturation (SpO₂)

    Time frame: [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.

  3. Crying Duration

    Time frame: Time Frame: Periprocedural (during chest tube removal procedure)]

    Crying duration will be recorded in seconds throughout the chest tube removal procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşe Ay, RN, Associate Professor

CONTACT

[email protected]

+905073560214

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

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

Acronym: Music Pain Inf

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 4, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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