The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Music Group, Musical Mobile Group.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease (CHD), Chest Tube Removal. Basic parameters: 2 months — 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters During Chest Tube Removal in Infants Undergoing Congenital Heart Surgery
Overview
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
- 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. - 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.
Primary outcome measures
- 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)]]
Secondary outcome measures (3)
- Heart rate [Time frame: [Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]]
- Oxygen saturation (SpO₂) [Time frame: [Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]]
- Crying Duration [Time frame: Time Frame: Periprocedural (during chest tube removal procedure)]]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Başkent University Ankara Hospital — Ankara
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
Identifiers
NCT: NCT07564882 · KA26/146