The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-12
SponsorBaskent University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants aged 2 to 12 months
Undergoing surgery due to congenital heart disease
Having a single chest tube
Not receiving mechanical ventilation support
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Music Group
BehavioralSoft, 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
BehavioralA 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.
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: Music GroupExperimental treatment 1 intervention
Group B: Musical Mobile GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
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
[Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]Secondary outcomes
1
Heart rate
Heart rate will be monitored and recorded at specified time points using a bedside monitor.
Time frame
[Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]2
Oxygen saturation (SpO₂)
Oxygen saturation will be measured using a bedside monitor and recorded at specified time points.
Time frame
[Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]3
Crying Duration
Crying duration will be recorded in seconds throughout the chest tube removal procedure.
Time frame
Time Frame: Periprocedural (during chest tube removal procedure)]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov