The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-17
SponsorClaudia Aristizábal
About this trial
The extubation process is critical to the future health outcomes of the pediatric patient because it tests the ability of the respiratory system to function without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety, or discomfort in the patients, which results in an increased likelihood of reintubation. Music therapy has been shown to be effective in reducing anxiety and stress levels in ventilated adult patients, but studies evaluating the effect of music therapy on vital signs in pediatric patients during extubation are lacking.
The aim is to determine the effect of music therapy on vital signs and heart rate variability of pediatric patients during extubation in in two high-complexity health care institutions in Colombia.
This study is a Randomized clinical trial (RCT) with two parallel arms. The intervention group (IG) will receive standard care during the extubation process + music therapy and the control group (CG) will receive standard care only. The primary outcome measure is heart rate (HR) measured every minute for 5 minutes before extubation, during extubation, and up to 10 minutes after extubation. Secondary measures are: oxygen saturation, respiratory rate, blood pressure, duration of the procedure, number of reintubations, and heart rate variability.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients hospitalized who are undergoing an extubation process.
Disqualifiers
Pediatric patients with accidental extubation will be excluded.
Trial design
Design model
Parallel
Treatments tested in this trial
Music therapy + standard care
Other interventionIn the pre-extubation and extubation phase, the musical characteristics will be based on a slow to medium tempo, simple harmonic structures (e.g., tonic-subdominant movements), fluid melodies, and avoiding large intervals or abrupt changes of tonalities. The musical instruments used will be a classical guitar with nylon strings (Yamaha C-40) and the voice of the music therapist without lyrics or words. In the post-extubation phase, the musical characteristics will be based on a moderate tempo, introducing chord progressions aiming at tension-resolution (e.g., dominant-tonic), and a more rhythmic application of melodic or harmonic material.
Standard Care (in control arm)
Other interventionStandard care during the extubation process involves providing usual the medical care provided for patients according to each hospital's guidelines.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Music therapy + standard careExperimental treatment 1 intervention
Group B: Standard careOther 1 intervention
Trial outcomes
Primary outcomes
1
Heart rate
It will be measured through pulse oximetry every minute.
Time frame
From 5 minutes pre-extubation to 10 minutes post-extubation.Secondary outcomes
1
Respiratory rate
It will be measured through pulse oximetry every minute.
Time frame
From 5 minutes pre-extubation to 10 minutes post-extubation.2
Oxygen saturation
It will be measured through pulse oximetry every minute.
Time frame
From 5 minutes pre-extubation to 10 minutes post-extubation.3
Blood pressure
Diastolic, systolic, and mean BP will be measured on the forearm with an age-appropriate cuff, at the level of the brachial artery in the right antecubital fossa, every 5 minutes.
Time frame
From 5 minutes pre-extubation to 10 minutes post-extubation.4
Heart rate variability
It will be measured with the electrocardiogram by standard monitoring.
Time frame
From 5 minutes pre-extubation to 10 minutes post-extubation.Sponsors and contacts
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Source ClinicalTrials.gov