Intensive Care Pediatric, Respiratory Failure
Conditions
Keywords
vital signs, Pediatric Intensive Care Unit, extubation, music therapy, mechanical ventilation, hear rate
Brief summary
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.
Interventions
OTHERMusic therapy + standard care
In 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.
OTHERStandard Care (in control arm)
Standard care during the extubation process involves providing usual the medical care provided for patients according to each hospital's guidelines.
Sponsors
Sanitas University
Claudia Aristizábal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients hospitalized who are undergoing an extubation process.
Exclusion criteria
* Pediatric patients with accidental extubation will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | From 5 minutes pre-extubation to 10 minutes post-extubation. | It will be measured through pulse oximetry every minute. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate | From 5 minutes pre-extubation to 10 minutes post-extubation. | It will be measured through pulse oximetry every minute. |
| Oxygen saturation | From 5 minutes pre-extubation to 10 minutes post-extubation. | It will be measured through pulse oximetry every minute. |
| Blood pressure | From 5 minutes pre-extubation to 10 minutes post-extubation. | 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. |
| Heart rate variability | From 5 minutes pre-extubation to 10 minutes post-extubation. | It will be measured with the electrocardiogram by standard monitoring. |
Countries
Colombia
Contacts
Primary ContactMark Ettenberger, PhD
Backup ContactJohana Benavides Cruz, MSc
Outcome results
None listed