Respiratory FailureNCT06591533
The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process.
A study of Respiratory Failure and Intensive Care Pediatric, run by Claudia Aristizábal at 2 sites in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Respiratory Failure, Intensive Care Pediatric
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesColombia
- Study dates
- 1 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients hospitalized who are undergoing an extubation process.
Who cannot join
- Pediatric patients with accidental extubation will be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia2 sites, 2 recruiting
- Recruiting
Clínica Reina Sofia Pediátrica y Mujer
Bogotá, Bogota D.C., 110121
Mark Ettenberger, Phd, +57 3112847635, mark.ettenberger@gmx.at
Mark Ettenberger, Phd
- Recruiting
Clínica Infantil Santa María del Lago
Bogotá, Bogota D.C., 111051
Mark Ettenberger, Phd, +57 3112847635, mark.ettenberger@gmx.at
Cesar Zuluaga
About this study
Official title: The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process in the Pediatric Intensive Care Unit
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.
- Conditions
- Respiratory Failure, Intensive Care Pediatric
- Being tested
- Music therapy + standard care, Standard Care (in control arm)
- Keywords
- vital signs, Pediatric Intensive Care Unit, extubation, music therapy, mechanical ventilation, hear rate
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy + standard careOther
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.
Standard Care (in control arm)Other
Standard care during the extubation process involves providing usual the medical care provided for patients according to each hospital's guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy + standard care | Experimental | Not described Receives: Other: Music therapy + standard care |
| Standard care | Other | Not described Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
It will be measured through pulse oximetry every minute.
Measured: From 5 minutes pre-extubation to 10 minutes post-extubation.
Secondary outcomes (4)
Respiratory rate
It will be measured through pulse oximetry every minute.
Measured: From 5 minutes pre-extubation to 10 minutes post-extubation.
Oxygen saturation
It will be measured through pulse oximetry every minute.
Measured: From 5 minutes pre-extubation to 10 minutes post-extubation.
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.
Measured: From 5 minutes pre-extubation to 10 minutes post-extubation.
Heart rate variability
It will be measured with the electrocardiogram by standard monitoring.
Measured: From 5 minutes pre-extubation to 10 minutes post-extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claudia Aristizábal
- Sponsor type
- University, hospital or other
- Collaborators
- Sanitas University
- Responsible party
- Sponsor-investigator, Claudia Aristizábal, Sanitas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591533
- Sponsor's protocol ID
- INV-MT EXTUBACION
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beltran YM, Charum DP, Zuluaga CA, Vega MA, Benavides-Cruz J, Amarillo M, Canon E, Alvarez I, Ramirez-Moreno J, Paez L, Garzon MC, Calderon PD, Quintero TC, Moreno J, Ettenberger M. Effect of music therapy on vital signs and heart rate variability of paediatric patients during the extubation process in the paediatric intensive care unit: a multicentre randomised clinical trial protocol. BMJ Open. 2025 Nov 19;15(11):e098251. doi: 10.1136/bmjopen-2024-098251.
PubMed 41263836
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process in the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06591533
- Acronym / sponsor ID
- INV-MT EXTUBACION
- Conditions
- Respiratory Failure, Intensive Care Pediatric
- Keywords
- vital signs, Pediatric Intensive Care Unit, extubation, music therapy, mechanical ventilation, hear rate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Claudia AristizábalUniversity, hospital or other
- Collaborators
- Sanitas University
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music therapy + standard care | Experimental | Other: Music therapy + standard care |
| Standard care | Other | Other: Standard Care (in control arm) |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients hospitalized who are undergoing an extubation process.
Key exclusion criteria (1 listed)
- Pediatric patients with accidental extubation will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapy + standard careIn 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. | Other | Music therapy + standard care |
| Standard 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. | Other | Standard care |
Primary outcome
Heart rate
Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.
It will be measured through pulse oximetry every minute.
4 secondary outcomes
Respiratory rate
Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.
Oxygen saturation
Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.
Blood pressure
Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.
Heart rate variability
Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Derived from this study: PubMed 41263836Beltran YM, Charum DP, Zuluaga CA, Vega MA, Benavides-Cruz J, Amarillo M, Canon E, Alvarez I, Ramirez-Moreno J, Paez L, Garzon MC, Calderon PD, Quintero TC, Moreno J, Ettenberger M. Effect of music therapy on vital signs and heart rate variability of paediatric patients during the extubation process in the paediatric intensive care unit: a multicentre randomised clinical trial protocol. BMJ Open. 2025 Nov 19;15(11):e098251. doi: 10.1136/bmjopen-2024-098251.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Respiratory Failure and Intensive Care Pediatric, run by Claudia Aristizábal at 2 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Ettenberger, PhD (57 + 3112847635, mark.ettenberger@gmx.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06591533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.