An interventional study of Live entrained music therapy in Music Therapy, Pain and Allodynia, sponsored by Fundación Santa Fe de Bogota. Not yet recruiting at 1 site in Colombia. Open to participants aged 35 Weeks to 44 Weeks. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Fundación Santa Fe de Bogota · Not applicable, Interventional, and Treatment
Background: Hypoxic-ischemic encephalopathy (HIE) is a neurological condition caused by poor oxygenation during the peripartum period. The main strategy to mitigate neurological damage is hypothermic therapy (HT), whose effectiveness-among other factors-depends on adequate pain management. Considering the prevalence of allodynia in this group of patients, routine nursing procedures can become sources of additional stress and pain. Music therapy is used in this population to promote self-regulation and relaxation, and may therefore help reduce pain levels after routine nursing procedures.
Research question: What is the effect of an entrainment-based live music therapy intervention on pain levels in newborns with hypoxic-ischemic encephalopathy undergoing hypothermic therapy after routine nursing procedures? Methodology: A randomized, crossover pilot and feasibility study. Participants will be 22 newborns admitted to the Neonatal Intensive Care Unit (NICU) of the University Hospital Fundación Santa Fe de Bogotá. Participants will receive standard care plus a 15-minute live music therapy session after a routine nursing procedure, or standard care alone. The primary outcome is the Premature Infant Pain Profile-Revised (PIPP-R) scale, which will be assessed through video recordings. Secondary outcomes are vital signs, heart rate variability, and electroencephalography (EEG) recordings.
Expected outcomes: Through this study, the aim is to improve the comfort and well-being of patients with HIE during TH. In addition, the safety and feasibility of music therapy in this population will be evaluated, seeking to contribute to current knowledge about the mechanisms of music therapy.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 22 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Fundación Santa Fe de Bogota is the lead sponsor of 27 studies on the registry; 11 are open to participants now.
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- Neonates diagnosed with neonatal hypoxic ischemic encephalopathy who have undergone hypothermic therapy as part of their medical treatment.
Exclusion Criteria:
Live entrained music therapy
Behavioral: Live entrained music therapy
Standard care only
This study will use live, improvised, entrainment-based music. The music will be applied to synchronize with the newborns' breathing patterns, adapting the tempo to the breathing rate, with characteristics that seek to induce a state of relaxation in the patient: moderate volume (below 65 dB; this measure will be validated using the ambient noise indicator of the neonatal intensive care unit), simple harmonic sequences (tonic-subdominant-dominant), melodies that avoid large intervals (beyond a third), medium registers, and a stable pulse. Once the music therapist synchronizes the pulse of the music with the newborn's breathing, the music will be gradually become slower (approximately 10-15%), the volume will be adjusted, and the complexity of the music will be reduced until the patient can transition to a state of greater relaxation. The music therapy session will last 10 minutes, after which the music therapist will leave the room.
Premature Infant Pain Profile - Revised (PIPP-R)
The Premature Infant Pain Profile - Revised (PIPP-R) is a 10-item pain score used to assess pain in term and preterm infants. It consists of three indicators: physiological, e.g., heart rate and oxygen saturation; behavioral, e.g., facial expression; and contextual, e.g., gestational age. In the present study, for the behavioural part of the the PIPP-R we will use video recordings of the infant's face. Two raters will identify facial expressions associated with pain through one-minute video segments. The audio will be removed from the video, and measures will be taken to ensure that the music therapist does not appear in the recording, thus keeping the raters masked to the type of intervention.
Time frame: From start of the conditions to the end of the conditions, for about 30 minutes
Heart rate
Heart rate will be measured in beats per minute (BPM) and will be recorded continuously from 5 minutes before the routine nursing procedure, during the routine nursing procedure, during the music therapy intervention or the control condition, and up to 5 minutes after the intervention.
Time frame: From start of the conditions to the end of the conditions, for about 30 minutes.
Heart rate variability
Telemetry recordings will be used to obtain electrocardiographic time series. This measurement provides an estimate of sympathetic and vagal tone, which has been linked to the outcome of infants with HIE during HT.
Time frame: From start of the conditions to the end of the conditions, for about 30 minutes.
EEG - Electroencelography
Video telemetry recordings will be visually analyzed by the neurologist for patterns of seizure and abnormal activity; excessive discontinuities in the tracing, low voltage, or suppression of normal burst activity will be sought. These indicators correlate with the prognosis of the neonate with HIE during TH, the preservation of brain tissue, and the safety of the MT intervention.
Time frame: From start of the conditions to the end of the conditions, for about 30 minutes.
Oxygen saturation
Oxygen saturation will be measured in percentage (%) and will be recorded continuously from 5 minutes before the routine nursing procedure, during the routine nursing procedure, during the music therapy intervention or the control condition, and up to 5 minutes after the intervention.
Time frame: From start of the conditions to the end of the conditions, for about 30 minutes.
Respiratory Rate
Respiratory rate will be measured in numbers of respirations per minute and will be recorded continuously from 5 minutes before the routine nursing procedure, during the routine nursing procedure, during the music therapy intervention or the control condition, and up to 5 minutes after the intervention.
Time frame: From start of the conditions to the end of the conditions, for about 30 minutes.
Viability and safety measures
Number of events indicating hemodynamic instability or a negative change in vital signs during music therapy interventions and number of epileptic events during music therapy interventions. If music therapy sessions are discontinued in more than three patients, the study will be discontinued.
Time frame: From start of the conditions to the end of the conditions, for about 30 minutes.
Plan to share: Yes — Data will be available upon request
Supporting information: Study protocol
Time frame: data will be available after publication of the results
No publications or documents are linked to this record.
Start is estimated for Oct 2025; primary completion for Dec 2026, 14 months later.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 14 months is above that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Fundación Santa Fe de Bogota