The Effect of Music Therapy on Pain Levels in Neonates With Hypoxic-ischemic Encephalopathy During Hypothermia: a Randomized Pilot and Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Premature Infant Pain Profile - Revised (PIPP-R)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Main outcome measure will be evaluated through video analysis. The camera will be focused on the infant without the music therapist being in the frame. The sound will be muted.
Eligibility Criteria
- Ages
- 35 Weeks to 44 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Neonates diagnosed with neonatal hypoxic ischemic encephalopathy who have undergone hypothermic therapy as part of their medical treatment.
Exclusion Criteria
- •Newborns with a gestational age of less than 35 weeks and a birth weight of less than 1800 grams.
- •Newborns in palliative care or with congenital anomalies with a poor prognosis will also be excluded, as will those with preexisting neurological or genetic conditions.
- •Furthermore, newborns with a history of serious medical complications that may influence participation in the study, such as pulmonary hypertension or secondary seizure syndrome, will be considered ineligible.
- •Finally, patients with an N-PASS score of less than -2 will be excluded.
Arms & Interventions
Music therapy condition
Live entrained music therapy
Intervention: Live entrained music therapy (Behavioral)
Control condition
Standard care only
Outcomes
Primary Outcomes
Premature Infant Pain Profile - Revised (PIPP-R)
Time Frame: From start of the conditions to the end of the conditions, for about 30 minutes
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.
Secondary Outcomes
- Heart rate(From start of the conditions to the end of the conditions, for about 30 minutes.)
- Heart rate variability(From start of the conditions to the end of the conditions, for about 30 minutes.)
- EEG - Electroencelography(From start of the conditions to the end of the conditions, for about 30 minutes.)
- Oxygen saturation(From start of the conditions to the end of the conditions, for about 30 minutes.)
- Respiratory Rate(From start of the conditions to the end of the conditions, for about 30 minutes.)
- Heart rate(From start of the conditions to the end of the conditions, for about 30 minutes.)
- Heart rate variability(From start of the conditions to the end of the conditions, for about 30 minutes.)
- EEG - Electroencelography(From start of the conditions to the end of the conditions, for about 30 minutes.)
- Oxygen saturation(From start of the conditions to the end of the conditions, for about 30 minutes.)
- Respiratory Rate(From start of the conditions to the end of the conditions, for about 30 minutes.)
Investigators
Mark Ettenberger
Principal Investigator, Music Therapy Service FSFB
Fundación Santa Fe de Bogota