Trial Outcomes & Findings for Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants (NCT NCT04286269)

Last Updated: 2025-04-23

Results Overview

The Premature Infant Pain Profile (PIPP) is a pain scoring system assessing 7 indicators: observed change in heart rate, observed decrease in percent oxygen saturation; observed facial expressions of pain (brow bulge, eye squeeze, and naso-labial furrow); gestational age; and behavioral state. Clinicians rate each indicator on a scale from 0 to 3 using a set scoring system. Total scores range 0 to 21, with higher scores indicating greater pain.

Recruitment status

TERMINATED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

2 weeks

Results posted on

2025-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Participants in this group will be randomized to receive the intervention. Music Based Intervention: Participants assigned to MBI will receive a total of 1.5 hours of music intervention 5-6 sessions per week. Music will be alternating: 30 minutes on and 30 minutes off and will be played when the subject is awake to cue pacification and initiate the sleep process. Music will be delivered through headphones using an MP3 player.	Placebo Participants in this group will be randomized to receive a sham treatment. Sham Treatment: Participants assigned to the control group will have the same treatment as the MBI group, but with no sound played through the headphones.
Overall Study STARTED	14	14
Overall Study COMPLETED	7	9
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=14 Participants Participants in this group will be randomized to receive the intervention. Music Based Intervention: Participants assigned to MBI will receive a total of 1.5 hours of music intervention 5-6 sessions per week. Music will be alternating: 30 minutes on and 30 minutes off and will be played when the subject is awake to cue pacification and initiate the sleep process. Music will be delivered through headphones using an MP3 player.	Placebo n=14 Participants Participants in this group will be randomized to receive a sham treatment. Sham Treatment: Participants assigned to the control group will have the same treatment as the MBI group, but with no sound played through the headphones.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Participants in this group will be randomized to receive the intervention. Music Based Intervention: Participants assigned to MBI will receive a total of 1.5 hours of music intervention 5-6 sessions per week. Music will be alternating: 30 minutes on and 30 minutes off and will be played when the subject is awake to cue pacification and initiate the sleep process. Music will be delivered through headphones using an MP3 player.	Placebo n=13 Participants Participants in this group will be randomized to receive a sham treatment. Sham Treatment: Participants assigned to the control group will have the same treatment as the MBI group, but with no sound played through the headphones.
Premature Infant Pain Profile (PIPP) Score	6.8 unit in a scale Standard Deviation 3.6	7.8 unit in a scale Standard Deviation 3.7

PRIMARY outcome

Timeframe: 4 weeks

Population: .All other outcome measures besides 1 were considered separate. Each outcome measure had a different number of participants who completed that portion of the study. The ERP (Event Related Potential) measure only had one participant attend. Ultimately, the number of participants analyzed should be based on the first primary outcome measure of pain profile.

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants Participants in this group will be randomized to receive the intervention. Music Based Intervention: Participants assigned to MBI will receive a total of 1.5 hours of music intervention 5-6 sessions per week. Music will be alternating: 30 minutes on and 30 minutes off and will be played when the subject is awake to cue pacification and initiate the sleep process. Music will be delivered through headphones using an MP3 player.	Placebo n=9 Participants Participants in this group will be randomized to receive a sham treatment. Sham Treatment: Participants assigned to the control group will have the same treatment as the MBI group, but with no sound played through the headphones.
Premature Infant Pain Profile (PIPP) Score	6.3 unit in a scale Standard Deviation 2.7	6.4 unit in a scale Standard Deviation 3.5

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sonya Wang

University of Minnesota

Phone: 612-301-1454

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place