Trial Outcomes & Findings for Active and Passive Music Therapy Interventions (NCT NCT03362944)
NCT ID: NCT03362944
Last Updated: 2019-06-05
Results Overview
Five minute heart-rate variability (HRV) recordings will be taken before and after each intervention session through two electrodes placed on the participant's right collarbone and left rib cage. The recordings will be analyzed for HF and LF/HF components, which correspond with sympathetic and parasympathetic autonomic nervous system (ANS) activity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Before and after 40-minute intervention
Results posted on
2019-06-05
Participant Flow
No participants were excluded from the study prior to assignment to groups.
Participant milestones
| Measure |
Active Music Therapy Followed by Passive Music Therapy
Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
Interventions were spaced at minimum one week apart.
|
Passive Music Therapy Followed by Active Music Therapy
Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
Interventions were spaced at minimum one week apart.
|
|---|---|---|
|
First Intervention
STARTED
|
8
|
8
|
|
First Intervention
COMPLETED
|
8
|
8
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Single Week Washout Period
STARTED
|
8
|
8
|
|
Single Week Washout Period
COMPLETED
|
8
|
8
|
|
Single Week Washout Period
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
8
|
8
|
|
Second Intervention
COMPLETED
|
8
|
8
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study
n=16 Participants
Includes all participants in both treatment arms:
* Active Music Therapy followed by Passive Music Therapy
* Passive Music Therapy followed by Active Music Therapy
Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
For each arm interventions were spaced at minimum one week apart.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=16 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Before and after 40-minute interventionFive minute heart-rate variability (HRV) recordings will be taken before and after each intervention session through two electrodes placed on the participant's right collarbone and left rib cage. The recordings will be analyzed for HF and LF/HF components, which correspond with sympathetic and parasympathetic autonomic nervous system (ANS) activity.
Outcome measures
| Measure |
Active Music Therapy
n=16 Participants
Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
|
Passive Music Therapy
n=16 Participants
Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
|
|---|---|---|
|
Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude
HF power
|
0.1796 Decibels
Standard Deviation 1.6943
|
0.1507 Decibels
Standard Deviation 0.7360
|
|
Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude
LF/HF power
|
-0.3872 Decibels
Standard Deviation 0.6961
|
0.3731 Decibels
Standard Deviation 0.7693
|
PRIMARY outcome
Timeframe: Before and after 40-minute interventionStress hormone levels correspond with hypothalamic-pituitary-adrenal (HPA) axis activity. This will be assessed using saliva swabs.
Outcome measures
| Measure |
Active Music Therapy
n=16 Participants
Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
|
Passive Music Therapy
n=16 Participants
Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
|
|---|---|---|
|
Change From Baseline to Post Intervention Cortisol
|
-0.0496 Micrograms per deciliter
Standard Deviation 0.0949
|
-0.0174 Micrograms per deciliter
Standard Deviation 0.0558
|
PRIMARY outcome
Timeframe: Before and after 40-minute interventionStress hormone levels correspond with HPA axis activity. This will be assessed using saliva swabs.
Outcome measures
| Measure |
Active Music Therapy
n=16 Participants
Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
|
Passive Music Therapy
n=16 Participants
Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
|
|---|---|---|
|
Change From Baseline to Post Intervention Alpha-amylase (A-amylase)
|
-19.0285 units per milliliter
Standard Deviation 52.2087
|
-3.9287 units per milliliter
Standard Deviation 32.8864
|
SECONDARY outcome
Timeframe: Interventions are administered 1 week apart, post intervention recordings will be taken and compared on a 1 week time frame.Post intervention HRV recordings, assessed through two electrodes placed on the participant's right collarbone and left rib cage, will be compared between the Active and Passive intervention conditions.
Outcome measures
| Measure |
Active Music Therapy
n=16 Participants
Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
|
Passive Music Therapy
n=16 Participants
Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
|
|---|---|---|
|
Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude
HF power
|
1826 Decibels
Standard Deviation 1723
|
1220 Decibels
Standard Deviation 877.0
|
|
Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude
LF/HF power
|
1.344 Decibels
Standard Deviation 1.141
|
1.753 Decibels
Standard Deviation 1.459
|
SECONDARY outcome
Timeframe: Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions.
Outcome measures
| Measure |
Active Music Therapy
n=16 Participants
Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
|
Passive Music Therapy
n=16 Participants
Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
|
|---|---|---|
|
Active and Passive Music Therapy Post Intervention Cortisol
|
.1784 micrograms per deciliter
Standard Deviation .0884
|
.1839 micrograms per deciliter
Standard Deviation .0902
|
SECONDARY outcome
Timeframe: Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions.
Outcome measures
| Measure |
Active Music Therapy
n=16 Participants
Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
|
Passive Music Therapy
n=16 Participants
Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
|
|---|---|---|
|
Active and Passive Music Therapy Post Intervention A-amylase
|
75.02 Units per milliliter
Standard Deviation 62.87
|
57.31 Units per milliliter
Standard Deviation 45.31
|
Adverse Events
Active Music Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Passive Music Therapy
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
Trevor McPherson
Frohlich Lab - University of North Carolina at Chapel HIll
Phone: 919-966-4755
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place