Trial Outcomes & Findings for Analgesic Effect of Music Listening During Pain Elicitation in Fibromyalgia (NCT NCT04059042)
NCT ID: NCT04059042
Last Updated: 2023-12-15
Results Overview
Pain threshold summation as measured by the quantitative sensory testing (QST) battery. Pain is rated subjectively on a 0-100 scale with 0 being no pain and 100 being the worst pain imaginable. Summation is calculated as the difference in pain score between a single stimulus and a series of 10 stimuli with larger values indicating more severe summation.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
1 week
Results posted on
2023-12-15
Participant Flow
Participant milestones
| Measure |
Music
The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (\~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear music.
The musical selections will be professional recordings of instrumental Classical music selected by the researcher. All participants will hear the same pieces in the same order. Instrumentation ranges from piano solo to full orchestra, but they are without lyrics or heavy percussion. Pitch ranges across the pieces, but is standard across participants and not controlled by either the participant or the researcher. Tempo for all of the pieces is slow (\~60 beats per minute). The pieces are in either major keys or minor keys, but all consist primarily of consonant harmonies and sustained melodic phrases. Participants will control the volume to their individual comfort level.
Music Listening: Participants will have pain threshold testing while listening to silence, music, or nature sounds.
|
Nature Sounds
The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (\~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear nature sounds.
Professional recordings of nature sounds selected by the researcher without added music will be used as the active placebo control condition. All participants will hear the same recording. This active control condition will allow for non-musical analgesic effects, such as distraction, to be controlled in the experimental design. Participants will control the volume to their individual comfort level.
Music Listening: Participants will have pain threshold testing while listening to silence, music, or nature sounds.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analgesic Effect of Music Listening During Pain Elicitation in Fibromyalgia
Baseline characteristics by cohort
| Measure |
Music
n=4 Participants
The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (\~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear music.
The musical selections will be professional recordings of instrumental Classical music selected by the researcher. All participants will hear the same pieces in the same order. Instrumentation ranges from piano solo to full orchestra, but they are without lyrics or heavy percussion. Pitch ranges across the pieces, but is standard across participants and not controlled by either the participant or the researcher. Tempo for all of the pieces is slow (\~60 beats per minute). The pieces are in either major keys or minor keys, but all consist primarily of consonant harmonies and sustained melodic phrases. Participants will control the volume to their individual comfort level.
Music Listening: Participants will have pain threshold testing while listening to silence, music, or nature sounds.
|
Nature Sounds
n=5 Participants
The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (\~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear nature sounds.
Professional recordings of nature sounds selected by the researcher without added music will be used as the active placebo control condition. All participants will hear the same recording. This active control condition will allow for non-musical analgesic effects, such as distraction, to be controlled in the experimental design. Participants will control the volume to their individual comfort level.
Music Listening: Participants will have pain threshold testing while listening to silence, music, or nature sounds.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.18 years
STANDARD_DEVIATION 13.86 • n=5 Participants
|
40.28 years
STANDARD_DEVIATION 9.93 • n=7 Participants
|
44.24 years
STANDARD_DEVIATION 11.97 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Dominant Hand - Right
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education
High school/GED
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education
Some College
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
Technical/Associate's degree
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
Bachelor's degree
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
Advanced/professional degree
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekPain threshold summation as measured by the quantitative sensory testing (QST) battery. Pain is rated subjectively on a 0-100 scale with 0 being no pain and 100 being the worst pain imaginable. Summation is calculated as the difference in pain score between a single stimulus and a series of 10 stimuli with larger values indicating more severe summation.
Outcome measures
| Measure |
Nature Sounds
n=5 Participants
The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (\~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear nature sounds.
Professional recordings of nature sounds selected by the researcher without added music will be used as the active placebo control condition. All participants will hear the same recording. This active control condition will allow for non-musical analgesic effects, such as distraction, to be controlled in the experimental design. Participants will control the volume to their individual comfort level.
Music Listening: Participants will have pain threshold testing while listening to silence, music, or nature sounds.
|
Music
n=4 Participants
The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (\~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear music.
The musical selections will be professional recordings of instrumental Classical music selected by the researcher. All participants will hear the same pieces in the same order. Instrumentation ranges from piano solo to full orchestra, but they are without lyrics or heavy percussion. Pitch ranges across the pieces, but is standard across participants and not controlled by either the participant or the researcher. Tempo for all of the pieces is slow (\~60 beats per minute). The pieces are in either major keys or minor keys, but all consist primarily of consonant harmonies and sustained melodic phrases. Participants will control the volume to their individual comfort level.
Music Listening: Participants will have pain threshold testing while listening to silence, music, or nature sounds.
|
|---|---|---|
|
Pain Threshold Summation
Audio
|
4.13 units on a 100 point scale
Standard Deviation 5.60
|
20.25 units on a 100 point scale
Standard Deviation 14.29
|
|
Pain Threshold Summation
Silence
|
9.40 units on a 100 point scale
Standard Deviation 7.44
|
20.17 units on a 100 point scale
Standard Deviation 13.14
|
PRIMARY outcome
Timeframe: 1 weekPain tolerance as measured by the quantitative sensory testing (QST) battery. Pain is rated subjectively on a 0-100 scale with 0 being no pain and 100 being the worst pain imaginable. Tolerance is the pressure (kg/cm2) at which participants rated pain in their non-dominant thumb at 70 out of 100.
Outcome measures
| Measure |
Nature Sounds
n=5 Participants
The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (\~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear nature sounds.
Professional recordings of nature sounds selected by the researcher without added music will be used as the active placebo control condition. All participants will hear the same recording. This active control condition will allow for non-musical analgesic effects, such as distraction, to be controlled in the experimental design. Participants will control the volume to their individual comfort level.
Music Listening: Participants will have pain threshold testing while listening to silence, music, or nature sounds.
|
Music
n=4 Participants
The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (\~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear music.
The musical selections will be professional recordings of instrumental Classical music selected by the researcher. All participants will hear the same pieces in the same order. Instrumentation ranges from piano solo to full orchestra, but they are without lyrics or heavy percussion. Pitch ranges across the pieces, but is standard across participants and not controlled by either the participant or the researcher. Tempo for all of the pieces is slow (\~60 beats per minute). The pieces are in either major keys or minor keys, but all consist primarily of consonant harmonies and sustained melodic phrases. Participants will control the volume to their individual comfort level.
Music Listening: Participants will have pain threshold testing while listening to silence, music, or nature sounds.
|
|---|---|---|
|
Pain Tolerance
Audio
|
5.17 kg/cm2
Standard Deviation 0.85
|
4.12 kg/cm2
Standard Deviation 1.02
|
|
Pain Tolerance
Silence
|
5.05 kg/cm2
Standard Deviation 0.94
|
4.18 kg/cm2
Standard Deviation 1.00
|
Adverse Events
Music
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nature Sounds
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Music
n=5 participants at risk
The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (\~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear music.
The musical selections will be professional recordings of instrumental Classical music selected by the researcher. All participants will hear the same pieces in the same order. Instrumentation ranges from piano solo to full orchestra, but they are without lyrics or heavy percussion. Pitch ranges across the pieces, but is standard across participants and not controlled by either the participant or the researcher. Tempo for all of the pieces is slow (\~60 beats per minute). The pieces are in either major keys or minor keys, but all consist primarily of consonant harmonies and sustained melodic phrases. Participants will control the volume to their individual comfort level.
Music Listening: Participants will have pain threshold testing while listening to silence, music, or nature sounds.
|
Nature Sounds
n=5 participants at risk
The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (\~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear nature sounds.
Professional recordings of nature sounds selected by the researcher without added music will be used as the active placebo control condition. All participants will hear the same recording. This active control condition will allow for non-musical analgesic effects, such as distraction, to be controlled in the experimental design. Participants will control the volume to their individual comfort level.
Music Listening: Participants will have pain threshold testing while listening to silence, music, or nature sounds.
|
|---|---|---|
|
Cardiac disorders
Incidental Finding
|
20.0%
1/5 • Number of events 1 • 1 week
|
0.00%
0/5 • 1 week
|
Additional Information
Dr. Rebecca Lepping
University of Kansas Medical Center
Phone: 913-588-0287
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place