Pain Clinical Trial
Official title:
Music Engagement for Non-Pharmacological Analgesia R21 AT001586-01
The purpose of this study is to determine whether engaging in music listening tasks can
reduce the perception of pain and provide nondrug pain relief.
Study hypotheses: 1) Performing a highly engaging listening task reduces psychophysiological
arousal to painful stimuli. 2) Psychophysiological arousal to painful stimuli is a function
of the complexity of the auditory signal. 3) Signal complexity and task difficulty interact
to produce the greatest engagement and maximum reduction in psychophysiological arousal to
painful stimuli.
Music therapy involves the use of music to promote, maintain, and restore physical and
mental health. Music analgesia is one aspect of music therapy focused on the reduction of
pain through the use of musical activities. This study will build upon music analgesia data
in the development of a new concept called music engagement. This concept is based on
constructivist theory, which presumes that the brain continuously constructs and revises a
model of reality. Pain is a constructed reality that may be prevented from being felt if a
person is actively engaged in constructing another perceptual experience. Music listening is
an activity that requires activation and integration of many complex cognitive and emotional
processes; therefore, being actively engaged in music listening can impede the construction
of pain if the listener can fully construct and sustain the music experience. This study
will determine whether engagement in and construction of a music listening experience can
reduce perceptions of pain.
This trial will comprise two studies and will require two days of participation. At study
start, participants will have electrodes placed on a finger on their non-dominant hand and
on other body parts to record skin conductance and electrical brain activity. Participants
will also wear a headset to have their pupil movement measured. Tone synthesis software will
be used to generate different tones. In Study 1, a familiar tune, selected by the
participant, will be played against a background of varying tones. Occasionally, notes of
the tune will be missing or displaced. Participants will be asked to identify the deviant
notes while receiving painful fingertip shocks; they will be instructed to focus on the task
and ignore the shocks. Study 1 will consist of three different conditions (easy, hard, and
no condition). In the easy condition, the background tones occur far from the pitch range of
the tune, making missing or displaced notes easy to detect. In the hard condition, the pitch
range of the background tones will be adjacent to that of the tune, making the tune
difficult to discern from the background tones. In the no task condition, participants will
hear the familiar tune with random background tones, but they will be instructed to pay no
attention to the tune or the tones.
Participants will report their pain experiences in both a retrospective report and a
concurrent report. For the retrospective report, participants will report the highest,
lowest, and average levels of pain experienced during the preceding block of trials. For the
concurrent report, participants will give both a report of the level of pain experienced
immediately following each shock episode. At each of the two sessions participants take part
in, there will be two sets of trial blocks, one with pain reports and one without. There
will be two blocks for each of the three music task conditions for a total of twelve blocks
per session. Within each block, sixteen 7- to 11-second shocks will be given.
In Study 2, participants will take part in two types of listening tasks, one with only tones
and one with both a tune and background tones. There will be three tasks in the tone
condition (no task, easy task, and hard task). In the no task condition, participants will
hear repeated tones; they will be instructed to pay no attention to the tones. In the easy
condition, the deviant tones will be easily detectable; in the hard condition, they will be
less detectable. During each condition, participants will receive painful fingertip shocks.
The second task condition is similar to Study 1; participants will listen to a familiar tune
with various tones in the background. Participants will be given fingertip shocks and will
be asked to identify deviant notes for both the easy and hard conditions. For the no task
condition, participants will be instructed to pay no attention to the tune or background
tones. Participants will not be required to report pain in this part of the study.
Participants will receive two blocks of trials for each of the six task conditions.
Fingertip shocks will vary in intensity with the interval between shocks varying between 7
and 11 seconds.
Pain self-reports (Study 1), deviant note detections, skin conductance, pupil dilation, and
electroencephalogram changes following stimulations will be used to assess participants.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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