The purpose of this study is to examine the feasibility and acceptability of listening to 20 minutes of preferred style of music twice-daily for 4 consecutive days on pain among 20 community-dwelling older adults with lower back pain (LBP)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The study will employ an individual receptive relaxation music method with participants selecting music based on their preference from a selection of various styles from the MUSIC CARE© app. The music intervention will last 20 minutes per session and will be administered twice daily for 4 consecutive days. Participants will be given an electronic tablet with the MUSIC CARE© app loaded on it and trained on how to access the app to select their preferred style of music.Participants will be instructed to use the provided headphone during all interventions and to sit in a quiet area while wearing an ocular mask to avoid distractions.The PI will remotely monitor each of the music intervention sessions in real-time monitoring via a secured video conferencing interface to ensure adherence to study protocol.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Enrollment rate: Assessed as number enrolled or number who met inclusion criteria
Time frame: 6 months from start of study
Attrition rate
Assessed as number not completing the study divided by number enrolled at baseline
Time frame: 6 months from start of study
Adherence rate
Assessed as number completing all measures divided by number enrolled
Time frame: 6 months from start of study
Treatment acceptability: Measured by the treatment acceptability and preference scale(TAP
Assess perceived acceptability of treatment using TAP in four categories of appropriateness, effectiveness, suitability, and willingness to adhere on a scale ranging from 0 (not at all) to 4 (very much).
Time frame: Baseline
Treatment acceptability: Measured by the treatment acceptability and preference scale(TAP)
Assess perceived acceptability of treatment using TAP in four categories of appropriateness, effectiveness, suitability, and willingness to adhere on a scale ranging from 0 (not at all) to 4 (very much).
Time frame: 5 days after baseline(1 day after completion of intervention)
Pain as measured by the numerical rating scale (NRS)
Self-reported mean clinical pain intensity defined as the average pain intensity experienced in the past 7 days will be measured using the 101-point NRS where 0 means no pain and 100 means worst imaginable pain.
Time frame: Baseline
Pain as measured by the numerical rating scale (NRS)
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Self-reported mean clinical pain intensity defined as the average pain intensity experienced in the past 24 hours will be measured using the 101-point NRS where 0 means no pain and 100 means worst imaginable pain.
Time frame: day 1
Pain as measured by the numerical rating scale (NRS)
Self-reported mean clinical pain intensity defined as the average pain intensity experienced in the past 24 hours will be measured using the 101-point NRS where 0 means no pain and 100 means worst imaginable pain.
Time frame: day 2
Pain as measured by the numerical rating scale (NRS)
Self-reported mean clinical pain intensity defined as the average pain intensity experienced in the past 24 hours will be measured using the 101-point NRS where 0 means no pain and 100 means worst imaginable pain.
Time frame: day 3
Pain as measured by the numerical rating scale (NRS)
Self-reported mean clinical pain intensity defined as the average pain intensity experienced in the past 24 hours will be measured using the 101-point NRS where 0 means no pain and 100 means worst imaginable pain.
Time frame: day 4
Pain as measured by the numerical rating scale (NRS)
Self-reported mean clinical pain intensity defined as the average pain intensity experienced in the past 24 hours will be measured using the 101-point NRS where 0 means no pain and 100 means worst imaginable pain.
Time frame: post intervention (day 5)
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form
The PROMIS Anxiety Short Form has 8 items with each item on the measure being rated on a 5-point scale (1-5) , a higher number indicating a worse outcome
Time frame: Baseline
Depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form
The PROMIS Depression Short Form has 8 items with each item on the measure being rated on a 5-point scale (1-5) , a higher number indicating a worse outcome
Time frame: Baseline
Change in brain activation in the motor and somatosensory cortex as measured by functional near-infrared spectroscopy (fNIRS)
Pain-related measure of hemodynamic response function will be measured during pressure pain stimulation using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm.
Time frame: Baseline and post-intervention (Day 5)
Change in conditioned pain modulation (CPM)
Conditioned pain modulation will measure the difference in pressure pain threshold before and after a painful "conditioning stimulus" is applied to test central pain inhibition. The conditioning stimulus will involve the immersion of one hand in a cold-water bath. The pressure pain tolerance will be evaluated following a conditioning stimulus condition
Time frame: Baseline and post-intervention (Day 5)
Change in heart rate variability (HRV)
Heart rate variability will be assessed as an indicates the sympathetic nervous system status using lead II arrangement with an MP160 Data Acquisition Systems (Biopac Systems, Inc., Goleta, CA, U.S.A.).
Time frame: Baseline and post-intervention (Day 5)