Clinical trial NCT04785963: Effect of Music and Other Audio Recordings for Chronic Pain in Aging Adults
Official title: Effect of Music and Other Audio Recordings for Chronic Pain in Aging Adults: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Chronic Pain
Sleep
Aging
Lead sponsor: Baylor University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 66
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The long-range goal is to reduce suffering and establish alternative options for older adults experiencing pain. This is a randomized controlled study examining the effect of music on pain management in older adults.

Detailed description: Study Objectives:

1. Evaluate the efficacy of the music with suggestion intervention for chronic lower back pain in aging adults, with the indication that music with suggestion will significantly decrease subjective measures of pain compared to controls of music without suggestion or an informational recording about chronic pain.
2. Evaluate the efficacy of the music with suggestion intervention for sleep in aging adults, with the indication that music with suggestion will significantly improve subjective measures of sleep compared to controls of music without suggestion or an informational recording about chronic pain.
3. Evaluate the efficacy of the music with suggestion intervention for mood in aging adults, with the indication that music with suggestion will significantly improve subjective measures of mood compared to controls of music without suggestion or an informational recording about chronic pain.

Recruitment Plan

There will be 66 participants who wish to utilize mind-body interventions as treatment for chronic lower back pain.

The individual's eligibility will be determined using an Inclusion/Exclusion Criteria Screening Checklist containing the criteria listed above. If an individual appears to be eligible, he/she will be educated about the study purpose, procedures, and requirements. If the individual is interested in participating, they will sign a consent form, which may be signed through mail, through electronic platforms such as DocuSign, or in-person. The participant will be scheduled for their first formal education session and informed consent will take place during this session. This education session will take place through a video conference platform. All three groups will meet with a research staff member approximately five times (once during the education session and approximately once per week each following week) throughout the duration of the study. These sessions will take place through a video conference platform.

Eligibility criteria: Inclusion Criteria:

1. Participant must be at least 50 years of age
2. Participant must regularly experience moderate to severe chronic, lower back pain as determined by a self-reported pain rating of ≥ 5 on 11-point numerical rating scale
3. Duration of pain must be ≥ 6 months
4. Participant must be proficient and able to speak, read, and write in English
5. Participant must have access to a computer or mobile device, Internet, and be willing to participate in virtual sessions and use electronic platforms to complete materials

Exclusion Criteria:

1. Presence of any psychiatric condition or symptom that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking
2. History of mental illness (i.e., psychosis, schizophrenia)
3. Non-English speaker
4. Pain classified as neuropathic as detected by the Pain Detect Questionnaire

Primary outcomes:
measure: Pain Intensity Scale
timeFrame: Daily
Secondary outcomes:
measure: Pain Suffering Visual Analogue Scale (VAS)
timeFrame: Weekly up to 4 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form
timeFrame: Weekly up to 4 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form
timeFrame: Weekly up to 4 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety- Short Form
timeFrame: Weekly up to 4 weeks
measure: Relaxation Visual Analog Scale
timeFrame: Weekly up to 4 weeks
measure: Self-report of medication use
timeFrame: Daily up to 4 weeks
Other outcomes:
Locations:
city: Waco
country: United States
facility: Baylor University
state: Texas
Study officials:
References: