Clinical Trials Directory

Trials / Completed

CompletedNCT04785963

Effect of Music and Other Audio Recordings for Chronic Pain in Aging Adults

Effect of Music and Other Audio Recordings for Chronic Pain in Aging Adults: A Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
66 (actual)
Sponsor
Baylor University · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMusic with SuggestionA nonpharmacological, short-term treatment that poses minimal risk and places very limited burden on patients seems ideal for this population, and music with suggestions is one such treatment option.
BEHAVIORALPain InformationThe comparison condition of informational recordings about chronic pain are structured to account for non-specific effects of general time and attention and to evaluate whether the treatments of music alone, and music in combination with suggestion are effective in the reduction of pain intensity more than an appropriate control group.
BEHAVIORALMusicThe comparison condition of the music only is structured to account for the effect of music listening, and to evaluate whether the addition of suggestion optimizes its effectiveness in the reduction of pain intensity.

Timeline

Start date
2021-02-23
Primary completion
2022-07-03
Completion
2023-05-04
First posted
2021-03-08
Last updated
2023-08-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04785963. Inclusion in this directory is not an endorsement.