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

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Baylor University

Status

Completed

Conditions

Aging
Chronic Pain
Sleep
Low Back Pain

Treatments

Behavioral: Music
Behavioral: Music with Suggestion
Behavioral: Pain Information

Study type

Interventional

Funder types

Other

Identifiers

NCT04785963
1863320-38

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 3 patient groups

Music with Suggestion
Experimental group
Description:
Active condition where participants will be provided with recordings of pre-determined music in addition to recorded suggestions instructing the participant on how to listen to the music.
Treatment:
Behavioral: Music with Suggestion
Music
Active Comparator group
Description:
Control group where participants will be provided recordings of pre-determined music
Treatment:
Behavioral: Pain Information
Pain Information
Active Comparator group
Description:
Non-arts group receiving structured attention and standard care
Treatment:
Behavioral: Music

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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