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

Not Applicable

Completed

• Conditions: Low Back Pain; Chronic Pain; Aging; Sleep
• Interventions: Behavioral: Music with Suggestion; Behavioral: Pain Information; Behavioral: Music

• Registration Number: NCT04785963
• Lead Sponsor: Baylor University

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.

Study Timeline

• Study Start: 2021-02-23
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-08
• Primary Completion: 2022-07-03
• Study Completion: 2023-05-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-30
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music with Suggestion	Music with Suggestion	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.
Music	Pain Information	Control group where participants will be provided recordings of pre-determined music
Pain Information	Music	Non-arts group receiving structured attention and standard care

Primary Outcome Measures

Name	Time	Method
Pain Intensity Scale	Daily	Subjective measures of pain intensity, which will be determined using a Pain Intensity Scale. This measure will be completed daily where participants will be asked to rate the intensity of their pain on a scale from 0 (No Pain) to 10 (Very Intense Pain). Higher scores will indicate greater pain intensity.

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form	Weekly up to 4 weeks	To measure sleep disturbance. This scale measures self-report 1) sleep quality, 2) sleep depth, and 3) restoration associated with sleep. This scale includes 8 items measured on a 5-point scale.
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety- Short Form	Weekly up to 4 weeks	To measure anxiety. This measure assesses self-reported fear, worry, dread, hyperarousal, and somatic symptoms related to arousal over the past 7 days on a 1 (never) to 5 (always) scale. This scale includes 8 items with higher scores indicating greater anxiety symptoms.
Self-report of medication use	Daily up to 4 weeks	Medication use measured by participants' daily self-report of medication use.
Relaxation Visual Analog Scale	Weekly up to 4 weeks	To measure relaxation. Participants will be asked to rate their level of relaxation on a scale from 0 (Not Relaxed at All) to 10 (Very Relaxed). Higher scores will indicate greater relaxation.
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form	Weekly up to 4 weeks	To measure depression. This measure assesses self-reported experiences of negative mood, decreased positive affect and decreased engagement over the past 7 days on a 1 (never) to 5 (always) scale. This scale includes 8 items with higher scores indicating greater depressive symptoms.
Pain Suffering Visual Analogue Scale (VAS)	Weekly up to 4 weeks	To measure pain suffering. Participants will be asked to rate their level of suffering from pain on a 0 (No Suffering) to 10 (Extreme Suffering) scale. Higher scores will indicate greater pain suffering.

Trial Locations

Locations (1)

Baylor University; 🇺🇸 Waco, Texas, United States