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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Chronic Pain; Sleep; Aging
• Intervention / Treatment: Behavioral: Music with Suggestion; Behavioral: Pain Information; Behavioral: Music

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Waco, Texas, United States, 76798
      • Baylor University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Music with Suggestion; A 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.
Active Comparator: Music; Control group where participants will be provided recordings of pre-determined music	Behavioral: Pain Information; The 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.
Active Comparator: Pain Information; Non-arts group receiving structured attention and standard care	Behavioral: Music; The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity Scale	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.	Daily

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Suffering Visual Analogue Scale (VAS)	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.	Weekly up to 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form	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.	Weekly up to 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form	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.	Weekly up to 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety- Short Form	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.	Weekly up to 4 weeks
Relaxation Visual Analog Scale	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.	Weekly up to 4 weeks
Self-report of medication use	Medication use measured by participants' daily self-report of medication use.	Daily up to 4 weeks

Collaborators and Investigators

• Sponsor: Baylor University

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): July 3, 2022
• Study Completion (Actual): May 4, 2023

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 30, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: 1863320-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No