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

NCT04785963 | Completed DMC

• 1 other identifier: 1863320-38
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Chronic Pain; Sleep; Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain Suffering Visual Analogue Scale (VAS)

  Weekly up to 4 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form

  Weekly up to 4 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form

  Weekly up to 4 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety- Short Form

  Weekly up to 4 weeks

• Relaxation Visual Analog Scale

  Weekly up to 4 weeks

Study Arms (3)

Music with Suggestion

EXPERIMENTAL

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

Music

ACTIVE COMPARATOR

Control group where participants will be provided recordings of pre-determined music

Behavioral: Pain Information

Pain Information

ACTIVE COMPARATOR

Non-arts group receiving structured attention and standard care

Behavioral: Music

Interventions

Music with Suggestion BEHAVIORAL

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.

Music with Suggestion

Pain Information BEHAVIORAL

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.

Music

Music BEHAVIORAL

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.

Pain Information

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be at least 50 years of age
• 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
• Duration of pain must be ≥ 6 months
• Participant must be proficient and able to speak, read, and write in English
• 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

You may not qualify if:

• 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
• History of mental illness (i.e., psychosis, schizophrenia)
• Non-English speaker
• Pain classified as neuropathic as detected by the Pain Detect Questionnaire

Sponsors & Collaborators

• Baylor University: lead

Study Sites (1)

Baylor University

Waco, Texas, 76798, United States

Location

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Interventions

Suggestion; Music Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Sensory Art Therapies; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Mind-Body Medicine Research Lab

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 8, 2021
• Study Start: February 23, 2021
• Primary Completion: July 3, 2022
• Study Completion: May 4, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)