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

Primary Purpose

Low Back Pain, Chronic Pain, Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music with Suggestion
Pain Information
Music
Sponsored by
Baylor University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Low Back Pain

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Baylor University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Music with Suggestion

Music

Pain Information

Arm 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.

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

Non-arts group receiving structured attention and standard care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Self-report of medication use
Medication use measured by participants' daily self-report of medication use.

Full Information

First Posted
February 25, 2021
Last Updated
July 30, 2023
Sponsor
Baylor University
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1. Study Identification

Unique Protocol Identification Number
NCT04785963
Brief Title
Effect of Music and Other Audio Recordings for Chronic Pain in Aging Adults
Official Title
Effect of Music and Other Audio Recordings for Chronic Pain in Aging Adults: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
July 3, 2022 (Actual)
Study Completion Date
May 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Chronic Pain, Sleep, Aging

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music with Suggestion
Arm Type
Experimental
Arm 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.
Arm Title
Music
Arm Type
Active Comparator
Arm Description
Control group where participants will be provided recordings of pre-determined music
Arm Title
Pain Information
Arm Type
Active Comparator
Arm Description
Non-arts group receiving structured attention and standard care
Intervention Type
Behavioral
Intervention Name(s)
Music with Suggestion
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pain Information
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Music
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity Scale
Description
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.
Time Frame
Daily
Secondary Outcome Measure Information:
Title
Pain Suffering Visual Analogue Scale (VAS)
Description
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.
Time Frame
Weekly up to 4 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form
Description
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.
Time Frame
Weekly up to 4 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form
Description
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.
Time Frame
Weekly up to 4 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety- Short Form
Description
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.
Time Frame
Weekly up to 4 weeks
Title
Relaxation Visual Analog Scale
Description
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.
Time Frame
Weekly up to 4 weeks
Title
Self-report of medication use
Description
Medication use measured by participants' daily self-report of medication use.
Time Frame
Daily up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Baylor University
City
Waco
State/Province
Texas
ZIP/Postal Code
76798
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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