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Effect of Music on Pain and Anxiety in Chronic Pain Patients Undergoing Lumbar Interventional Procedures.

Primary Purpose

Chronic Pain, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
No Music
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age greater than or equal to 18
  2. Female or male
  3. Patients undergoing standard of care lumbar spinal interventional procedures including: epidural steroid injections, facet injections, medial branch blocks

Exclusion Criteria:

  1. Patients who cannot consent for themselves, including cognitively impaired patients.
  2. Non-English speaking patients
  3. Patients taking beta blocker medication
  4. Patients that have a pacer and have a set rate
  5. Patients with self-reported hearing problems or with hearing aids

Sites / Locations

  • Milton S. Hershey Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No Music

Music Therapy

Arm Description

No music will be played during the subject's standard of care lumbar spinal interventional procedure (including: epidural steroid injections, facet injections, medial branch blocks).

Music of the subject's preferred genre will be played during the subject's standard of care lumbar spinal interventional procedure (including: epidural steroid injections, facet injections, medial branch blocks).

Outcomes

Primary Outcome Measures

Pre-procedure State-Trait Anxiety Inventory (STAI) Score
A measure of anxiety in a person. Higher score correlates increased anxiety and worsened outcome. The minimum score is 40 and the maximum score is 160.
Post-procedure State-Trait Anxiety Inventory (STAI) Score
A measure of anxiety in a person. Higher score correlates with increased anxiety and worsened outcome. The minimum score is 40 and the maximum score is 160.

Secondary Outcome Measures

Pre-procedural Visual Analog Score (VAS) for pain
Visual Analog Score for pain. Higher score correlates with increased pain and worsened outcome. The minimum score is 0 and the maximum score is 10.
Post procedural Visual Analog Score (VAS)
Visual Analog Score for pain. Higher score correlates with increased pain and worsened outcome. The minimum score is 0 and the maximum score is 10.

Full Information

First Posted
June 7, 2021
Last Updated
August 9, 2023
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04924244
Brief Title
Effect of Music on Pain and Anxiety in Chronic Pain Patients Undergoing Lumbar Interventional Procedures.
Official Title
Effect of Music on Pain and Anxiety in Chronic Pain Patients Undergoing Lumbar Interventional Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate, subjectively and objectively, whether playing music during procedures for treatment of chronic lower back pain has an effect on patients' anxiety and pain. The investigators hypothesize that playing music will result in reduced patient reported anxiety and pain scores and less variation from baseline of vital signs versus patients in the control group without music therapy. This is a pilot study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Music
Arm Type
Active Comparator
Arm Description
No music will be played during the subject's standard of care lumbar spinal interventional procedure (including: epidural steroid injections, facet injections, medial branch blocks).
Arm Title
Music Therapy
Arm Type
Experimental
Arm Description
Music of the subject's preferred genre will be played during the subject's standard of care lumbar spinal interventional procedure (including: epidural steroid injections, facet injections, medial branch blocks).
Intervention Type
Other
Intervention Name(s)
Music Therapy
Intervention Description
We will play music of the subject's choice of genre during the procedure.
Intervention Type
Other
Intervention Name(s)
No Music
Intervention Description
No music will be played during the subject's interventional procedure
Primary Outcome Measure Information:
Title
Pre-procedure State-Trait Anxiety Inventory (STAI) Score
Description
A measure of anxiety in a person. Higher score correlates increased anxiety and worsened outcome. The minimum score is 40 and the maximum score is 160.
Time Frame
Within 30 minutes prior to the subject's interventional procedure
Title
Post-procedure State-Trait Anxiety Inventory (STAI) Score
Description
A measure of anxiety in a person. Higher score correlates with increased anxiety and worsened outcome. The minimum score is 40 and the maximum score is 160.
Time Frame
Within 30 minutes following to the subject's interventional procedure
Secondary Outcome Measure Information:
Title
Pre-procedural Visual Analog Score (VAS) for pain
Description
Visual Analog Score for pain. Higher score correlates with increased pain and worsened outcome. The minimum score is 0 and the maximum score is 10.
Time Frame
Within 30 minutes prior to the subject's interventional procedure
Title
Post procedural Visual Analog Score (VAS)
Description
Visual Analog Score for pain. Higher score correlates with increased pain and worsened outcome. The minimum score is 0 and the maximum score is 10.
Time Frame
Within 30 minutes following the subject's interventional procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 18 Female or male Patients undergoing standard of care lumbar spinal interventional procedures including: epidural steroid injections, facet injections, medial branch blocks Exclusion Criteria: Patients who cannot consent for themselves, including cognitively impaired patients. Non-English speaking patients Patients taking beta blocker medication Patients that have a pacer and have a set rate Patients with self-reported hearing problems or with hearing aids
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bunty Shah, MD
Phone
717-531-5680
Email
bshah@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mrinal Agrawal, MD
Email
magrawal@pennstatehealth.psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bunty Shah
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bunty Shah, MD
Phone
717-531-5860
Email
bshah@pennstatehealth.psu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Music on Pain and Anxiety in Chronic Pain Patients Undergoing Lumbar Interventional Procedures.

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