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

Not Applicable

Recruiting

• Conditions: Chronic Pain; Anxiety
• Interventions: Other: No Music; Other: Music Therapy

• Registration Number: NCT04924244
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-11
• Study Start: 2021-07-15
• Status Verified: 2024-09
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Music	No Music	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 Therapy	Music Therapy	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).

Primary Outcome Measures

Name	Time	Method
Pre-procedure State-Trait Anxiety Inventory (STAI) Score	Within 30 minutes prior to the subject's interventional procedure	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	Within 30 minutes following to the subject's interventional procedure	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

Name	Time	Method
Pre-procedural Visual Analog Score (VAS) for pain	Within 30 minutes prior to the subject's interventional procedure	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)	Within 30 minutes following the subject's interventional procedure	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.

Trial Locations

Locations (1)

Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States