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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04924244
Enrollment
30
Registered
2021-06-11
Start date
2021-07-15
Completion date
2026-03-23
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Chronic Pain

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.

Interventions

OTHERMusic Therapy

We will play music of the subject's choice of genre during the procedure.

OTHERNo Music

No music will be played during the subject's interventional procedure

Sponsors

Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pre-procedure State-Trait Anxiety Inventory (STAI) ScoreWithin 30 minutes prior to the subject's interventional procedureA 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) ScoreWithin 30 minutes following to the subject's interventional procedureA 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

MeasureTime frameDescription
Pre-procedural Visual Analog Score (VAS) for painWithin 30 minutes prior to the subject's interventional procedureVisual 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 procedureVisual Analog Score for pain. Higher score correlates with increased pain and worsened outcome. The minimum score is 0 and the maximum score is 10.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBunty Shah

Milton S. Hershey Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026