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

NCT04924244 | Recruiting

• 1 other identifier: 16112
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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.

  Within 30 minutes prior to the subject's interventional procedure

• 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.

  Within 30 minutes following to the subject's interventional procedure

Secondary Outcomes (2)

• Pre-procedural Visual Analog Score (VAS) for pain

  Within 30 minutes prior to the subject's interventional procedure

• Post procedural Visual Analog Score (VAS)

  Within 30 minutes following the subject's interventional procedure

Study Arms (2)

No Music

ACTIVE COMPARATOR

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).

Other: No Music

Music Therapy

EXPERIMENTAL

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).

Other: Music Therapy

Interventions

Music Therapy OTHER

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

Music Therapy

No Music OTHER

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

No Music

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bunty Shah

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bunty Shah, MD

CONTACT

717-531-5680; bshah@pennstatehealth.psu.edu

Mrinal Agrawal, MD

CONTACT

magrawal@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology & Perioperative Medicine

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 11, 2021
• Study Start: July 15, 2021
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: January 30, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)