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OpenTrials
Completed

NCT Number: NCT04924244

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

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.

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Key information

Conditions

Chronic Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Therapy

Other

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

no music

Other

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

Primary outcomes

  1. Pre-procedure State-Trait Anxiety Inventory (STAI) Score

    Time frame: 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.

  2. Post-procedure State-Trait Anxiety Inventory (STAI) Score

    Time frame: 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 outcomes

  1. Pre-procedural Visual Analog Score (VAS) for pain

    Time frame: 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.

  2. Post procedural Visual Analog Score (VAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2021
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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