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NCT Number: NCT06235996

Effects of Musical Intervention on Patient Pain and Anxiety for Office-based Procedures

The purpose of this study is to determine if the use of musical intervention reduces patient anxiety and provides a less painful experience during office-based procedures in a pain management clinic setting.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NeuSpine Institute, Wesley Chapel, Florida, United States

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About this study

100 patients who are scheduled for interventional procedures will be randomly assigned to either a music intervention group or a no-music group. Such interventional procedures include sacroiliac joint (SI) steroidal injections, SI radiofrequency ablations, peripheral nerve stimulator implantations, caudal and laminar epidural steroidal injections, lumbar medial branch blocks, lumbar medial branch nerve radiofrequency ablations, spinal cord implantation of electro stimulators. These procedures are fluoroscopically guided. Each group will consist of 50 participants. Participants in the music intervention group will listen to their preferred genre of music during their procedure. The study participants in the music intervention group will listen to music via external speakers played in the procedure room. The music will not be loud enough to disrupt the physician's communication with the patient. The no-music group will receive the same treatment throughout the procedure; however, this group will not listen to music at any time during the procedure. To ensure acute pain and anxiety control, participants in both groups will receive standard analgesic treatment in the beginning of their scheduled interventional procedure. Such treatment includes injection and topical application of lidocaine to induce local anesthesia. The patients in both groups will complete a questionnaire that contains VAS and STAI scoring metrics to measure pain and anxiety levels, respectively. This questionnaire will be completed before and immediately after the procedure. Furthermore, we will use salivary cortisol as a non-subjective biomarker of psychological stress in study subjects not undergoing corticosteroid injections. The saliva samples from the study participants will be collected before and after their scheduled office-based procedures. Upon collection of saliva samples from the study participants, the samples will be picked up by the LabCorp, which then will perform salivary cortisol testing; the results will be reported to the study team.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Scheduled office-based procedure
  • Informed consent is signed by a subject

Exclusion criteria

  • Major hearing impairment
  • Sensitivity to music

Treatment and study plan

Office-based procedure indicated for chronic pain with music

Procedure

Such procedure may include sacroiliac joint (SI) steroidal injections, SI radiofrequency ablations, peripheral nerve stimulator implantations, caudal and laminar epidural steroidal injections, lumbar medial branch blocks, lumbar medial branch nerve radiofrequency ablations, spinal cord implantation of electro stimulators.

Office-based procedure indicated for chronic pain without music

Procedure

Office-based procedure indicated for chronic pain without music

Primary outcomes

  1. VAS score

    Time frame: Immediately before and after an office-based procedure

    Visual Analogue Scale (VAS) score

  2. STAI score

    Time frame: Immediately before and after an office-based procedure

    State-Trait Anxiety Inventory (STAI) score

  3. Blood pressure

    Time frame: Immediately before and after an office-based procedure

    Systolic and diastolic blood pressure

  4. Heart rate

    Time frame: Immediately before and after an office-based procedure

    Heart rate

  5. Biochemical marker of stress

    Time frame: Immediately before and after an office-based procedure

    Salivary cortisol levels

Sponsors and collaborators

Lead sponsor

Lake Erie College of Osteopathic Medicine

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Feb 1, 2024
Registry last updated
Mar 17, 2025

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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