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

NCT ID: NCT06235996

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Music Intervention

A patient is scheduled for an office-based procedure such as a nerve block, epidural steroid injection, etc. Music-of-choice during the office-based procedure intervention is assigned to this group. Music via external speakers played in the procedure room. To ensure acute pain and anxiety control, participants 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. Standard of care is applied.

Group Type: EXPERIMENTAL

Office-based procedure indicated for chronic pain with music

Intervention Type: 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.

Control

A patient is scheduled for an office-based procedure such as a nerve block, epidural steroid injection, etc. No music intervention is assigned to this group. No music at any time during the procedure. To ensure acute pain and anxiety control, participants 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. Standard of care is applied.

Group Type: OTHER

Office-based procedure indicated for chronic pain without music

Intervention Type: PROCEDURE

Office-based procedure indicated for chronic pain without music

Interventions

Office-based procedure indicated for chronic pain with music

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.

Intervention Type: PROCEDURE

Office-based procedure indicated for chronic pain without music

Office-based procedure indicated for chronic pain without music

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Major hearing impairment
• Sensitivity to music

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lake Erie College of Osteopathic Medicine

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Steiner, Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamal Patel, MD

Role: STUDY_DIRECTOR

NeuSpine Institute, Florida

Locations

NeuSpine Institute

Wesley Chapel, Florida, United States

NeuSpine Institute

Zephyrhills, Florida, United States

Countries

United States

Other Identifiers

12345

Identifier Type: -

Identifier Source: org_study_id