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

NCT06235996 | Active Not Recruiting

• 1 other identifier: 12345
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain

Keywords

Chronic pain; Pain management

Outcome Measures

Primary Outcomes (5)

• VAS score

  Visual Analogue Scale (VAS) score

  Immediately before and after an office-based procedure

• STAI score

  State-Trait Anxiety Inventory (STAI) score

  Immediately before and after an office-based procedure

• Blood pressure

  Systolic and diastolic blood pressure

  Immediately before and after an office-based procedure

• Heart rate

  Heart rate

  Immediately before and after an office-based procedure

• Biochemical marker of stress

  Salivary cortisol levels

  Immediately before and after an office-based procedure

Study Arms (2)

Music Intervention

EXPERIMENTAL

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.

Procedure: Office-based procedure indicated for chronic pain with music

Control

OTHER

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.

Procedure: Office-based procedure indicated for chronic pain without music

Interventions

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.

Music Intervention

Office-based procedure indicated for chronic pain without music PROCEDURE

Office-based procedure indicated for chronic pain without music

Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Major hearing impairment
• Sensitivity to music

Sponsors & Collaborators

• Lake Erie College of Osteopathic Medicine: lead

Study Sites (2)

NeuSpine Institute

Wesley Chapel, Florida, 33544, United States

Location

NeuSpine Institute

Zephyrhills, Florida, 33540, United States

Location

MeSH Terms

Conditions

Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Kamal Patel, MD

  NeuSpine Institute, Florida

  STUDY DIRECTOR

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: Principal Investigator

Model Details: Primary Purpose: Treatment Allocation: Randomized Interventional Model: Parallel Assignment Masking: Not applicable

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: February 1, 2024
• Study Start: January 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)