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Clinical Trials/NCT06235996
NCT06235996
Active, not recruiting
Not Applicable

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

Lake Erie College of Osteopathic Medicine1 site in 1 country100 target enrollmentJanuary 1, 2023
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Lake Erie College of Osteopathic Medicine
Enrollment
100
Locations
1
Primary Endpoint
VAS score
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Lake Erie College of Osteopathic Medicine
Responsible Party
Principal Investigator
Principal Investigator

Rebecca Steiner, Ph.D.

Principal Investigator

Lake Erie College of Osteopathic Medicine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Major hearing impairment
  • Sensitivity to music

Outcomes

Primary Outcomes

VAS score

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

Visual Analogue Scale (VAS) score

Blood pressure

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

Systolic and diastolic blood pressure

Biochemical marker of stress

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

Salivary cortisol levels

STAI score

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

State-Trait Anxiety Inventory (STAI) score

Heart rate

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

Heart rate

Study Sites (1)

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