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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06235996
Enrollment
100
Registered
2024-02-01
Start date
2023-01-01
Completion date
2025-12-31
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Chronic pain, Pain management

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.

Interventions

PROCEDUREOffice-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.

PROCEDUREOffice-based procedure indicated for chronic pain without music

Office-based procedure indicated for chronic pain without music

Sponsors

Lake Erie College of Osteopathic Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Major hearing impairment * Sensitivity to music

Design outcomes

Primary

MeasureTime frameDescription
VAS scoreImmediately before and after an office-based procedureVisual Analogue Scale (VAS) score
STAI scoreImmediately before and after an office-based procedureState-Trait Anxiety Inventory (STAI) score
Blood pressureImmediately before and after an office-based procedureSystolic and diastolic blood pressure
Heart rateImmediately before and after an office-based procedureHeart rate
Biochemical marker of stressImmediately before and after an office-based procedureSalivary cortisol levels

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026