Clinical trial NCT06235996: Effects of Musical Intervention on Patient Pain and Anxiety for Office-based Procedures
Official title: Effects of Musical Intervention on Patient Pain and Anxiety for Office-based Procedures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Pain management
Lead sponsor: Lake Erie College of Osteopathic Medicine
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Primary Purpose: Treatment Allocation: Randomized Interventional Model: Parallel Assignment Masking: Not applicable
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Major hearing impairment
* Sensitivity to music

Primary outcomes:
measure: VAS score
timeFrame: Immediately before and after an office-based procedure
measure: STAI score
timeFrame: Immediately before and after an office-based procedure
measure: Blood pressure
timeFrame: Immediately before and after an office-based procedure
measure: Heart rate
timeFrame: Immediately before and after an office-based procedure
measure: Biochemical marker of stress
timeFrame: Immediately before and after an office-based procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Wesley Chapel
country: United States
facility: NeuSpine Institute
state: Florida
city: Zephyrhills
country: United States
facility: NeuSpine Institute
state: Florida
Study officials:
affiliation: NeuSpine Institute, Florida
name: Kamal Patel, MD
role: STUDY_DIRECTOR
References: