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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06235996
• Other study ID #: 12345
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2024
• Source: Lake Erie College of Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Major hearing impairment
• Sensitivity to music

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
United States	NeuSpine Institute	Wesley Chapel	Florida
United States	NeuSpine Institute	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Lake Erie College of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS score	Visual Analogue Scale (VAS) score	Immediately before and after an office-based procedure
Primary	STAI score	State-Trait Anxiety Inventory (STAI) score	Immediately before and after an office-based procedure
Primary	Blood pressure	Systolic and diastolic blood pressure	Immediately before and after an office-based procedure
Primary	Heart rate	Heart rate	Immediately before and after an office-based procedure
Primary	Biochemical marker of stress	Salivary cortisol levels	Immediately before and after an office-based procedure