Effect of Music on Pain and Anxiety in Chronic Pain Patients Undergoing Lumbar Interventional Procedures.

Anxiety Clinical Trial

Official title:

Effect of Music on Pain and Anxiety in Chronic Pain Patients Undergoing Lumbar Interventional Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04924244
• Other study ID #: 16112
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: Bunty Shah, MD
• Phone: 717-531-5680
• Email: bshah[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate, subjectively and objectively, whether playing music during procedures for treatment of chronic lower back pain has an effect on patients' anxiety and pain. The investigators hypothesize that playing music will result in reduced patient reported anxiety and pain scores and less variation from baseline of vital signs versus patients in the control group without music therapy. This is a pilot study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age greater than or equal to 18

2. Female or male

3. Patients undergoing standard of care lumbar spinal interventional procedures including: epidural steroid injections, facet injections, medial branch blocks

Exclusion Criteria:

1. Patients who cannot consent for themselves, including cognitively impaired patients.

2. Non-English speaking patients

3. Patients taking beta blocker medication

4. Patients that have a pacer and have a set rate

5. Patients with self-reported hearing problems or with hearing aids

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Chronic Pain

Intervention

Other:
• Music Therapy
We will play music of the subject's choice of genre during the procedure.
• No Music
No music will be played during the subject's interventional procedure

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-procedure State-Trait Anxiety Inventory (STAI) Score	A measure of anxiety in a person. Higher score correlates increased anxiety and worsened outcome. The minimum score is 40 and the maximum score is 160.	Within 30 minutes prior to the subject's interventional procedure
Primary	Post-procedure State-Trait Anxiety Inventory (STAI) Score	A measure of anxiety in a person. Higher score correlates with increased anxiety and worsened outcome. The minimum score is 40 and the maximum score is 160.	Within 30 minutes following to the subject's interventional procedure
Secondary	Pre-procedural Visual Analog Score (VAS) for pain	Visual Analog Score for pain. Higher score correlates with increased pain and worsened outcome. The minimum score is 0 and the maximum score is 10.	Within 30 minutes prior to the subject's interventional procedure
Secondary	Post procedural Visual Analog Score (VAS)	Visual Analog Score for pain. Higher score correlates with increased pain and worsened outcome. The minimum score is 0 and the maximum score is 10.	Within 30 minutes following the subject's interventional procedure