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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04924244
Other study ID # 16112
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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