Using Music During Lumbar Medial Branch Block Procedure
|ClinicalTrials.gov Identifier: NCT04091607|
Recruitment Status : Active, not recruiting
First Posted : September 17, 2019
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lower Back Pain Lumbar Spondylosis||Other: Music Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Group 1 will listen to Music during the procedure. Group 2 will not hear any music during the procedure|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||An Evaluation of Pain, Anxiety, Desire for Repeat Procedure, and Satisfaction Utilizing Music Therapy for Chronic Low Back Pain Patients During Lumbar Medial Branch Blocks"|
|Actual Study Start Date :||November 15, 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Active Comparator: Music Therapy Intervention Group
listen to preferred choice of music during the Lumbar Medial Branch Block procedure.
Other: Music Therapy
Subject will listen to Music using provided ear buds or headphones.
No Intervention: Control Group
No music will be provided but will be provided earbuds. The sound environment will be standard for procedures by closing procedure room door and minimizing extraneous sounds.
- Pain Scores with True Visual Analog scale [ Time Frame: Day 1 Pre Procedure ]Score ranges from 0 to 10 with higher score denoting more pain.
- Pain Scores with True Visual Analog scale [ Time Frame: Day 1 Post Procedure ]Score ranges from 0 to 10 with higher score denoting more pain.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091607
|United States, North Carolina|
|Wake Forest University School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Heather Columbano, MD||Wake Forest University Health Sciences|