Using Music During Lumbar Medial Branch Block Procedure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04091607|
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : October 2, 2019
|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"|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091607
|Contact: Carolyn Hendrickfirstname.lastname@example.org|
|Contact: Heather Columbano, MDemail@example.com|
|United States, North Carolina|
|Wake Forest University School of Medicine||Not yet recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Heather Columbano, MD||Wake Forest University Health Sciences|