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The Effect of Music Meditation Therapy in Patients With Chronic Pain Receiving Botox

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ClinicalTrials.gov Identifier: NCT03532607
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Jermyn, Rowan University

Brief Summary:
The purpose of this pilot study is to examine the impact of music meditation therapy session on patients with chronic pain who are receiving Botox injections at a pain management center.

Condition or disease Intervention/treatment Phase
Pain Other: Music Not Applicable

Detailed Description:
This study is a randomized controlled trial (RCT) that employs a two-arm parallel-group design. Ninety-eight participants scheduled to receive a Botox injection will be randomly assigned to receive individual music meditation therapy intervention group or standard care control group before the participant's Botox injection. The study team will use an embedded mixed methods study that uses both quantitative and qualitative data. Qualitative data play a supporting role and are embedded within a larger RCT. The qualitative data will help the investigators better understand the patients' experience of the interventions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Impact of Music Meditation Therapy on Pain, Mood, and Stress When Botulium Toxin (Botox) Injection is Utilized: A Randomized Controlled Trial
Study Start Date : December 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Treatment
Participants will be asked to listen to pre-recorded music offered by the research team from an ipod for 30 minutes. After the 30 minutes have elapsed, the research staff will return and ask the patient to turn off the music. The patient then will be escorted to the clinic room to receive the botox injection.
Other: Music
Patients will listen to soothing music for 30 minutes before their standard of care botox injection

No Intervention: Control
After completing the consent form, the participants who are assigned to the control group will be asked to remain in the patient waiting area. The patient then will be escorted to the clinic room to receive the botox injection.



Primary Outcome Measures :
  1. Pain Visual Analogue Scale (VAS) [ Time Frame: 3 minutes ]
    The VAS is a 100-mm line, the length of which represents a continuum of an experience such as pain. Verbal descriptors mark the end of the continuum. The study team use the verbal descriptors 'no pain' and 'worst imaginable pain.'


Secondary Outcome Measures :
  1. Stress Visual Analogue Scale (VAS) [ Time Frame: 3 minutes ]
    The VAS is a 100-mm line, the length of which represents a continuum of an experience such as stress. Verbal descriptors mark the end of the continuum. The study team use the verbal descriptors 'no stress' and 'extreme stress.'

  2. Mood Visual Analogue Scale (VAS) [ Time Frame: 3 minutes ]
    The VAS is a 100-mm line, the length of which represents a continuum of an experience such as mood. Verbal descriptors mark the end of the continuum.The study team use the verbal descriptors 'best mood' and 'worst mood.'



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients of both genders ages 18-60 who have been referred for Botox injection for treatment of chronic pain at the Rowan SOM NeuroMusculoskeletal Institute. These patients will have a prior diagnosis made by their physicians necessitating treatment with Botox injections.
  • Patients who have previously received a Botox injection or patients receiving Botox injections for the first time can participate.

Exclusion Criteria:

  • Patients who cannot speak or understand English for informed consent and patient teaching
  • Patients with hearing impairment.
  • Pregnant women, children and/or minors, cognitively impaired patients or the elderly (above 60 years of age).

Information from the National Library of Medicine

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): NCT03532607


Contacts
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Contact: Lauren Fedpr, CCRP 856-566-6003 fedor@rowan.edu

Locations
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United States, New Jersey
Rowan University SOM NeuroMusculoskeletal Institute Recruiting
Stratford, New Jersey, United States, 08084
Contact: Richard S Jermyn, DO    856-566-2305    jermynrt@rowan.edu   
Principal Investigator: Richard Jermyn, DO         
Sponsors and Collaborators
Rowan University
Investigators
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Principal Investigator: Richard Jermyn, DO Rowan University School of Osteopathic Medicine

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Responsible Party: Richard Jermyn, Director, NeuroMusculoskeletal Institute, Rowan University
ClinicalTrials.gov Identifier: NCT03532607     History of Changes
Other Study ID Numbers: Pro2015000590
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

Keywords provided by Richard Jermyn, Rowan University:
Chronic