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

Pain Clinical Trial

Official title:

The Impact of Music Meditation Therapy on Pain, Mood, and Stress When Botulium Toxin (Botox) Injection is Utilized: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03532607
• Other study ID #: Pro2015000590
• Status: Recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: April 2020

Study information

• Verified date: October 2019
• Source: Rowan University
• Contact: Lauren Fedpr, CCRP
• Phone: 856-566-6003
• Email: fedor[@]rowan.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Music
Patients will listen to soothing music for 30 minutes before their standard of care botox injection

Locations

Country	Name	City	State
United States	Rowan University SOM NeuroMusculoskeletal Institute	Stratford	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rowan University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Visual Analogue Scale (VAS)	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.'	3 minutes
Secondary	Stress Visual Analogue Scale (VAS)	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.'	3 minutes
Secondary	Mood Visual Analogue Scale (VAS)	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.'	3 minutes