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

Rowan University98 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Pain

Interventions

MusicOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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).

Locations (1)

Rowan University SOM NeuroMusculoskeletal Institute

Stratford, New Jersey, United States

RECRUITING

Outcomes

Primary Outcomes

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.'

Time frame: 3 minutes

Secondary Outcomes

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.'

Time frame: 3 minutes

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.'

Time frame: 3 minutes

Central Contacts

Lauren Fedpr, CCRP

CONTACT

856-566-6003 fedor@rowan.edu

Data from ClinicalTrials.gov

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