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

Not Applicable

• Conditions: Pain
• Interventions: Other: Music

• Registration Number: NCT03532607
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-22
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-22
• Last Update Posted: 2019-10-23
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Music	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.

Primary Outcome Measures

Name	Time	Method
Pain Visual Analogue Scale (VAS)	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

Name	Time	Method
Stress Visual Analogue Scale (VAS)	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.'
Mood Visual Analogue Scale (VAS)	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.'

Trial Locations

Locations (1)

Rowan University SOM NeuroMusculoskeletal Institute; 🇺🇸 Stratford, New Jersey, United States