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

NCT ID: NCT03532607

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2020-04-30

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Music

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music

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

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rowan University

OTHER

Sponsor Role: lead

Responsible Party

Richard Jermyn

Director, NeuroMusculoskeletal Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Jermyn, DO

Role: PRINCIPAL_INVESTIGATOR

Rowan University School of Osteopathic Medicine

Locations

Rowan University SOM NeuroMusculoskeletal Institute

Stratford, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lauren Fedpr, CCRP

Role: CONTACT

fedor@rowan.edu

856-566-6003

Facility Contacts

Richard S Jermyn, DO

Role: primary

jermynrt@rowan.edu

856-566-2305

Other Identifiers

Pro2015000590

Identifier Type: -

Identifier Source: org_study_id