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

Rowan University

Status: Unknown

Conditions: Pain

Treatments: Other: Music

Study type: Interventional

Funder types: Other

Identifiers

NCT03532607

Pro2015000590

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups

Treatment

Experimental group

Description:

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.

Treatment:

Other: Music

Control

No Intervention group

Description:

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.