Recruiting

Music Meditation Therapy with Botox

Sponsor:

Rowan University

Code:

NCT03532607

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Music

Study Details

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.

Conditions

Pain

Study ID

NCT03532607

Start date

Dec, 2015

Status verified date

Oct, 2019

Completion date

Apr, 2020

Anticipated

Primary completion date

Apr, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

Interventions

Music

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

Primary outcome measure

  • Pain Visual Analogue Scale (VAS) [ Time Frame: 3 minutes ]

Central Contacts and Locations

Central contacts

Locations

Rowan University SOM NeuroMusculoskeletal Institute

Recruiting

Stratford, New Jersey, United States, 08084

Contacts

Principal Investigator:

Richard Jermyn, DO

More Information

Sponsor

Rowan University

Last update posted

Oct 23, 2019

Last verified

Oct, 2019

Keywords

  • Chronic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rowan University on 2019-10-23.