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

NCT03532607 | Unknown

• 1 other identifier: Pro2015000590
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic

Outcome Measures

Primary Outcomes (1)

• 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.'

  3 minutes

Secondary Outcomes (2)

• Stress Visual Analogue Scale (VAS)

  3 minutes

• Mood Visual Analogue Scale (VAS)

  3 minutes

Study Arms (2)

Treatment

EXPERIMENTAL

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.

Other: Music

Control

NO INTERVENTION

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 OTHER

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

Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rowan University: lead

Study Sites (1)

Rowan University SOM NeuroMusculoskeletal Institute

Stratford, New Jersey, 08084, United States

RECRUITING

MeSH Terms

Conditions

Pain; Bronchiolitis Obliterans Syndrome

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Richard Jermyn, DO

  Rowan University School of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Fedpr, CCRP

CONTACT

856-566-6003; fedor@rowan.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, NeuroMusculoskeletal Institute

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: May 22, 2018
• Study Start: December 1, 2015
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

US (1)