Pain
Conditions
Keywords
Chronic
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.
Interventions
OTHERMusic
Patients will listen to soothing music for 30 minutes before their standard of care botox injection
Sponsors
Rowan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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.' |
Countries
United States
Contacts
Primary ContactLauren Fedpr, CCRP
Outcome results
None listed