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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music | Other | Patients will listen to soothing music for 30 minutes before their standard of care botox injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stress Visual Analogue Scale (VAS) | 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.' | 3 minutes |
| Mood Visual Analogue Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Fedpr, CCRP | Contact | 856-566-6003 | fedor@rowan.edu |
| Name | Affiliation | Role |
|---|---|---|
| Richard Jermyn, DO | Rowan University School of Osteopathic Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rowan University SOM NeuroMusculoskeletal Institute | Recruiting | Stratford | New Jersey | 08084 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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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.' |
| 3 minutes |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |