The Impact of Music Meditation Therapy on Pain, Mood, and Stress When Botulium Toxin (Botox) Injection is Utilized: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Pain Visual Analogue Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Music (Other)
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.
结局指标
主要结局
Pain Visual Analogue Scale (VAS)
时间窗: 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.'
次要结局
- Stress Visual Analogue Scale (VAS)(3 minutes)
- Mood Visual Analogue Scale (VAS)(3 minutes)
研究者
Richard Jermyn
Director, NeuroMusculoskeletal Institute
Rowan University