Use of a Mental Health App in the Recovery of Adolescent Dancers From a Lower Extremity Injury: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number (or percentage) of participants who have returned to full, unrestricted dance after injury
研究概览
简要总结
This project aims to enhance self-compassion in adolescent dancers recovering from a foot and ankle injury by incorporating the use of a mental health intervention app using gamified design during their recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent (adult participant), or consent of parent/legal guardian in conjunction with adolescent assent (minor participant)
- •13 to 18 years of age
- •Endorses dance as their primary sport, or participates 3 days per week or greater in dance prior to injury
- •Stated willingness to comply with all study procedures including the intervention regimen and availability for the duration of the study
- •Access to a device with which the SuperBetter app can be downloaded and used
排除标准
- •Dance is not a primary sport or less than 3 days per week spent dancing prior to injury (skater, gymnast, other sport)
- •Requiring surgery or prior surgery for the injury being treated
- •Injury outside of the leg below the knee
- •Known eating disorder or bone density issue (documented abnormal Z score and/or eating disorder diagnosis upon review of the medical chart)
- •Verbalized plans to not return to dance after recovery from the injury
研究组 & 干预措施
SuperBetter Arm
Those randomized into the treatment group will be completing gamified mental health exercises in an app called SuperBetter for 10 minutes, 5 days per week, for 12 weeks alongside physical therapy.
干预措施: Mental Health App (Device)
Control Arm
Those randomized into the observation group need only attend their physical therapy appointments and complete the questionnaires but will not use the mental health app.
结局指标
主要结局
Number (or percentage) of participants who have returned to full, unrestricted dance after injury
时间窗: 3, 6 and 12 months.
Will be assessed as part of the clinical exam by asking current return to dance status
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) Measures of Pediatric Anxiety, Depressive Symptoms, Pain Interference, and Mobility questionnaire(enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Self Compassion Scale (SCS) - Short Form questionnaire(enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Foot and Ankle Ability Measure (FAAM) Activities of Daily Living subscale and Sports Subscale questionnaire(enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months)
研究者
Emily Cidambi
Orthopedic Surgeon
University of California, San Diego