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Идёт набор NCT07219095

Dance Mental Health App

Без фазы С лечением Ankle Injury Foot Injury Lower Extremity Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mental Health App.
Кому может быть актуально
Состояния в реестре: Ankle Injury, Foot Injury, Lower Extremity Injury. Базовые параметры: 13 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Use of a Mental Health App in the Recovery of Adolescent Dancers From a Lower Extremity Injury: A Randomized Controlled Trial

Обзор

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.

Вмешательства

  • Устройство Mental Health App
    Participants will use the SuperBetter mobile app to participate in gamified mental health activities 5 days per week, 10 minutes per day, for 12 weeks alongside their physical therapy.

Первичные конечные точки

  • Number (or percentage) of participants who have returned to full, unrestricted dance after injury [Срок оценки: 3, 6 and 12 months.]
Вторичные конечные точки (3)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Measures of Pediatric Anxiety, Depressive Symptoms, Pain Interference, and Mobility questionnaire [Срок оценки: enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months]
  • Self Compassion Scale (SCS) - Short Form questionnaire [Срок оценки: 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 [Срок оценки: enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Rady Children's Hospital — San Diego

Публикации

  • Christino MA, Fantry AJ, Vopat BG. Psychological Aspects of Recovery Following Anterior Cruciate Ligament Reconstruction. J Am Acad Orthop Surg. 2015 Aug;23(8):501-9. doi: 10.5435/JAAOS-D-14-00173. PMID 26209145
  • Gennarelli SM, Brown SM, Mulcahey MK. Psychosocial interventions help facilitate recovery following musculoskeletal sports injuries: a systematic review. Phys Sportsmed. 2020 Nov;48(4):370-377. doi: 10.1080/00913847.2020.1744486. Epub 2020 Mar 25. PMID 32186423
  • Walter HJ, Bukstein OG, Abright AR, Keable H, Ramtekkar U, Ripperger-Suhler J, Rockhill C. Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents With Anxiety Disorders. J Am Acad Child Adolesc Psychiatry. 2020 Oct;59(10):1107-1124. doi: 10.1016/j.jaac.2020.05.005. Epub 2020 May 18. PMID 32439401
  • Neff KD, Toth-Kiraly I, Yarnell LM, Arimitsu K, Castilho P, Ghorbani N, Guo HX, Hirsch JK, Hupfeld J, Hutz CS, Kotsou I, Lee WK, Montero-Marin J, Sirois FM, de Souza LK, Svendsen JL, Wilkinson RB, Mantzios M. Examining the factor structure of the Self-Compassion Scale in 20 diverse samples: Support for use of a total score and six subscale scores. Psychol Assess. 2019 Jan;31(1):27-45. doi: 10.1037 PMID 30124303
  • Worthen-Chaudhari L, McGonigal J, Logan K, Bockbrader MA, Yeates KO, Mysiw WJ. Reducing concussion symptoms among teenage youth: Evaluation of a mobile health app. Brain Inj. 2017;31(10):1279-1286. doi: 10.1080/02699052.2017.1332388. Epub 2017 Jun 30. PMID 28665690
  • Psihogios AM, Stiles-Shields C, Neary M. The Needle in the Haystack: Identifying Credible Mobile Health Apps for Pediatric Populations during a Pandemic and beyond. J Pediatr Psychol. 2020 Nov 1;45(10):1106-1113. doi: 10.1093/jpepsy/jsaa094. PMID 33068424
  • Semenchuk BN, Strachan SM, Fortier M. Self-Compassion and the Self-Regulation of Exercise: Reactions to Recalled Exercise Setbacks. J Sport Exerc Psychol. 2018 Feb 1;40(1):31-39. doi: 10.1123/jsep.2017-0242. Epub 2018 Mar 26. PMID 29580155
  • Neff KD, Bluth K, Toth-Kiraly I, Davidson O, Knox MC, Williamson Z, Costigan A. Development and Validation of the Self-Compassion Scale for Youth. J Pers Assess. 2021 Jan-Feb;103(1):92-105. doi: 10.1080/00223891.2020.1729774. Epub 2020 Mar 3. PMID 32125190

Идентификаторы

NCT: NCT07219095 · 812643

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗