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Идёт набор NCT05949177

Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction

Без фазы С лечением Anterior Cruciate Ligament Injuries

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: Graded Exposure and Mindfulness Meditation, Waitlist Control.
Кому может быть актуально
Состояния в реестре: Anterior Cruciate Ligament Injuries. Базовые параметры: 14 лет — 35 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

The GEMM Trial: Graded Exposure and Mindfulness Meditation for Patients Post- ACL Reconstruction

Обзор

To evaluate the effect of graded exposure and mindfulness meditation after ACLR, the investigators will determine the effect of graded exposure and mindfulness meditation to 1) decrease self-reported injury-related fear and reinjury anxiety, and 2) improve lower extremity reaction time when compared to a waitlist control group.

Подробное описание

Injury-related fear after anterior cruciate ligament reconstruction (ACLR) is associated with secondary ACL injury and slower reaction time. Graded exposure (GE) and mindfulness meditation (MM) have reduced injury-related fear, but has not been explored together in patients post-ACLR. GE and MM delivered via the Headspace application is feasible for individuals post-ACLR. GEMM allows athletic trainers' to easily implement MM into their practice. The aim of this randomized single-blinded clinical trial is to determine the efficacy of 5-weeks of GEMM to decrease injury-related fear and reinjury anxiety and improve reaction time in participants 6 months to 10-years post-ACLR. Participants will be randomized into a GEMM group or waitlist control group. Participants will complete the Photographic Series of Sports Activities for ACLR, Reinjury Anxiety Inventory, the Tampa Scale of Kinesiophobia-11 and a lower extremity reaction time task pre and post the 5-week period. The investigators hypothesize that participants in the GEMM group will exhibit decreased injury-related fear and reinjury anxiety and faster reaction time when compared to the waitlist controls.

Вмешательства

  • Поведенческое Graded Exposure and Mindfulness Meditation
    Participants will complete graded exposure and will be encouraged to face fear-eliciting situations. Participants will also complete mindfulness meditation guided through the Headspace mobile application. Participants will complete the graded exposure one time per week and will complete the mindfulness meditation 4 times per week.
  • Поведенческое Waitlist Control
    Participants will receive an email stating that they will receive access to 5-weeks of Headspace after 5-weeks. Participants will be also asked to not change their normal routines or download apps for relaxation, meditation, or sleep during 5-weeks. After completion of the outcome assessments at 5-weeks, participants in this group will receive access to 5-weeks of Headspace.

Первичные конечные точки

  • Change in Task Specific Fears [Срок оценки: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5]
  • Change in Overall Injury-Related Fear [Срок оценки: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5]
Вторичные конечные точки (2)
  • Change in Reinjury Anxiety [Срок оценки: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5]
  • Change in Lower Extremity Reaction Time [Срок оценки: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5]

Критерии участия

Критерии включения

  • Ages 14-35 years
  • Have self-reported levels of fear on the Tampa Scale of Kinesiophobia-11 and the Photographic Series of Sports Activities for ACLR
  • Injured their knee playing or training for sports (recreational or organized)
  • Have a history of unilateral ACLR
  • 6 months to 10-years post-ACLR

Критерии исключения

  • History of secondary ACL injury
  • Do not exhibit elevated injury-related fear
  • Concomitant surgeries at the time of ACL reconstruction

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Woollen Gymnasium, 300 South Road — Chapel Hill

Идентификаторы

NCT: NCT05949177 · 23-1412 · 2223GP01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗