Topics in spinal cord injury rehabilitation · 2022
Going Remote: A Revised Study Protocol for a Pilot Randomized Controlled Trial for Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Philippus Angela, Nupp Jason, MacIntyre Bria, Welch Abigail, Ali Asma, vanderValk Jennifer, Monden Kimberley R
Аннотация
BACKGROUND: The incidence of anxiety in adults with spinal cord injury/disorder (SCI/D) exceeds that of the general population. Heart rate variability (HRV) biofeedback training is a potential treatment associated with a reduction in stress and anxiety, however HRV training has not been explored in the SCI/D population.
OBJECTIVES: To describe a modified protocol piloting HRV training to reduce anxiety associated with SCI/D and detail the COVID-19-related modifications.
METHODS: To test the feasibility of the biofeedback treatment, 30 adults with SCI/D will complete this pilot randomized controlled trial. Enrollment started in January 2020, halted in March 2020 due to the COVID-19 pandemic, and resumed in March 2021 with a modified protocol. Protocol modifications are documented using the Framework for Reporting Adaptations and Modifications (FRAME). Participants are allocated to the treatment or control arm and undergo eight sessions of physiological monitoring at home using a commercially available HRV sensor and mobile application, which also delivers biofeedback training for those in the treatment arm. Surveys are administered following each session to capture self-reported stress, anxiety, and mood. The study is approved by the HCA-HealthONE institutional review board and is registered with clinicaltrials.gov (NCT# 03975075).
CONCLUSION: COVID-19 has changed the research landscape, forcing scientists to rethink their study designs to address patient and staff safety in this new context. Our modified protocol accomplished this by moving the treatment setting and delivery out of the clinic and into the home. In doing so, we address patient and staff safety, increase external validity, and reduce participant burden.
OBJECTIVES: To describe a modified protocol piloting HRV training to reduce anxiety associated with SCI/D and detail the COVID-19-related modifications.
METHODS: To test the feasibility of the biofeedback treatment, 30 adults with SCI/D will complete this pilot randomized controlled trial. Enrollment started in January 2020, halted in March 2020 due to the COVID-19 pandemic, and resumed in March 2021 with a modified protocol. Protocol modifications are documented using the Framework for Reporting Adaptations and Modifications (FRAME). Participants are allocated to the treatment or control arm and undergo eight sessions of physiological monitoring at home using a commercially available HRV sensor and mobile application, which also delivers biofeedback training for those in the treatment arm. Surveys are administered following each session to capture self-reported stress, anxiety, and mood. The study is approved by the HCA-HealthONE institutional review board and is registered with clinicaltrials.gov (NCT# 03975075).
CONCLUSION: COVID-19 has changed the research landscape, forcing scientists to rethink their study designs to address patient and staff safety in this new context. Our modified protocol accomplished this by moving the treatment setting and delivery out of the clinic and into the home. In doing so, we address patient and staff safety, increase external validity, and reduce participant burden.