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Идёт набор NCT07218289

Green Light for Post-Operative Wellness

Без фазы С лечением Surgery

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: Bright Green Light Therapy, Dim White Light Therapy.
Кому может быть актуально
Состояния в реестре: Surgery. Базовые параметры: от 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

Green Light Therapy to Reduce Pain and Promote Wellness After Surgery: A Randomized Controlled Trial in Adult Post-Operative Patients

Обзор

This is an unblinded, parallel group randomized controlled trial to evaluate bright green light as an adjunct therapy after surgery at UPMC Shadyside. The primary outcome measure will be pain intensity with secondary outcome measures including opioid requirements, sleep quality, mood, and overall post-operative recovery. Specific aims/hypotheses for this study are as follows: Aim 1: To assess bright green light therapy's potential as a complementary post-operative analgesic strategy in patients recovering from surgery Hypothesis 1: Participants exposed to bright green light, in comparison to dim white (ambient) light, will have improved postoperative pain scores and lower opioid use. Aim 2: To examine the impact of bright green light therapy on patient-centered measures of post-operative recovery that may be related to improved circadian function. Hypothesis 2: Participants exposed to bright green light, in comparison to dim white (ambient) light, will have improved quality of post-operative recovery, enhanced sleep, and reduced anxiety and depression.

Подробное описание

This research study is being done to evaluate the use of light therapy following surgery at UPMC Shadyside Hospital (Pittsburgh, PA). Light therapy after surgery may reduce pain and pain medication requirements, and it may improve sleep, mood, and overall post-surgery recovery. The proposed study design of a randomized controlled trial investigates the use of bright green light therapy for post-operative pain management and wellness.

Вмешательства

  • Устройство Bright Green Light Therapy
    Day Light Classic Plus light therapy lamp with filter to yield bright green light.
  • Устройство Dim White Light Therapy
    Day Light Classic Plus light therapy lamp with filter to yield dim white light.

Первичные конечные точки

  • Incisional Pain Intensity with Movement [Срок оценки: Post-Operative Day 2]
Вторичные конечные точки (7)
  • Incisional Pain Intensity at Rest [Срок оценки: Post-Operative Day 2]
  • Oral Morphine Equivalents (OME) [Срок оценки: Post-Operative Day 1, and Post-Operative Day 2]
  • Sleep Disturbance [Срок оценки: Post-Operative Day 7]
  • Depression [Срок оценки: Post-Operative Day 7]
  • Anxiety [Срок оценки: Post-Operative Day 7]
  • Overall quality of Post-Operative Recovery [Срок оценки: on Post-Operative Day 2, and Post-Operative Day 7]
  • Hospital Length of Stay [Срок оценки: Up to 30 Days Post-Operatively]

Критерии участия

Критерии включения

  • Age >/= 18 years
  • Planned to undergo laparoscopic or robotic surgery at UPMC Shadyside Hospital
  • Anticipated post-operative length of stay >/= 48 hours
  • Able to speak and read English fluently, with the capacity to provide informed consent and complete the associated surveys independently

Критерии исключения

  • Pregnancy
  • History of significant ocular issues/dysfunction (†‡ ) (e.g., glaucoma, ocular trauma, macular degeneration, cataracts) that would interfere with the ocular mechanism of action
  • History of significant neurological disease (‡) (e.g., traumatic brain injury, stroke, neurodegenerative disease) that would compromise the reliability of pain screening and/or interfere with the central mechanism of action
  • History of bipolar disorder or schizophrenia, which could increase the risk of an adverse reaction to light exposure (i.e., acute mania)
  • History of splenectomy, which would interfere with the mechanism of action
  • Ocular issues corrected with contact lenses or spectacle corrective eyeglasses will NOT be considered a criterion for exclusion ‡Unclear cases will be at the discretion of the PI

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
  • UPMC Shadyside Hospital — Pittsburgh

Идентификаторы

NCT: NCT07218289 · STUDY25080068

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗