- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02690194
A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures.
A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Undergoing medical procedures is reported to cause stress and anxiety among many individuals.This can trigger the sympathetic nervous response, including decreased skin temperature, increased pulse, and increased blood pressure. While evolutionary advantageous, this response has deleterious effects on the healing process. Heightened stress levels can also trigger an increased release of cortisol, a naturally produced steroid hormone known to hinder the immune response. In response to high levels of stress, a patient's tolerance for pain decreases and the perceived pain level increases.
Relaxation techniques can assist in reducing the stress and anxiety levels of a patient, which allows for lower perceived pain and more rapid healing. Many relaxation techniques exist, including acupuncture, child life intervention, breathing therapy and guided imagery. Buddhify, a mobile application, incorporates breathing therapy and audio-guided imagery into brief relaxation sessions, with the goal of reducing the stress and anxiety levels of the user. This application presents a convenient option for patients to use prior to undergoing a procedure. If proven to be effective, this application could be more widely used to help reduce the stress level, anxiety level and subsequent perceived pain level of patients, ultimately improving their healing reaction.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02115
- Boston Childrens Hospital - Sports Medicine
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Patients aged 14 and older undergoing an invasive procedure by Dr. Gianmichel Corrado at the Division of Sports Medicine of Boston Children's Hospital.
Exclusion Criteria:
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Плацебо Компаратор: Placebo Group
|
The placebo group will wear headphones and listen to nature sounds.
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Экспериментальный: Experimental (Buddhify) Group
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The experimental group will complete a Buddhify relaxation therapy session, before their injection.
This therapy consists of wearing headphones and listening to guided meditation instructions.
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Без вмешательства: Control Group
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure
Временное ограничение: Pre-therapy/pre-procedure
|
Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg
|
Pre-therapy/pre-procedure
|
Pre-therapy/Pre-procedure Stress Level Measured by Pulse
Временное ограничение: Pre-therapy/pre-procedure
|
Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.
|
Pre-therapy/pre-procedure
|
Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate
Временное ограничение: Pre-therapy/pre-procedure
|
Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.
|
Pre-therapy/pre-procedure
|
Pre-therapy/Pre-procedure Anxiety Level
Временное ограничение: Pre-therapy/pre-procedure
|
Pre-therapy/pre-procedure anxiety level measure by the State-Trait Anxiety Inventory.
The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.
|
Pre-therapy/pre-procedure
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse
Временное ограничение: Post-therapy/pre-procedure
|
Post-therapy/pre-procedure change in stress level measured by pulse in beats per minute.
Value at prost-therapy/pre-procedure minus value at pre-therapy/pre-procedure.
|
Post-therapy/pre-procedure
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Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate
Временное ограничение: Post-therapy/pre-procedure
|
Post-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.
Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.
|
Post-therapy/pre-procedure
|
Post-therapy/Pre-procedure Change in Anxiety Level
Временное ограничение: Post-therapy/pre-procedure
|
Post-therapy/Pre-procedure change in anxiety level measure by the State-Trait Anxiety Inventory.
Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.
|
Post-therapy/pre-procedure
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Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure
Временное ограничение: Post-therapy/Pre-procedure
|
Post-therapy/pre-procedure change in stress level measured by blood pressure measured in mmHg.
Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.
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Post-therapy/Pre-procedure
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Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale
Временное ограничение: Immediately post-procedure
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Perceived pain level of the procedure as assessed by the Wong-Baker FACES pain rating scale 1-10.
A score of 1 indicates "no hurt" (a better outcome) while a score of 10 indicates "hurts worst" (worst outcome).
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Immediately post-procedure
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Drink in Last Hour
Временное ограничение: Pre-therapy/Pre-procedure
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Indication of if the patient has had a drink in the last hour
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Pre-therapy/Pre-procedure
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Eat in Last Hour
Временное ограничение: Pre-therapy/Pre-procedure
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Indication of if the patient has eaten in the last hour
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Pre-therapy/Pre-procedure
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Exercise in Last Hour
Временное ограничение: Pre-therapy/Pre-procedure
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Indication of if the patient has exercised in the last hour
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Pre-therapy/Pre-procedure
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Injection Experiences
Временное ограничение: Pre-therapy/Pre-procedure
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Indication of prior injection experiences
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Pre-therapy/Pre-procedure
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Number of Injections
Временное ограничение: Pre-therapy/Pre-procedure
|
Average number of injections for patients that indicated that they previously have had injections
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Pre-therapy/Pre-procedure
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Gianmichel Corrado, MD, Boston Children's Hospital
Публикации и полезные ссылки
Общие публикации
- Heilbrunn BR, Wittern RE, Lee JB, Pham PK, Hamilton AH, Nager AL. Reducing anxiety in the pediatric emergency department: a comparative trial. J Emerg Med. 2014 Dec;47(6):623-31. doi: 10.1016/j.jemermed.2014.06.052. Epub 2014 Sep 27.
- Kiecolt-Glaser JK, Marucha PT, Malarkey WB, Mercado AM, Glaser R. Slowing of wound healing by psychological stress. Lancet. 1995 Nov 4;346(8984):1194-6. doi: 10.1016/s0140-6736(95)92899-5.
- Lim YC, Yobas P, Chen HC. Efficacy of relaxation intervention on pain, self-efficacy, and stress-related variables in patients following total knee replacement surgery. Pain Manag Nurs. 2014 Dec;15(4):888-96. doi: 10.1016/j.pmn.2014.02.001. Epub 2014 Jun 21.
- Bae H, Bae H, Min BI, Cho S. Efficacy of acupuncture in reducing preoperative anxiety: a meta-analysis. Evid Based Complement Alternat Med. 2014;2014:850367. doi: 10.1155/2014/850367. Epub 2014 Sep 2.
- Ko YL, Lin PC. The effect of using a relaxation tape on pulse, respiration, blood pressure and anxiety levels of surgical patients. J Clin Nurs. 2012 Mar;21(5-6):689-97. doi: 10.1111/j.1365-2702.2011.03818.x. Epub 2011 Nov 17.
- Ebrecht M, Hextall J, Kirtley LG, Taylor A, Dyson M, Weinman J. Perceived stress and cortisol levels predict speed of wound healing in healthy male adults. Psychoneuroendocrinology. 2004 Jul;29(6):798-809. doi: 10.1016/S0306-4530(03)00144-6.
- Worley CA. 'Why won't this wound heal?' Factors affecting wound repair. Dermatol Nurs. 2004 Aug;16(4):360-1. No abstract available.
- Sugimoto D, Slick NR, Mendel DL, Stein CJ, Pluhar E, Fraser JL, Meehan WP 3rd, Corrado GD. Meditation Monologue can Reduce Clinical Injection-Related Anxiety: Randomized Controlled Trial. J Evid Based Integr Med. 2021 Jan-Dec;26:2515690X211006031. doi: 10.1177/2515690X211006031.
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- IRB-P00016464
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Placebo Group
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Riphah International UniversityЗавершенныйХроническая боль в поясницеПакистан
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Seyda Ersahan, DDS, PhDАктивный, не рекрутирующийВерхушечный периодонтит | Периапикальное поражениеТурция
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Unity Health TorontoНеизвестныйГестационный сахарный диабет
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University of FloridaЗавершенныйАпноэ сна, обструктивное | ХрапСоединенные Штаты
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Centre Hospitalier Universitaire de Saint EtienneЗавершенный
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Riphah International UniversityРекрутинг
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Izmir Bakircay UniversityЗавершенный
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University of TennesseeNational Cancer Institute (NCI); Regional One HealthРекрутингПотеря веса | Избыточный вес и ожирение | Поведение, ЗдоровьеСоединенные Штаты
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Universidade Estadual de LondrinaЗавершенныйПрием на работуБразилия
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Vanderbilt UniversityVanderbilt University Medical CenterЕще не набираютИзменения массы тела | Ожирение, Детство | Диетическое, ЗдоровоеСоединенные Штаты