Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
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: Nitrous oxide.
- Кому может быть актуально
- Состояния в реестре: Procedural Pain, Pain Catastrophizing, Procedural Anxiety. Базовые параметры: 21 лет — 85 лет · Мужчины.
- 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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Обзор
This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful tool for improving experience of care during vasectomy.
Подробное описание
Patients scheduled for vasectomy at Beth Israel Deaconess Medical Center will be contacted and offered enrollment in the study. Vasectomy will occur according to standard-of-care and all participants will receive the typical lidocaine injections at the beginning of the procedure. Before the start of the vasectomy, a study staff member will help participants put on a plastic gas mask and demonstrate how to turn the gas up or down using the remote control. Nitrous oxide and oxygen will be given through a plastic mask. A remote control given to participants will allow them to adjust the nitrous oxide based on their comfort. The Nitrouseal® machine used in this study limits nitrous oxide to concentrations to "minimal sedation" (0-50%), which are levels where a person remains awake and is able to talk and breath normally.
Before the day of a participant's vasectomy, they will be asked questions related to demographics and medical history to determine study eligibility. Immediately before and after vasectomy, participants will be asked to describe their anxiety and pain levels. At two-weeks and three-months after vasectomy, a brief electronic survey will be sent to participants' email asking about recollection of pain and anxiety and satisfaction with the procedure.
Вмешательства
- Препарат Nitrous oxide
Nitrous oxide administered at concentrations of minimal sedation (0-50%). Participants will be able to adjust the level of gas throughout the vasectomy using a handheld remote control.
Первичные конечные точки
- Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P) [Срок оценки: Measured immediately after completion of vasectomy]
Вторичные конечные точки (8)
- Anticipated pain assessed by the Visual Analog Scale for Pain (VAS-P) [Срок оценки: Measured immediately prior to vasectomy]
- Anticipated anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A) [Срок оценки: Measured immediately prior to vasectomy]
- Procedural anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A) [Срок оценки: Measured immediately after completion of vasectomy]
- Recalled pain assessed by the Visual Analog Scale for Pain (VAS-P) [Срок оценки: Measured two weeks and three months after vasectomy]
- Recalled anxiety assessed by the Visual Analog Scale for Pain (VAS-P) [Срок оценки: Measured two weeks and three months after vasectomy]
- Satisfaction assessed by Likert scale [Срок оценки: Measured during and two weeks after vasectomy]
- Operator ease of performing vasectomy [Срок оценки: Measured immediately after urologist finishes vasectomy]
- Emergent adverse events as assessed by frequency of incidents [Срок оценки: Measured during and up to 30 days after day of vasectomy]
Критерии участия
Критерии включения
- Scheduled for vasectomy
- Aged 21 to 85 years
- Suitable for receipt of inhaled nitrous oxide/oxygen
- Access to an email and computer
Критерии исключения
- Perioral facial hair impeding good mask seal
- Cognitive impairment that impedes ability to complete survey questions
- Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy
- Has any of the following medical conditions, which contraindicate use of nitrous oxide:
- Inner ear, bariatric or eye surgery within the last 2 weeks,
- Current emphysematous blebs,
- Severe B-12 deficiency,
- Bleomycin chemotherapy within the past year,
- Heart attack within the past year,
- Stroke within the past year,
- Class III or higher heart failure.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Beth Israel Deaconess Medical Center — Boston
Идентификаторы
NCT: NCT05895383 · 2023P-000328