Using Mindfulness in an Enhanced Recovery After Surgery Protocol to Support Recovery After Colorectal Surgery

Официальное название

Using Mindfulness in an Enhanced Recovery After Surgery Protocol to Support Recovery After Colorectal Surgery: A Single Center RCT Feasibility Study

Обзор

This study teaches participants who are having colorectal surgery how to use mindfulness to feel calmer and manage pain better. Participants will be randomized (like a flip of a coin) into one of two groups: Mindfulness Intervention or Standard Treatment. Those in the Mindfulness group will have a 30-minute Zoom session before surgery to learn simple mindfulness exercises like deep breathing, using senses, and staying focused on the present. On the day after surgery, participants will watch a short video review of the mindfulness exercises. Regardless of the group assigned, participants may be asked to complete questionnaires, and some participants will be asked to complete a semi-structured interview via Zoom, about 2 weeks to 1 month after surgery. Additionally, access to the mindfulness curriculum will be provided to those not randomized to that group. Investigators will collect information such as age, surgery details, pain levels, and pain medication usage. Participants will also fill out surveys before and after surgery to assess physical and mental well-being. All personal information will be kept safe, and interviews or Zoom sessions will be deleted after notes are taken without names attached. Participants will be in this study for about 4 weeks.

Вмешательства

• Поведенческое Mindfulness Intervention
  Those in the Mindfulness Intervention group will have a 30-minute Zoom session before surgery to learn simple mindfulness exercises like deep breathing, using senses, and staying focused on the present. After surgery, these participants will receive a refresher on the mindfulness curriculum.

Первичные конечные точки

• Percentage of participants who completed all mindfulness interventions as measured by study logs [Срок оценки: Up to one year]

Вторичные конечные точки (1)

• Percentage of participants who complete all study questionnaires/text message reminders as measured by study logs [Срок оценки: Up to one year]

Критерии участия

Критерии включения

• Patients scheduled for a bowel resection and enrolled in the UH Institutional ERAS pathway
• Patients will be admitted to the inpatient hospital for at least one day postoperatively
• Aged 18 or older
• Receiving surgery at designated University Hospitals locations (Cleveland Medical Center, Ahuja, St. John's Medical Center)
• English-speaking
• Access to the internet via phone, laptop, or iPad

Критерии исключения

• Surgery for palliative purposes only
• Surgery for ostomy take-down only
• Discharged on day of surgery
• History of substance use disorder
• Allergy or intolerance to all opioids
• Insufficient English proficiency
• No access to the internet outside clinical settings
• Significant visual, hearing or cognitive impairment

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

Поддерживающая терапия

Центры проведения

США · 1 центр

• University Hospitals Cleveland Medical Center — Cleveland

Идентификаторы

NCT: NCT07026786 · STUDY20250408

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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