Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy

Официальное название

Scheduled Meditation for Perioperative Optimization: A Randomized Controlled Trial on Postoperative Outcomes, Pain, Anxiety, Insomnia, Stress, and Mobility in Pancreatectomy Patients

Обзор

This clinical trial tests the feasibility and how well a scheduled meditation intervention works to improve postoperative outcomes such as pain, anxiety, insomnia, stress and mobility for patients undergoing pancreatectomy. Many patients undergoing pancreatectomy surgery report clinically important fatigue, pain, and/or reduction in quality of life. Meditation is a behavioral intervention that has been studied in a variety of medical and surgical settings, where it has been associated with reductions in pain, anxiety, blood pressure, and lack of sleep, and in some cases with decreased pain and shorter length of stay. The meditation intervention using Headspace is an easily accessible and interactive way to complete scheduled meditation. This may improve postoperative outcomes for patients undergoing pancreatectomy.

Подробное описание

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of implementing a meditation-based intervention in patients undergoing pancreatectomy, as measured by recruitment, retention, and participant compliance with the prescribed modules II. Evaluate the effect of a perioperative meditation intervention on anxiety, as measured by changes in State-Trait Anxiety Inventory (STAI) scores from baseline to one month postoperatively.

SECONDARY OBJECTIVE:

I. To observe the relationship of meditation intervention on change in health-related quality of life (HRQOL) outcomes for pain and sleep quality from baseline through one month postoperatively.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive access to the Headspace application. Patients complete mindfulness meditation including focused breathing, awareness of thought patterns, and management of mind-wandering for 10 minutes once daily (QD) for 3 weeks prior to surgery and twice daily (BID) for 1 month after surgery. Patients wear a Garmin activity tracker throughout the study.

ARM II: Patients receive access to the Headspace application at the time of hospital discharge and will be informed of the availability of the "Basics" meditation pack. Patients wear a Garmin activity tracker throughout the study.

Вмешательства

• Другое Actigraphy
  Wear activity tracker
• Поведенческое Online Mindfulness Meditation
  Complete mindfulness mediation
• Поведенческое Smartphone Application-based Intervention
  Receive access to Headspace
• Другое Survey Administration
  Ancillary studies

Первичные конечные точки

• Proportion of enrolled patients who complete the final study assessment (retention) [Срок оценки: Up to 6 months]
• Proportion of prescribed meditation modules completed (compliance) [Срок оценки: Up to 6 months]
• Change in patient-reported anxiety symptoms [Срок оценки: From baseline up to day 28]
• Proportion of invited patients who agree to participate (recruitment) [Срок оценки: Up to 6 months]

Вторичные конечные точки (4)

• Change in patient-reported pain - Numeric Rating Scale [Срок оценки: rom the baseline assessment conducted three weeks prior to surgery through one month after surgery.]
• Change in patient-reported pain - Brief Pain Inventory [Срок оценки: From the baseline assessment conducted three weeks prior to surgery up to one month after surgery.]
• Change in patient-reported Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: From baseline up to one month after surgery.]
• Change in patient-reported Insomnia Severity Index (ISI) [Срок оценки: From baseline up to one month after surgery.]

Критерии участия

Критерии включения

• Documented informed consent of the participant and/or legally authorized representative
• Willing to install required apps on personal smartphone
• Willing to wear a Garmin wearable device throughout the study
• Age: ≥ 18 years
• Ability to read and understand English for questionnaires
• Owns a smartphone
• Comfortable with routine smartphone use
• Scheduled to undergo pancreatectomy

Критерии исключения

• Participants with prior formal training in meditation or mindfulness (e.g., completion of structured courses, workshops, or certification programs)
• Participants who currently engage in a structured meditation or mindfulness practice, including regular use of mobile applications (e.g., Headspace, Calm, or similar platforms) or other formalized routines

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

• City of Hope Medical Center — Duarte

Идентификаторы

NCT: NCT07608458 · 25479 · NCI-2026-03206 · 25479 · P30CA033572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗