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NCT07608458

Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy

StatusNot Yet Recruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved 12 months later.

See at-risk trials from City of Hope Medical Center

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Nov 25, 2026 to Nov 25, 2027
    • Start date: Oct 1, 2026 to Jan 1, 2027
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 4 of 4 entries
  2. Start date: Jun 25, 2026 to Oct 1, 2026v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

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

Secondary (4)

Change in patient-reported pain - Numeric Rating Scale
Change in patient-reported pain - Brief Pain Inventory
Change in patient-reported Pittsburgh Sleep Quality Index (PSQI)
Change in patient-reported Insomnia Severity Index (ISI)

Arms and interventions

Arm I (Headspace meditation)Experimental

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 QD for 3 weeks prior to surgery and BID for 1 month after surgery. Patients wear a Garmin activity tracker throughout the study.

Arm II (Delayed access to Headspace)Experimental

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.

Other: Actigraphy, Survey Administration

Behavioral: Online Mindfulness Meditation, Smartphone Application-based Intervention

Sites

1 site in 1 country

  • City of Hope Medical CenterDuarte, California, United States