Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy
This study is exploring if a scheduled meditation program can help patients who are having a pancreatectomy (surgery to remove part or all of the pancreas) feel better after their operation. Many patients experience pain, anxiety, and fatigue after this surgery. This study uses the Headspace app for mindfulness meditation and asks participants to wear an activity tracker. We want to see if this approach is practical and if it can reduce anxiety. We're also looking at how it might affect pain and sleep quality. You might be able to join if you are 18 or older, have a smartphone you're comfortable using, and are scheduled for a pancreatectomy. The study aims to enroll 70 participants.
- Study design
- This interventional study plans to enroll 70 participants and will compare two groups: one receiving early access to Headspace meditation and another receiving it later.
- What's involved
- You would install required apps on your smartphone, wear a Garmin activity tracker throughout the study, and complete mindfulness meditation sessions daily for several weeks before and after surgery. You will also complete surveys.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for up to 6 months to assess retention and compliance, and anxiety symptoms are measured up to day 28.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy
At a glance
Conditions
NCT07608458
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
City of Hope Medical Center
Duarte, Californiastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Bradford Kim · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- Proportion of enrolled patients who complete the final study assessment (retention)Up to 6 months
Retention will be considered feasible if ≥ 70% of enrolled participants are retained. Will be estimated along with the 95% exact binomial confidence interval.
- Proportion of prescribed meditation modules completed (compliance)Up to 6 months
Each participant's proportion of completed meditation modules will be calculated using usage data from the Headspace mobile application. Participants will then be classified as high (\> 60%), medium (20-60%), or low (\< 20%) compliance. Will be estimated along with the 95% exact binomial confidence interval.
- Change in patient-reported anxiety symptomsFrom baseline up to day 28
Measured using the State-Trait Anxiety Inventory (STAI). Response is defined as a reduction of at least 6 points on STAI at date of surgery date relative to baseline. The proportion of participants meeting this threshold will be reported. Will be estimated along with the 95% exact binomial confidence interval. Within-group mean change in STAI will be examined using paired t-tests (comparing any two time points of interest).
- Proportion of invited patients who agree to participate (recruitment)Up to 6 months
Recruitment will be considered feasible if ≥ 50% of eligible patients enroll. Will be estimated along with the 95% exact binomial confidence interval.