Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy
Hepatocellular Carcinoma · Pancreas Cancer · Biliary Tract Neoplasms
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 70 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Arm I (Headspace meditation)
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.
Other: Actigraphy · Behavioral: Online Mindfulness Meditation · Behavioral: Smartphone Application-based Intervention · Other: Survey Administration
Arm II (Delayed access to Headspace)
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 · Behavioral: Online Mindfulness Meditation · Behavioral: Smartphone Application-based Intervention · Other: Survey Administration
Actigraphy OTHER
Wear activity tracker
Online Mindfulness Meditation BEHAVIORAL
Complete mindfulness mediation
Smartphone Application-based Intervention BEHAVIORAL
Receive access to Headspace
Survey Administration OTHER
Ancillary studies
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Proportion of enrolled patients who complete the final study assessment (retention)
Time frame: 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)
Time frame: 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 symptoms
Time frame: From 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)
Time frame: 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.
Secondary measures
Change in patient-reported pain - Numeric Rating Scale
Time frame: rom the baseline assessment conducted three weeks prior to surgery through one month after surgery.
Change in patient-reported pain from baseline three weeks prior to surgery through one month postoperatively, measured using the Numeric Rating Scale (NRS, 0 -10 ). 0 means no pain to 10 means worst pain possible.
Change in patient-reported pain - Brief Pain Inventory
Time frame: From the baseline assessment conducted three weeks prior to surgery up to one month after surgery.
Change in patient-reported pain from baseline three weeks prior to surgery through one month postoperatively, measured using the Brief Pain Inventory.(BPI). 0 means no pain to 10 means worst pain possible.
Change in patient-reported Pittsburgh Sleep Quality Index (PSQI)
Time frame: From baseline up to one month after surgery.
Self-reported questionnaire will be used to measure sleep quality and sleep patterns over the past month. PSQI will be interpreted by totaling the component scores into a global score ranging from 0 to 21, where higher scores indicate poorer sleep quality; a score greater than 5 generally suggests significant sleep disturbance or poor sleep quality.
Change in patient-reported Insomnia Severity Index (ISI)
Time frame: From baseline up to one month after surgery.
Self-reported questionnaire will be used to assess the severity and impact of insomnia symptoms, including difficulty falling asleep, staying asleep, and the effect of sleep problems on daily functioning. The ISI is interpreted using a total score from 0 to 28: 0-7 indicates no clinically significant insomnia, 8-14 indicates subthreshold insomnia, 15-21 indicates moderate insomnia, and 22-28 indicates severe insomnia.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
City of Hope Medical CenterDuarte, California, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- City of Hope Medical Center
- Study start
- Jan 1, 2027 Estimated
- Primary completion
- Nov 25, 2027 Estimated
- Study completion
- Nov 25, 2027 Estimated
- First posted
- May 27, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Scheduled Meditation for Perioperative Optimization: A Randomized Controlled Trial on Postoperative Outcomes, Pain, Anxiety, Insomnia, Stress, and Mobility in Pancreatectomy Patients
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026