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NCT Number: NCT07608458

Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Location contact

Bradford Kim

CONTACT

[email protected]

626-218-1840

Bradford Kim

PRINCIPAL_INVESTIGATOR

About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

Actigraphy

Other

Wear activity tracker

Online Mindfulness Meditation

Behavioral

Complete mindfulness mediation

Other names: Online MBSR, Online Mindful Meditation, Online Mindfulness Relaxation, Online Mindfulness-Based Stress Reduction, Web-Based Mindfulness Meditation

Smartphone Application-based Intervention

Behavioral

Receive access to Headspace

Other names: Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based Intervention

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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