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Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy

19. maj 2026 opdateret af: City of Hope Medical Center

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Duarte, California, Forenede Stater, 91010
        • City of Hope Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Bradford Kim

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Undersøgelsesadministration
Hjælpestudier
Andet: Actigraphy
Wear activity tracker
Adfærdsmæssigt: Online Mindfulness Meditation
Complete mindfulness mediation
Andre navne:
  • Online MBSR
  • Online Mindful Meditation
  • Web-baseret mindfulness meditation
  • Online Mindfulness afslapning
  • Online Mindfulness-baseret stressreduktion
Adfærdsmæssigt: Smartphone Application-based Intervention
Receive access to Headspace
Andre navne:
  • Smartphone App-based Intervention
  • Smartphone Intervention
  • Smartphone-based Intervention
Eksperimentel: 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.
Andet: Undersøgelsesadministration
Hjælpestudier
Andet: Actigraphy
Wear activity tracker
Adfærdsmæssigt: Online Mindfulness Meditation
Complete mindfulness mediation
Andre navne:
  • Online MBSR
  • Online Mindful Meditation
  • Web-baseret mindfulness meditation
  • Online Mindfulness afslapning
  • Online Mindfulness-baseret stressreduktion
Adfærdsmæssigt: Smartphone Application-based Intervention
Receive access to Headspace
Andre navne:
  • Smartphone App-based Intervention
  • Smartphone Intervention
  • Smartphone-based Intervention

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in patient-reported pain - Numeric Rating Scale
Tidsramme: 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.
rom the baseline assessment conducted three weeks prior to surgery through one month after surgery.
Change in patient-reported pain - Brief Pain Inventory
Tidsramme: 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.
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)
Tidsramme: 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.
From baseline up to one month after surgery.
Change in patient-reported Insomnia Severity Index (ISI)
Tidsramme: 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.
From baseline up to one month after surgery.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

City of Hope Medical Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Bradford Kim, City of Hope Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. juni 2026

Primær færdiggørelse (Anslået)

25. november 2026

Studieafslutning (Anslået)

25. november 2026

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25479 (Anden identifikator: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH-bevilling/kontrakt)
  • NCI-2026-03206 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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