Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy
2026년 5월 19일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
70
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope Medical Center
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연락하다:
- Bradford Kim
- 전화번호: 626-218-1840
- 이메일: brakim@coh.org
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수석 연구원:
- Bradford Kim
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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보조 연구
Wear activity tracker
Complete mindfulness mediation
다른 이름들:
Receive access to Headspace
다른 이름들:
|
|
실험적: 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.
|
보조 연구
Wear activity tracker
Complete mindfulness mediation
다른 이름들:
Receive access to Headspace
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of enrolled patients who complete the final study assessment (retention)
기간: Up to 6 months
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Retention will be considered feasible if ≥ 70% of enrolled participants are retained.
Will be estimated along with the 95% exact binomial confidence interval.
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Up to 6 months
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Proportion of prescribed meditation modules completed (compliance)
기간: Up to 6 months
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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.
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Up to 6 months
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Change in patient-reported anxiety symptoms
기간: From baseline up to day 28
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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).
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From baseline up to day 28
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Proportion of invited patients who agree to participate (recruitment)
기간: Up to 6 months
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Recruitment will be considered feasible if ≥ 50% of eligible patients enroll.
Will be estimated along with the 95% exact binomial confidence interval.
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Up to 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in patient-reported pain - Numeric Rating Scale
기간: rom the baseline assessment conducted three weeks prior to surgery through one month after surgery.
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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.
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rom the baseline assessment conducted three weeks prior to surgery through one month after surgery.
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Change in patient-reported pain - Brief Pain Inventory
기간: From the baseline assessment conducted three weeks prior to surgery up to one month after surgery.
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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.
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From the baseline assessment conducted three weeks prior to surgery up to one month after surgery.
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Change in patient-reported Pittsburgh Sleep Quality Index (PSQI)
기간: From baseline up to one month after surgery.
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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.
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From baseline up to one month after surgery.
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Change in patient-reported Insomnia Severity Index (ISI)
기간: From baseline up to one month after surgery.
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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.
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From baseline up to one month after surgery.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Bradford Kim, City of Hope Medical Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 25일
기본 완료 (추정된)
2026년 11월 25일
연구 완료 (추정된)
2026년 11월 25일
연구 등록 날짜
최초 제출
2026년 5월 13일
QC 기준을 충족하는 최초 제출
2026년 5월 19일
처음 게시됨 (실제)
2026년 5월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 19일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25479 (기타 식별자: City of Hope Medical Center)
- P30CA033572 (미국 NIH 보조금/계약)
- NCI-2026-03206 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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