이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation

2026년 9월 9일 업데이트: University of Minnesota

Quit With Sense: A Pilot Smoking Cessation Intervention Study Using Mindful Smoking and Smartphone-Based Sensor-Band

This pilot randomized controlled trial will test the feasibility of a smoking cessation intervention using mindful smoking practice and a smartphone-based sensor-band among adults who regularly smoke cigarettes.

Participants will be randomized to either an intervention group or a control group. Participants in the intervention group will receive a one-on-one mindful smoking guidance session, instructions for using a smartphone-based sensor-band, a mindfulness practice video, and smoking cessation information. Participants in the control group will receive smoking cessation information. The intervention period will last 8 weeks, with assessments at baseline, 8 weeks, and 4 months after completion of the intervention.

The study will evaluate feasibility, preliminary smoking cessation outcomes, and physiologic parameters including heart rate variation, skin temperature, resting heart rate, respiratory rate, and real-time heart rate during craving and mindful smoking practice.

연구 개요

상세 설명

Cigarette smoking is a leading preventable cause of morbidity and mortality and contributes to cancer, lung disease, health care costs, and reduced quality of life. Although many adults who smoke cigarettes attempt to quit, long-term cessation rates remain low. Mindfulness-based strategies may help people who smoke manage cravings by increasing awareness of present-moment thoughts, emotions, and physical sensations without automatically reacting by smoking.

This pilot randomized controlled trial will evaluate a smoking cessation intervention that combines mindful smoking practice with use of a smartphone-based sensor-band. The study will enroll 30 adults who regularly smoke cigarettes and are motivated to quit smoking or make a quit attempt. Participants will be randomly assigned to an intervention group or a control group, with approximately 15 participants in each group.

Participants in the intervention group will receive a one-hour, one-on-one, in-person mindful smoking guidance session from a certified mindfulness instructor. The session will teach participants to manage cravings mindfully using the RAIN method: Recognize, Accept, Investigate, and Note. Participants will also receive a mindfulness practice video for home practice and in-person instruction from a research assistant on use of the smartphone-based sensor-band. During the 8-week self-management and intervention period, participants in the intervention group will be instructed to practice mindful smoking when they feel a craving to smoke. They will be asked to record their craving level, duration of mindful smoking practice, feelings after mindful smoking, heart rate at the time of craving, heart rate at the end of mindful smoking practice, and daily cigarette smoking activities.

Participants in the control group will receive smoking cessation information published by the American Lung Association, including printed smoking cessation materials. Control group participants will be asked to record their daily cigarette smoking activities.

Data will be collected at baseline, 8 weeks after the intervention begins, and 4 months after the intervention is completed. Feasibility will be assessed by recruitment rate, time to recruit the target sample, intervention uptake rate, attrition rate, and participant satisfaction. Preliminary effectiveness will be assessed by 8-week and 4-month smoking abstinence rates and smoking reduction. Smoking abstinence will be confirmed using exhaled carbon monoxide measurement. The study will also assess stress level, self-control and management level, mindfulness level, heart rate variation, skin temperature, resting heart rate, respiratory rate, and real-time heart rate during craving and mindful smoking practice.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Fang Lei, PhD, MSN, MPH, RN
  • 전화번호: 612-626-7021
  • 이메일: flei@umn.edu

연구 장소

    • Minnesota
      • Minneapolis, Minnesota, 미국, 55455
        • University of Minnesota School of Nursing
        • 연락하다:
          • Fang Lei, PhD, MSN, MPH, RN
          • 전화번호: 612-626-7021
          • 이메일: flei@umn.edu
        • 수석 연구원:
          • Fang Lei, PhD, MSN, MPH, RN

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:

  • Aged 18 years and older
  • Smoking at least 5 cigarettes per day on average over the past 3 months
  • Motivated to quit smoking, indicated by answering "yes" to being interested in quitting smoking or making a quit attempt in the next 30 days
  • Has a functioning Android or iOS smartphone
  • Has a telephone number available for contact

Exclusion Criteria:

  • Recent change in the dosage or type of new medications, if taking medications, or unstable medical situation in the past 3 months
  • Active substance dependence other than nicotine
  • Use of other non-cigarette tobacco products, including e-cigarettes, more than 15 days per month
  • Another household member enrolled in the study
  • Participation in a smoking cessation program in the past 30 days

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Mindful Smoking and Sensor-Band Intervention
Participants in this arm will receive a one-hour, one-on-one mindful smoking guidance session from a certified mindfulness instructor, instruction on use of the smartphone-based sensor-band, a mindfulness practice video for home practice, and smoking cessation information. During the 8-week intervention period, participants will be instructed to practice mindful smoking when they feel a craving to smoke and to record craving level, duration of mindful smoking practice, feelings after practice, heart rate at craving time, heart rate at the end of mindful smoking practice, and daily cigarette smoking activities.
The intervention includes a one-hour, one-on-one mindful smoking guidance session using the RAIN method, which includes Recognize, Accept, Investigate, and Note. Participants will also receive a mindfulness practice video and instructions for using a smartphone-based sensor-band. During the 8-week intervention period, participants will practice mindful smoking when they feel a craving to smoke and will record craving level, duration of practice, feelings after practice, heart rate at craving time, heart rate at the end of mindful smoking practice, and daily smoking activities.
다른 이름들:
  • Quit With Sense
활성 비교기: Smoking Cessation Information Control
Participants in this arm will receive smoking cessation information published by the American Lung Association, including printed smoking cessation materials. Participants will be asked to record their daily cigarette smoking activities in a paper notebook.
Participants will receive smoking cessation information published by the American Lung Association, including printed materials such as The Smoking Health Effects brochure and Top Tips for Quitting Smoking.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Recruitment rate
기간: Baseline / recruitment period, up to 6 months
Recruitment rate will be measured as the proportion of eligible participants who agree to participate in the study.
Baseline / recruitment period, up to 6 months
Time to recruit target sample
기간: Up to 6 months
Time to recruit the target sample will be measured as the duration of time required to recruit the target sample size.
Up to 6 months
Intervention uptake rate
기간: 8 weeks
Intervention uptake rate will be measured as the percentage of participants who complete the intervention.
8 weeks
Attrition rate
기간: Up to 4 months after completion of the 8-week intervention
Attrition rate will be measured as the percentage of participants who drop out before completing the study.
Up to 4 months after completion of the 8-week intervention
Client satisfaction
기간: 8 weeks

Client satisfaction will be assessed using the Satisfaction Feedback Questionnaire, adapted from the Client Satisfaction Questionnaire.

It has 4 questions with ordinal level options. The value of the scare measurement ranges from 0 to 12. Higher score means a higher satisfaction level.

8 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
8-week smoking abstinence rate
기간: 8 weeks
Smoking abstinence at 8 weeks will be measured as the percentage of participants who quit smoking at the 8-week time point. Abstinence will be confirmed by exhaled carbon monoxide measurement level of less than 8 ppm.
8 weeks
8-week smoking reduction
기간: Baseline to 8 weeks
Smoking reduction at 8 weeks will be measured as the reduction in the mean number of cigarettes smoked per day from baseline to the 8-week time point.
Baseline to 8 weeks
4-month smoking abstinence rate
기간: 4 months after completion of the intervention
Smoking abstinence at 4 months after intervention completion will be measured as the percentage of participants who quit smoking at the 4-month follow-up time point. Abstinence will be confirmed by exhaled carbon monoxide measurement level of less than 8 ppm.
4 months after completion of the intervention
4-month smoking reduction
기간: Baseline to 4 months after completion of the intervention
Smoking reduction at 4 months after intervention completion will be measured as the reduction in the mean number of cigarettes smoked per day from baseline to the 4-month follow-up time point.
Baseline to 4 months after completion of the intervention
Stress level
기간: Baseline to 8 weeks
Stress level will be assessed using the Perceived Stress Scale. It has 10 questions with ordinal level options. The value of the scare measurement ranges from 0 to 40. Higher score means a higher stress level.
Baseline to 8 weeks
Self-control and management level
기간: Baseline to 8 weeks

Self-control and management level will be assessed using the Self-control and Management Scale.

It has 16 questions with ordinal level options. The value of the scare measurement ranges from 0 to 80. Higher score means a higher self-control and management level.

Baseline to 8 weeks
Mindfulness level
기간: Baseline to 8 weeks
Mindfulness level will be assessed using the Mindful Attention Awareness Scale. It has 15 questions with ordinal level options. The value of the scare measurement ranges from 0 to 75. Higher score means a higher mindful attention awareness level.
Baseline to 8 weeks
Respiratory Rate Measured by Smartphone-Based Sensor-Band
기간: During the 8-week intervention period
Respiratory rate will be measured in breaths per minute using the smartphone-based sensor-band among intervention group participants.
During the 8-week intervention period
Heart Rate Variability Measured by Smartphone-Based Sensor-Band
기간: During the 8-week intervention period

Physiologic parameters including respiratory rate, heart rate variation, skin temperature, and resting heart rate will be collected using the smartphone-based sensor-band among intervention group participants.

Physiologic parameters including respiratory rate measured by breaths per minute, heart rate variation measured by milliseconds, skin temperature measured by Farehent degree, and resting heart rate measured by heart beats per minute, will be collected using the smartphone-based sensor-band among intervention group participants.

During the 8-week intervention period
Skin Temperature Measured by Smartphone-Based Sensor-Band
기간: During the 8-week intervention period
Skin temperature will be measured in degrees Fahrenheit using the smartphone-based sensor-band among intervention group participants.
During the 8-week intervention period
Resting Heart Rate Measured by Smartphone-Based Sensor-Band
기간: During the 8-week intervention period
Resting heart rate will be measured in beats per minute using the smartphone-based sensor-band among intervention group participants.
During the 8-week intervention period
Heart rate during craving and mindful smoking practice
기간: During the 8-week intervention period
Real-time heart rate will be measured at the time of cigarette craving and at the end of mindful smoking practice among intervention group participants.
During the 8-week intervention period

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Fang Lei, PhD, MSN, MPH, RN, University of Minnesota

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 10월 10일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2027년 12월 31일

연구 등록 날짜

최초 제출

2026년 8월 3일

QC 기준을 충족하는 최초 제출

2026년 8월 24일

처음 게시됨 (실제)

2026년 8월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 9일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

구독하다