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Effects of Expectancy and Mindfulness Instructions on Chronic Pain

2026년 10월 29일 업데이트: Adam Hanley, Florida State University

Measuring the Frame: Examining the Clinical and Neurophysiological Impact of Verbal Expectations and Practice Instructions in a Mindfulness Exercise for Chronic Pain

This randomized 2×2 factorial study will examine how verbal expectancy framing and mindfulness-specific practice instructions influence acute pain and brain activity in adults with chronic pain. Sixty meditation-naïve adults will be assigned to one of four conditions combining positive or negative expectancy framing with either a guided mindfulness exercise or a sham-meditation comparison exercise. Pain intensity, pain unpleasantness, anxiety, desire for pain medication, and mindfulness-related psychological states will be assessed before and immediately after the intervention, while electroencephalography (EEG) will be used to measure changes in brain activity during the exercise. The study is designed to clarify the independent and combined contributions of expectancy and mindfulness-specific instructions to acute pain relief and neurophysiological responses.

연구 개요

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

  • 이름: Carter Minnick
  • 전화번호: 850-270-7844
  • 이메일: cm25bo@fsu.edu

연구 장소

    • Florida
      • Tallahassee, Florida, 미국, 32303
        • Research Building B
        • 연락하다:

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Age 18 years or older
  • Chronic pain, defined as pain occurring on more days than not during the past 3 months
  • Average pain intensity ≥3 on a 0-10 scale during the past week
  • Meditation-naïve, defined as no prior formal or informal meditation training, including MBSR/MBCT, books, or online resources

Exclusion Criteria:

  • Inability to provide informed consent
  • Acute cognitive impairment preventing meaningful participation, in the judgment of the study team
  • Unwillingness to refrain from as-needed pain-relief modalities for 3 hours before the laboratory exercise when safe and feasible
  • Unwillingness to complete all study procedures

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: 요인 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Mindfulness + Positive Expectancy

Standard mindfulness of breath practice to last 15 minutes. Accompanied by either a positive or negative expectancy script directly beforehand.

실험적: Mindfulness + Negative Expectancy

Standard mindfulness of breath practice to last 15 minutes. Accompanied by either a positive or negative expectancy script directly beforehand.

실험적: Sham-Mindfulness + Positive Expectancy

Sham-mindfulness comparator to last 15 min. Participants will be prompted every 3 min to "take a deep breath, as we sit here in mindfulness." Accompanied by either a positive or negative expectancy script directly beforehand.

실험적: Sham-Mindfulness + Negative Expectancy

Sham-mindfulness comparator to last 15 min. Participants will be prompted every 3 min to "take a deep breath, as we sit here in mindfulness." Accompanied by either a positive or negative expectancy script directly beforehand.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pain Intensity
기간: Immediately before and after the 15-minute intervention

Current pain intensity will be assessed using a 0-10 numeric rating scale, with 0 indicating no pain and 10 indicating the worst pain imaginable. Pain intensity will be assessed immediately before and after the intervention; the primary analysis will compare post-intervention ratings across experimental conditions while adjusting for the corresponding pre-intervention rating.

Immediately before and after the 15-minute intervention
Pain Unpleasantness
기간: Immediately before and after the 15-minute intervention

Current pain unpleasantness will be assessed using a 0-10 numeric rating scale, with 0 indicating not at all unpleasant and 10 indicating extremely unpleasant. Pain unpleasantness will be assessed immediately before and after the intervention; the primary analysis will compare post-intervention ratings across experimental conditions while adjusting for the corresponding pre-intervention rating.

Immediately before and after the 15-minute intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Anxiety
기간: Immediately before and after the 15-minute intervention

Current anxiety will be assessed using a 0-10 numeric rating scale, with 0 indicating not at all anxious and 10 indicating extremely anxious. Anxiety will be assessed immediately before and after the intervention; analyses will compare post-intervention ratings across experimental conditions while adjusting for the corresponding pre-intervention rating.

Immediately before and after the 15-minute intervention
Desire for Pain Medication
기간: Immediately before and after the 15-minute intervention

Current desire for pain medication will be assessed using a 0-10 numeric rating scale, with 0 indicating no desire at all and 10 indicating the strongest possible desire. Desire for pain medication will be assessed immediately before and after the intervention; analyses will compare post-intervention ratings across experimental conditions while adjusting for the corresponding pre-intervention rating.

Immediately before and after the 15-minute intervention
Change in Frontal-Midline Theta Power
기간: During the 15-minute intervention relative to the 5-minute pre-intervention resting baseline

EEG frontal-midline theta power in the 4-8 Hz frequency band will be measured over a prespecified frontal-midline region of interest centered on Fz, FCz, and Cz. Mean theta power during the assigned exercise will be expressed relative to the 5-minute eyes-closed resting baseline.

During the 15-minute intervention relative to the 5-minute pre-intervention resting baseline

기타 결과 측정

결과 측정
측정값 설명
기간
Mindfulness
기간: Immediately before and immediately after the 15-minute intervention

State mindfulness will be assessed using the 3-item state version of the Metacognitive Processes of Decentering scale (MPoD-3). Scores will be assessed immediately before and after the intervention to characterize intervention-related changes in state mindfulness.

Immediately before and immediately after the 15-minute intervention
Self-Transcendence
기간: Immediately before and immediately after the 15-minute intervention

State self-transcendence will be assessed using the 3-item state version of the Nondual Awareness Dimensional Assessment (NADA-3). Scores will be assessed immediately before and after the intervention to characterize intervention-related changes in state self-transcendence.

Immediately before and immediately after the 15-minute intervention
Pre-Intervention Treatment Expectancy
기간: Immediately before the expectancy manipulation and 15-minute intervention

Expected effectiveness of the mindfulness exercise for reducing pain will be assessed using a 0-10 numeric rating scale, with 0 indicating not at all effective and 10 indicating extremely effective.

Immediately before the expectancy manipulation and 15-minute intervention
Post-Intervention Treatment Credibility
기간: Immediately after the 15-minute intervention

Perceived credibility or believability of the exercise as a pain-management technique will be assessed using a 0-10 numeric rating scale, with 0 indicating not at all credible and 10 indicating extremely credible.

Immediately after the 15-minute intervention
Number of Participants Reporting an Unpleasant or Adverse Experience
기간: Immediately after the 15-minute intervention

Participants will indicate whether they experienced an unpleasant or adverse experience during the intervention using a Yes/No item. Participants responding Yes will have the opportunity to provide a free-text description of the experience.

Immediately after the 15-minute intervention
Perceived Sociocultural Scaffolding of the Study Encounter
기간: Immediately after the post-exercise processing period, prior to debriefing.

Perceived sociocultural features of the study encounter will be assessed using a 12-item exploratory questionnaire developed for this study. Participants will rate each item on a 1-7 Likert scale ranging from strongly disagree to strongly agree. The questionnaire includes four 3-item subscales assessing: (1) appeal to expert authority, (2) relational alliance-building, (3) ritualization of study procedures, and (4) co-constructed meaning-making. Higher scores on each subscale indicate greater perceived presence of that sociocultural scaffold.

Immediately after the post-exercise processing period, prior to debriefing.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

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)

2027년 1월 15일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2027년 9월 1일

연구 등록 날짜

최초 제출

2026년 10월 29일

QC 기준을 충족하는 최초 제출

2026년 10월 29일

처음 게시됨 (실제)

2026년 11월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 29일

마지막으로 확인됨

2026년 10월 1일

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