Effects of Expectancy and Mindfulness Instructions on Chronic Pain
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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Carter Minnick
- 電話番号：850-270-7844
- メール：cm25bo@fsu.edu
研究場所
-
-
Florida
-
Tallahassee、Florida、アメリカ、32303
- Research Building B
-
コンタクト：
- Carter Minnick
- 電話番号：850-270-7844
- メール：cm25bo@fsu.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Mindfulness + Positive Expectancy
|
Standard mindfulness of breath practice to last 15 minutes. Accompanied by either a positive or negative expectancy script directly beforehand. |
|
実験的：Mindfulness + Negative Expectancy
|
Standard mindfulness of breath practice to last 15 minutes. Accompanied by either a positive or negative expectancy script directly beforehand. |
|
実験的：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. |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain Intensity
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Anxiety
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mindfulness
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。