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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Carter Minnick
- Telefonní číslo: 850-270-7844
- E-mail: cm25bo@fsu.edu
Studijní místa
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Florida
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Tallahassee, Florida, Spojené státy, 32303
- Research Building B
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Kontakt:
- Carter Minnick
- Telefonní číslo: 850-270-7844
- E-mail: cm25bo@fsu.edu
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Mindfulness + Positive Expectancy
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Standard mindfulness of breath practice to last 15 minutes. Accompanied by either a positive or negative expectancy script directly beforehand. |
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Experimentální: Mindfulness + Negative Expectancy
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Standard mindfulness of breath practice to last 15 minutes. Accompanied by either a positive or negative expectancy script directly beforehand. |
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Experimentální: Sham-Mindfulness + Positive Expectancy
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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. |
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Experimentální: Sham-Mindfulness + Negative Expectancy
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain Intensity
Časové okno: Immediately before and after the 15-minute intervention
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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
|
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Pain Unpleasantness
Časové okno: Immediately before and after the 15-minute intervention
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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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Anxiety
Časové okno: Immediately before and after the 15-minute intervention
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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
|
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Desire for Pain Medication
Časové okno: Immediately before and after the 15-minute intervention
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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
|
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Change in Frontal-Midline Theta Power
Časové okno: During the 15-minute intervention relative to the 5-minute pre-intervention resting baseline
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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
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mindfulness
Časové okno: Immediately before and immediately after the 15-minute intervention
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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
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Self-Transcendence
Časové okno: Immediately before and immediately after the 15-minute intervention
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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
|
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Pre-Intervention Treatment Expectancy
Časové okno: Immediately before the expectancy manipulation and 15-minute intervention
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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
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Post-Intervention Treatment Credibility
Časové okno: Immediately after the 15-minute intervention
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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
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Number of Participants Reporting an Unpleasant or Adverse Experience
Časové okno: Immediately after the 15-minute intervention
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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
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Perceived Sociocultural Scaffolding of the Study Encounter
Časové okno: Immediately after the post-exercise processing period, prior to debriefing.
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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.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STUDY00008061
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