An interventional study of Mindfulness of Breath Practice (15 min) and Sham-Mindfulness Practice in Chronic Pain, sponsored by Florida State University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Florida State University · Not applicable, Interventional, and Treatment
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.
3,008 studies on the registry are indexed under Chronic Pain; 710 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 2,218 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Florida State University is the lead sponsor of 247 studies on the registry; 47 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: Mindfulness of Breath Practice (15 min)
Behavioral: Mindfulness of Breath Practice (15 min)
Behavioral: Sham-Mindfulness Practice
Behavioral: Sham-Mindfulness Practice
Standard mindfulness of breath practice to last 15 minutes. Accompanied by either a positive or negative expectancy script directly beforehand.
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.
Pain Intensity
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.
Time frame: Immediately before and after the 15-minute intervention
Pain Unpleasantness
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.
Time frame: Immediately before and after the 15-minute intervention
Anxiety
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.
Time frame: Immediately before and after the 15-minute intervention
Desire for Pain Medication
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.
Time frame: Immediately before and after the 15-minute intervention
Change in Frontal-Midline Theta Power
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.
Time frame: During the 15-minute intervention relative to the 5-minute pre-intervention resting baseline
Mindfulness
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.
Time frame: Immediately before and immediately after the 15-minute intervention
Self-Transcendence
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.
Time frame: Immediately before and immediately after the 15-minute intervention
Pre-Intervention Treatment Expectancy
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.
Time frame: Immediately before the expectancy manipulation and 15-minute intervention
Post-Intervention Treatment Credibility
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.
Time frame: Immediately after the 15-minute intervention
Number of Participants Reporting an Unpleasant or Adverse Experience
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.
Time frame: Immediately after the 15-minute intervention
Perceived Sociocultural Scaffolding of the Study Encounter
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.
Time frame: Immediately after the post-exercise processing period, prior to debriefing.
Plan to share: Yes — IPD may be shared with qualified individuals upon request.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Sep 2027, 7 months later.
Of 1,217 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's planned 7 months is below that.
Counting every sponsor, half of 1,306 studies reached it within 21 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.