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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Mindfulness of Breath Practice (15 min); Behavioral: Sham-Mindfulness Practice

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carter Minnick; Phone Number: 850-270-7844; Email: cm25bo@fsu.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32303
      • Research Building B
      • Contact: Carter Minnick; Phone Number: 850-270-7844; Email: cm25bo@fsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness + Positive Expectancy	Behavioral: Mindfulness of Breath Practice (15 min); Standard mindfulness of breath practice to last 15 minutes. Accompanied by either a positive or negative expectancy script directly beforehand.
Experimental: Mindfulness + Negative Expectancy	Behavioral: Mindfulness of Breath Practice (15 min); Standard mindfulness of breath practice to last 15 minutes. Accompanied by either a positive or negative expectancy script directly beforehand.
Experimental: Sham-Mindfulness + Positive Expectancy	Behavioral: Sham-Mindfulness Practice; 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.
Experimental: Sham-Mindfulness + Negative Expectancy	Behavioral: Sham-Mindfulness Practice; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Immediately before and after the 15-minute intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	During the 15-minute intervention relative to the 5-minute pre-intervention resting baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Immediately after the post-exercise processing period, prior to debriefing.

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: October 29, 2026
• First Submitted That Met QC Criteria: October 29, 2026
• First Posted (Actual): November 4, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: October 29, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; Mindfulness; Neuroimaging; Expectations
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: STUDY00008061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

IPD may be shared with qualified individuals upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No