Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Effects of Expectancy and Mindfulness Instructions on Chronic Pain

29 oktober 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Carter Minnick
  • Telefoonnummer: 850-270-7844
  • E-mail: cm25bo@fsu.edu

Studie Locaties

  • Verenigde Staten
    • Florida
      • Tallahassee, Florida, Verenigde Staten, 32303
        • Research Building B
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Mindfulness + Positive Expectancy
Gedragsmatig: 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.
Experimenteel: Mindfulness + Negative Expectancy
Gedragsmatig: 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.
Experimenteel: Sham-Mindfulness + Positive Expectancy
Gedragsmatig: 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.
Experimenteel: Sham-Mindfulness + Negative Expectancy
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain Intensity
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Anxiety
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mindfulness
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Florida State University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 januari 2027

Primaire voltooiing (Geschat)

1 september 2027

Studie voltooiing (Geschat)

1 september 2027

Studieregistratiedata

Eerst ingediend

29 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 oktober 2026

Eerst geplaatst (Werkelijk)

4 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

29 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY00008061

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

IPD may be shared with qualified individuals upon request.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren