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van CCT (UK)

van CCT (UK)

Training positive expectations for health: Verbal suggestion versus imagery.

- candidate number13384
- NTR NumberNTR3641
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-sep-2012
- Secondary IDsNL38953.091.12 / 2012/009 CMO
- Public TitleTraining positive expectations for health: Verbal suggestion versus imagery.
- Scientific TitleTraining positive expectations for health: Verbal suggestion versus imagery.
- hypothesisIt is hypothesized that both positive verbal suggestions regarding an inert substance and a positive imagery exercise result in a lower sensitivity to physical sensations (pain, itch, and fatigue) than neutral verbal suggestions and/or neutral imagery.
- Healt Condition(s) or Problem(s) studiedHealthy subjects
- Inclusion criteria1. Age above 18 years;
2. Fluent in Dutch language.
- Exclusion criteria1. Severe physical or psychological morbidity (e.g., heart and lung diseases, or DSM-IV psychiatric disorders) that would adversely affect participation;
2. Chronic pain, itch, or fatigue complaints, allergic rhinitis or asthma at present or in the past;
3. Use of beta-blockers or other medication that influence heart rate; use of pacemaker;
4. Inadequate health for physical exercise (Physical Activity Readiness Questionnaire);
5. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2012
- planned closingdate31-dec-2013
- Target number of participants116
- InterventionsExpectation effects are induced by means of:
1. Positive versus neutral verbal suggestions on the effectiveness of a substance that is, unknown to the participants, inert;
2. A positive versus neutral imagery exercise in which participants focus on either their best possible health in the future or on a typical day.
- Primary outcomeThe primary endpoint of this study is the effectiveness of the expectation manipulations in affecting sensitivity to pain, itch, and fatigue, i.e., the difference between the conditions in sensitivity to pain, itch, and fatigue (standardized sum score) after the expectation manipulations, as rated on visual analogue scales (VAS).
- Secondary outcomePhysiological responses (e.g., heart rate and skin conductance) and the role of individual characteristics (e.g., optimism) are explored.
- TimepointsOne timepoint. Participants take place in one experimental session during which the primary outcome measures are assessed once after the expectation manipulations.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Radboud University Nijmegen Medical Centre
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Organization for Scientific Research (NWO)
- PublicationsN/A
- Brief summaryIn the present project, the effects of two expectation manipulations (verbal suggestions regarding an inert substance and an imagery exercise) on self-reported sensitivity to physical sensations of pain, itch, and fatigue is examined. Additionally, the effects on physiological responses and the role of individual characteristics (e.g., optimism) will be explored.
- Main changes (audit trail)18-jul-2014: "Kort na aanvang van de dataverzameling werd het fenomeen van Raynaud als exclusiecriterium toegevoegd om eventuele risico’s voor de deelnemers en mogelijke negatieve gevolgen hiervan op de resultaten te voorkomen. De reden voor de latere toevoeging van dit exclusiecriterium was dat zich eerder nog geen mensen hadden aangemeld met het fenomeen van Raynaud.” - AB
- RECORD27-sep-2012 - 18-jul-2014

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