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Can positive expectations have negative effects on pain?


- candidate number27151
- NTR NumberNTR6384
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mei-2017
- Secondary IDsCEP17-0314/152 Psychology Ethics Committee Leiden University
- Public TitleCan positive expectations have negative effects on pain?
- Scientific TitleThe effects of the under prediction of pain on pain experience
- ACRONYM
- hypothesisWe test the effect of a verbal suggestion providing an under prediction of the pain intensity of upcoming heat stimuli as compared to a correct prediction of the intensity to assess the possible occurrence of contrasts effects (i.e., more intense pain after the under prediction of pain than after the correct prediction of pain). In total, 8 heat stimuli of approximately 8 seconds each will be given, all at the same intensity that was found to be moderately painful during calibration. Primary hypothesis Participants will experience more intense pain during the first moderately intense heat stimulus directly after a suggestion that the stimuli will not be painful (under prediction) as compared to after a suggestion that the stimuli will be moderately painful (correct prediction). Secondary hypothesis Participants will expect to experience more intense pain during a second heat stimulus when they have experienced a moderately intense stimulus after a suggestion that the stimuli will not be painful (under prediction) as compared to after a suggestion that the stimuli will be moderately painful (correct prediction). Exploratory Several additional assessments are done for exploratory analyses, including assessments of expected and experienced pain during each of the other heat stimuli; pain unpleasantness, certainty of the pain expectation, fear of the stimulus, heart rate, and skin conductance for each heat stimulus; trust in the experimenter, state anxiety, and e.g., awareness of the discrepancy between the verbal suggestion and the pain experience after all stimuli; and individual characteristics (e.g., optimism).
- Healt Condition(s) or Problem(s) studiedHealthy subjects
- Inclusion criteria1. 18-30 years
2. Good understanding of written and spoken English
- Exclusion criteria1. Severe physical or psychological morbidity (e.g., heart and lung diseases, or DSM psychiatric disorders) that could adversely affect study participation
2. Chronic ( 6 months) pain complaints at present or in the past
3. Current use of medication
4. Use of pacemaker
5. Pregnancy
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-mrt-2017
- planned closingdate30-sep-2017
- Target number of participants82
- InterventionsParticipants in the experimental condition receive a verbal suggestion stating that the upcoming heat stimuli are expected to be experienced as non-painful (under prediction).
Participants in the control condition receive a verbal suggestion stating that the upcoming heat stimuli are expected to be experienced as moderately painful (correct prediction).
- Primary outcomeExperienced pain intensity during the first heat stimulus of moderate intensity directly following the verbal suggestion, as assessed on a numerical rating scale (0 no pain C 10 worst pain imaginable).
- Secondary outcomeExpected pain intensity of the second heat stimulus of moderate intensity following the verbal suggestion, as assessed on a numerical rating scale (0 no pain C 10 worst pain imaginable).
- TimepointsAfter filling in online screening questionnaires, eligible participants take part in one experimental session during which the primary outcome is assessed once after the verbal suggestion. For exploratory purposes, 7 additional heat stimuli of the same intensity are given.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Kaya J. Peerdeman
- CONTACT for SCIENTIFIC QUERIES Kaya J. Peerdeman
- Sponsor/Initiator Leiden University
- Funding
(Source(s) of Monetary or Material Support)
Leiden University
- Publications
- Brief summaryWe test the effect of a verbal suggestion providing an under prediction of the pain intensity of upcoming heat stimuli as compared to a correct prediction of the intensity to assess the possible occurrence of contrasts effects (i.e., more intense pain after the under prediction of pain than after the correct prediction of pain).
- Main changes (audit trail)
- RECORD1-mei-2017 - 21-jun-2017


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