"How Awareness and Subjectivity Modulate the Placebo Effect"
NCT ID: NCT06533137
Last Updated: 2024-11-12
Study Results
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Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2022-11-28
2024-12-31
Brief Summary
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Detailed Description
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Through an anonymous link on Qualtrics, participants will initially complete a scale of perceived exertion (Borg Rating of Perceived Exertion) and the PANAS. They will be provided with a chest strap (Garmin HRM-Pro) to monitor heart rate and respiratory rate (the strap will be washed and disinfected after each session), connected to a device capable of reading the data (Garmin Forerunner 245).
Subsequently, each participant will perform a first session, consisting of a 10-minute warm-up (a cadence of 70-80 RPM will be requested). At the end of this first session, in all three conditions, participants will be asked to perform a modified 10-minute maximal test using a classic protocol. Participants will be asked to pedal "with full force" for 10 minutes. During the test, no visual or verbal feedback will be provided. Participants will be blind to the cycle ergometer screen, so the data will not influence their behavior. Respiratory physiological measures and heart rate will be continuously recorded throughout the exercise period and during the participant's recovery. Although the test condition is identical across the three groups, they differ in the type of manipulation they will receive:
Active placebo group. Following the 10-minute warm-up, participants will be presented with a hypoglycemic energy drink (actually a ginger-flavored drink) to be consumed as needed, explicitly stating, "You have at your disposal 10 ml of this particularly energizing, hypoglycemic, caffeine-based drink, designed to reduce fatigue and improve performance. You can decide when it is time to consume it." The researcher will note the moment of consumption.
Passive placebo group. Following the 10-minute warm-up, participants will be presented with a hypoglycemic energy drink (actually a ginger-flavored drink) to be consumed as needed, explicitly stating, "Before continuing, consume this particularly energizing, hypoglycemic, caffeine-based drink, designed to reduce fatigue and improve performance."
Control group. Following the 10-minute warm-up, participants will be presented with a mineral-based drink (actually a ginger-flavored drink), described as such ("Before continuing, consume this mineral-based drink"), which the participant will consume before proceeding with the proposed exercise.
At the end of the exercise, the pre-intervention assessment (Borg CR10 and PANAS) will be repeated, and a perceived control scale (Locus of Control of Behaviour) will also be administered. Upon completion, a debriefing will be provided with an overall explanation of the theory and expected results. Along with the final debriefing, which reveals the deception used (the drink has no actual fatigue-reducing properties), participants will be asked to re-sign the informed consent form.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Active Placebo
Following the 10-minute warm-up, participants will be presented with a hypoglycemic energy drink (actually a ginger-flavored beverage) to be taken as needed, explicitly stating, "You have 10 ml of this particularly energizing, hypoglycemic, caffeine-based drink, which is designed to reduce fatigue and improve performance. You can decide when to take it." The researcher will note the time of consumption.
Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drink
It is a neutral ginger-flavored drink with no energizing properties, although it was presented as "particularly energizing, hypoglycemic, caffeine-based, and designed to reduce fatigue and improve performance.
Passive Placebo
Following the 10-minute warm-up, they will be presented with a hypoglycemic energy drink (actually a ginger-flavored beverage) to be taken as needed, explicitly stating, "Before proceeding, consume this particularly energizing, hypoglycemic, caffeine-based drink, which is designed to reduce fatigue and improve performance."
Neutral ginger-flavored drink
A neutral ginger flavoured drink described as an energizing, hypoglycemic, caffeine-based drink, which is designed to reduce fatigue and improve performance.
Control
Following the 10-minute warm-up, they will be presented with a mineral salt-based drink (actually a ginger-flavored beverage), described as such ("Before proceeding, consume this mineral salt-based drink"), which the participant will consume before continuing with the proposed exercise.
Neutral ginger-flavored drink
A neutral ginger-flavored beverage bescribed as a mineral salt-based drink
Interventions
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Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drink
It is a neutral ginger-flavored drink with no energizing properties, although it was presented as "particularly energizing, hypoglycemic, caffeine-based, and designed to reduce fatigue and improve performance.
Neutral ginger-flavored drink
A neutral ginger flavoured drink described as an energizing, hypoglycemic, caffeine-based drink, which is designed to reduce fatigue and improve performance.
Neutral ginger-flavored drink
A neutral ginger-flavored beverage bescribed as a mineral salt-based drink
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* People who speak Italian
* People who give their informed consent
Exclusion Criteria
* People who do not speak Italian
* People who do not give their informed consent
18 Years
ALL
Yes
Sponsors
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Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Eleonora Volpato
Clinical Professor
Locations
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Don Gnocchi Foundation
Milan, , Italy
Countries
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Facility Contacts
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References
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Pires FO, Dos Anjos CAS, Covolan RJM, Fontes EB, Noakes TD, St Clair Gibson A, Magalhaes FH, Ugrinowitsch C. Caffeine and Placebo Improved Maximal Exercise Performance Despite Unchanged Motor Cortex Activation and Greater Prefrontal Cortex Deoxygenation. Front Physiol. 2018 Aug 17;9:1144. doi: 10.3389/fphys.2018.01144. eCollection 2018.
Craig AR, Franklin JA, Andrews G. A scale to measure locus of control of behaviour. Br J Med Psychol. 1984 Jun;57(2):173-80. doi: 10.1111/j.2044-8341.1984.tb01597.x.
Friston K. The free-energy principle: a unified brain theory? Nat Rev Neurosci. 2010 Feb;11(2):127-38. doi: 10.1038/nrn2787. Epub 2010 Jan 13.
Geers AL, Helfer SG, Weiland PE, Kosbab K. Expectations and placebo response: a laboratory investigation into the role of somatic focus. J Behav Med. 2006 Apr;29(2):171-8. doi: 10.1007/s10865-005-9040-5. Epub 2005 Dec 23.
Other Identifiers
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UCSC_21102022
Identifier Type: -
Identifier Source: org_study_id
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