Clinical Trial

"How Awareness and Subjectivity Modulate the Placebo Effect"

Study acronym: AS-m-P
Recruiting
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Summary
This study consists of a three-group experimental design (active placebo, passive placebo, control) with the primary outcome being perceived fatigue during a cycle ergometer training session. A pre-intervention assessment is planned, in which participants complete (online, via Qualtrics) the Borg Rating of Perceived Exertion (Borg CR10 Scale) and the Positive and Negative Affect Schedule (PANAS; scale for assessing positive and negative emotions). During the intervention, which consists of a cycle ergometer session with 10 minutes of warm-up and 10 minutes of more intense activity, participants will wear a heart rate monitor (Garmin HRM-Pro) to record heart rate and respiratory rate. In addition to these outcomes, distance traveled and speed achieved, extracted from the cycle ergometer data, will also be considered. At the end of the session, 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-07-29.
Trial Details
NCT Number NCT06533137
Lead Sponsor Fondazione Don Carlo Gnocchi ETS
Conditions 3 Placebo Groups in a Cycle Ergometer Session With Healthy Participants
Enrollment 84 participants
Start Date 2022-11-28
Primary Completion 2022-12-01 (estimated)
Study Completion 2024-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-12