"How Awareness and Subjectivity Modulate the Placebo Effect"
NCT Number: NCT06533137
Acronym: AS-m-P
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: 3 Placebo Groups in a Cycle Ergometer Session With Healthy Participants
Interventions: OTHER: Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drink|OTHER: Neutral ginger-flavored drink|OTHER: Neutral ginger-flavored drink
Sponsor: Fondazione Don Carlo Gnocchi Onlus
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-11-28
Completion Date: 2024-08-01
Locations: Don Gnocchi Foundation, Milan, 20148, Italy

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.

Primary Outcome Measures: Borg Rating of Perceived Exertion, The Borg Rating of Perceived Exertion (RPE) scale is a subjective tool used to measure the perceived intensity of physical effort, fatigue and exertion during exercise. The scale ranges from 6 to 20, where 6 represents minimal effort (such as sitting) and 20 represents the maximal possible effort., 2 hours|Positive and Negative Affect Schedule, The Positive and Negative Affect Schedule (PANAS) is a psychological tool developed by Watson, Clark, and Tellegen in 1988, designed to measure positive and negative affect. It comprises 20 items, with 10 items each for positive affect (PA) and negative affect (NA). The PA scale assesses the extent to which an individual feels enthusiastic, active, and alert, while the NA scale measures the degree of distress and aversive emotional states such as anger, guilt, and fear. Participants rate each emotion on a 1 to 5 scale, indicating the extent to which they have experienced these feelings over a specified time frame. High PA scores reflect elevated positive emotions, whereas high NA scores indicate elevated negative emotions., 2 hours|Socio-demographic variables, Gender, age, smoking status, and number of cigarettes smoked per day. Additionally, factors such as alcohol use (frequency), physical activity (frequency and type), level of education, marital status., 2 hours
Secondary Outcome Measures: Distance traveled, kilometers per hour, 2 hours