RecruitingNot ApplicableNCT06827444

The Role of Attention in Modulating the Placebo Effect

Effects of Attention and Placebo Modulation on Cycling Performance: an Experimental Study on Stationary Bikes


Sponsor

Catholic University of the Sacred Heart

Enrollment

128 participants

Start Date

Mar 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This project aims to examine whether these forms of attention to sensory information can modulate the mind-body interaction. This will be demonstrated through a study focused on the placebo effect with attention manipulation. Specifically, the project will focus on the construct of mindful attention to increase the precision of the likelihood and reduce the effects of priors, and on directed attention to modify the position and precision of the likelihood, hypothetically modulating the placebo effect. The study involves recruiting 128 healthy individuals, who will be asked to cycle on an ergometer for approximately 60 minutes, with alternating phases in which attention will be manipulated. After an initial warm-up phase, they will receive a placebo drink, presented as "highly stimulating." An additional group of 32 participants will not receive either the placebo drink or the attentional stimuli, but will undergo the same training cycles. All participants will receive a pre-intervention assessment, and heart rate, emotions, and perceived fatigue will be monitored.


Eligibility

Min Age: 19 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how different types of attention — focusing mindfully on body sensations versus directing attention elsewhere — can influence the placebo effect during exercise, offering new insights into the mind-body connection and pain perception. Healthy adults aged 18 and older who are able to cycle on a stationary bike for approximately 60 minutes and have a medical certificate confirming good health may be eligible, unless they have cardiovascular or gastrointestinal disease, musculoskeletal injuries, or a caffeine allergy. Participants will cycle for an exercise session and receive a drink presented as a stimulant (actually a placebo), while their heart rate, emotions, and perceived effort are monitored. Participation involves one gym visit lasting approximately 60 to 90 minutes, with gym entry costs covered by the study. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPlacebo

Participants will be provided with a chest strap for heart rate measurement (the strap will be washed and disinfected after each session), connected to the Polar Beat app downloaded by the researcher. Subsequently, each participant will perform an initial 10-minute baseline warm-up session (a cadence of 70-80 RPM will be requested). From the cycle ergometer display, values for watts (the amount of work done per second), power (the amount of work done over a certain period of time), and speed (expressed in kilometers per hour) will also be extracted. 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. Heart rate will be continuously recorded throughout the exercise period and during the participant's recovery. Participants will then be randomized to one of the following manipulations.


Locations(1)

Università Cattolica del Sacro Cuore

Milan, Milano, Italy

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NCT06827444


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