Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06827444

The Role of Attention in Modulating the Placebo Effect

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

19 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università Cattolica del Sacro Cuore

Milan, Milano, 20123, Italy

Location status: Recruiting

Location contact

Francesca NA Grosso, MD

CONTACT

[email protected]

3405594270 ext. 39

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons (18+) in good health, verified by presenting a medical certificate (sporting, competitive or non-competitive, or of good health).
  • Be available to go to a gym. If not enrolled, the cost of admission is borne by the project.

Exclusion criteria

  • known cardiovascular diseases, gastrointestinal diseases, musculoskeletal injuries, upper respiratory tract infections;
  • allergy and/or intolerance to caffeine.

Treatment and study plan

Placebo

Other

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.

Primary outcomes

  1. Fatigue

    Time frame: 30 minutes

    Numeric Rating Scale 0-10, where 10 indicates maximum fatigue.

Secondary outcomes

  1. Heart rate

    Time frame: 30 minutes

    Heart rate beats, assessed with Polar H10 chest strap

  2. Perceived efficacy of the energy drink

    Time frame: 30 minutes

    Numeric Rating Scale 0-10, where 10 is the most effective.

Other outcomes

  1. Mindfulness

    Time frame: Once, at the baseline (pre-experiment)

    The Mindfulness Awareness Attention Scale (MAAS) is a widely used self-report measure designed to assess an individual's level of mindfulness, particularly focusing on present-moment awareness and attention. Developed by MacKillop and Anderson (2007), the scale evaluates the frequency of mindful states in everyday life, emphasizing the ability to remain attentive to and aware of current experiences. The MAAS has been extensively applied in both clinical and non-clinical settings to explore the relationship between mindfulness and various psychological and behavioral outcomes, such as stress reduction, emotional regulation, and overall well-being.

  2. Anxiety

    Time frame: Once, at the baseline (pre-experiment)

    The Beck Anxiety Inventory (BAI) is a widely used self-report measure designed to assess the severity of anxiety symptoms. Developed by Beck et al. (1988), the scale focuses on somatic and subjective symptoms of anxiety, such as nervousness, fear, and physical sensations like sweating or dizziness. The BAI is commonly used in both clinical and research settings to screen for anxiety disorders, monitor symptom changes over time, and evaluate the effectiveness of therapeutic interventions. Its reliability and ease of use make it a valuable tool for assessing anxiety across diverse populations.

  3. Stress

    Time frame: Once, at the baseline (pre-experiment)

    The Perceived Stress Scale (PSS) is a widely used self-report tool designed to measure the level of stress an individual perceives in their daily life. Developed by Cohen et al. (1994), the scale evaluates how unpredictable, uncontrollable, and overwhelming respondents find their life circumstances over the past month. The PSS is often employed in both research and clinical settings to assess stress levels, explore its impact on health outcomes, and monitor changes following interventions aimed at stress reduction. Its versatility and simplicity make it suitable for diverse populations and contexts.

  4. Optimism

    Time frame: Once, at the baseline (pre-experiment)

    The Life Orientation Test - Revised (LOT-R) is a psychological assessment tool designed to measure individual differences in dispositional optimism. Developed by Scheier et al. (1994), the LOT-R evaluates the extent to which individuals hold positive expectations about future outcomes. This self-report scale is widely used in both research and clinical settings to examine the role of optimism in psychological well-being, health outcomes, and coping strategies. Its concise format and strong psychometric properties make it a valuable instrument for exploring optimism across various populations and contexts.

  5. Cognitive flexibility

    Time frame: Once, at the baseline (pre-experiment)

    The Cognitive Flexibility Scale (CFS) is a self-report instrument designed to assess an individual's capacity to adapt their thinking and behavior in response to changing situations or environments. Developed by Martin and Rubin (1995), the scale evaluates key aspects of cognitive flexibility, including the ability to consider multiple perspectives, generate alternative solutions, and cope effectively with challenges. This tool is widely used in research and clinical settings to explore how cognitive flexibility influences problem-solving, resilience, and overall psychological well-being. Its straightforward design ensures usability across diverse populations.

  6. Personality traits

    Time frame: Once, at the baseline (pre-experiment)

    The Big Five Inventory-10 (BFI-10) is a brief self-report measure designed to assess the five major dimensions of personality: openness, conscientiousness, extraversion, agreeableness, and neuroticism. Developed as a shortened version of the original Big Five Inventory, it includes only 10 items, making it ideal for contexts where time is limited, while still providing reliable and valid results (Rammstedt & John, 2007). Despite its brevity, the BFI-10 retains the ability to capture key personality traits and is widely used in psychological research and applied settings to gain insights into individual differences.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca NA Grosso, MD

CONTACT

[email protected]

3405594270 ext. 39

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.