Placebo EffectNCT06827444
The Role of Attention in Modulating the Placebo Effect
A study of Placebo Effect and Attention, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Placebo Effect, Attention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 7 Mar 2024to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- known cardiovascular diseases, gastrointestinal diseases, musculoskeletal injuries, upper respiratory tract infections;
- allergy and/or intolerance to caffeine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Università Cattolica del Sacro Cuore
Milan, Milano, 20123
Francesca NA Grosso, MD, 3405594270 ext. 39, francesca.grosso@unicatt.it
About this study
Official title: Effects of Attention and Placebo Modulation on Cycling Performance: an Experimental Study on Stationary Bikes
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.
- Conditions
- Placebo Effect, Attention
- Being tested
- Placebo
- Keywords
- Placebo, Bayesiana approach, Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Other: Placebo |
| Control Group | Active comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Numeric Rating Scale 0-10, where 10 indicates maximum fatigue.
Measured: 30 minutes
Secondary outcomes (2)
Heart rate
Heart rate beats, assessed with Polar H10 chest strap
Measured: 30 minutes
Perceived efficacy of the energy drink
Numeric Rating Scale 0-10, where 10 is the most effective.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start7 Mar 2024
- Primary completion12 Dec 2024
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placebo EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pagnini, Catholic University of the Sacred Heart
- Investigators
- Francesca NA Grosso, MD, Study director, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827444
- Sponsor's protocol ID
- Università Cattolica del Sacro
- Status last verified
- Jan 2025
- First submitted
- 27 Jun 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Attention and Placebo Modulation on Cycling Performance: an Experimental Study on Stationary Bikes
- ClinicalTrials.gov ID
- NCT06827444
- Acronym / sponsor ID
- Università Cattolica del Sacro
- Conditions
- Placebo Effect, Attention
- Keywords
- Placebo, Bayesiana approach, Mindfulness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: Placebo |
| Control Group | Active comparator | Other: Placebo |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- known cardiovascular diseases, gastrointestinal diseases, musculoskeletal injuries, upper respiratory tract infections;
- allergy and/or intolerance to caffeine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipants 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. | Other | Control Group, Placebo group |
Primary outcome
Fatigue
Time frame: 30 minutes
Numeric Rating Scale 0-10, where 10 indicates maximum fatigue.
2 secondary outcomes
Heart rate
Time frame: 30 minutes
Perceived efficacy of the energy drink
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca NA Grosso, MD study director
Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Placebo Effect and Attention, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca NA Grosso, MD (3405594270 ext. 39, francesca.grosso@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.