The Role of Attention in Modulating the Placebo Effect

Not Applicable

Recruiting

• Conditions: Placebo Effect; Attention

• Registration Number: NCT06827444
• Lead Sponsor: Catholic University of the Sacred Heart

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-07
• Study First Submitted: 2024-06-27
• Primary Completion: 2024-12-12
• Status Verified: 2025-01
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fatigue	30 minutes	Numeric Rating Scale 0-10, where 10 indicates maximum fatigue.

Secondary Outcome Measures

Name	Time	Method
Heart rate	30 minutes	Heart rate beats, assessed with Polar H10 chest strap
Perceived efficacy of the energy drink	30 minutes	Numeric Rating Scale 0-10, where 10 is the most effective.

Trial Locations

Locations (1)

Università Cattolica del Sacro Cuore; 🇮🇹 Milan, Milano, Italy