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"How Awareness and Subjectivity Modulate the Placebo Effect"

NCT06533137 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-11-12

No results posted yet for this study

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.

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

It is a neutral ginger-flavored drink with no energizing properties, although it was presented as "particularly energizing, hypoglycemic, caffeine-based, and designed to reduce fatigue and improve performance.

OTHER

Neutral ginger-flavored drink

A neutral ginger flavoured drink described as an energizing, hypoglycemic, caffeine-based drink, which is designed to reduce fatigue and improve performance.

OTHER

Neutral ginger-flavored drink

A neutral ginger-flavored beverage bescribed as a mineral salt-based drink

Sponsors & Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2022-12-01
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06533137 on ClinicalTrials.gov