Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533137
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
How Awareness and Subjectivity Modulate the Placebo Effect
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Impact of Perceived Control on Placebo Effectiveness A Comparison Between Classic and Self-Administered Placebo Paradigms
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AS-m-P
Brief 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
Detailed Description:
The experimental phase of the study will take place at the gym of the IRCCS Fondazione Don Gnocchi Participants will be invited to attend without having consumed caffeine or alcohol in the previous 6 hours and will be informed that the study consists of a session on the cycle ergometer hence they will be asked to wear appropriate clothing
Through an anonymous link on Qualtrics participants will initially complete a scale of perceived exertion Borg Rating of Perceived Exertion and the PANAS They will be provided with a chest strap Garmin HRM-Pro to monitor heart rate and respiratory rate the strap will be washed and disinfected after each session connected to a device capable of reading the data Garmin Forerunner 245
Subsequently each participant will perform a first session consisting of a 10-minute warm-up a cadence of 70-80 RPM will be requested At the end of this first session in all three conditions participants will be asked to perform a modified 10-minute maximal test using a classic protocol Participants will be asked to pedal with full force for 10 minutes 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 Respiratory physiological measures and heart rate will be continuously recorded throughout the exercise period and during the participants recovery Although the test condition is identical across the three groups they differ in the type of manipulation they will receive
Active placebo group Following the 10-minute warm-up participants will be presented with a hypoglycemic energy drink actually a ginger-flavored drink to be consumed as needed explicitly stating You have at your disposal 10 ml of this particularly energizing hypoglycemic caffeine-based drink designed to reduce fatigue and improve performance You can decide when it is time to consume it The researcher will note the moment of consumption
Passive placebo group Following the 10-minute warm-up participants will be presented with a hypoglycemic energy drink actually a ginger-flavored drink to be consumed as needed explicitly stating Before continuing consume this particularly energizing hypoglycemic caffeine-based drink designed to reduce fatigue and improve performance
Control group Following the 10-minute warm-up participants will be presented with a mineral-based drink actually a ginger-flavored drink described as such Before continuing consume this mineral-based drink which the participant will consume before proceeding with the proposed exercise
At the end of the exercise 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 Upon completion a debriefing will be provided with an overall explanation of the theory and expected results Along with the final debriefing which reveals the deception used the drink has no actual fatigue-reducing properties participants will be asked to re-sign the informed consent form
Through an anonymous link on Qualtrics participants will initially complete a scale of perceived exertion Borg Rating of Perceived Exertion and the PANAS They will be provided with a chest strap Garmin HRM-Pro to monitor heart rate and respiratory rate the strap will be washed and disinfected after each session connected to a device capable of reading the data Garmin Forerunner 245
Subsequently each participant will perform a first session consisting of a 10-minute warm-up a cadence of 70-80 RPM will be requested At the end of this first session in all three conditions participants will be asked to perform a modified 10-minute maximal test using a classic protocol Participants will be asked to pedal with full force for 10 minutes 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 Respiratory physiological measures and heart rate will be continuously recorded throughout the exercise period and during the participants recovery Although the test condition is identical across the three groups they differ in the type of manipulation they will receive
Active placebo group Following the 10-minute warm-up participants will be presented with a hypoglycemic energy drink actually a ginger-flavored drink to be consumed as needed explicitly stating You have at your disposal 10 ml of this particularly energizing hypoglycemic caffeine-based drink designed to reduce fatigue and improve performance You can decide when it is time to consume it The researcher will note the moment of consumption
Passive placebo group Following the 10-minute warm-up participants will be presented with a hypoglycemic energy drink actually a ginger-flavored drink to be consumed as needed explicitly stating Before continuing consume this particularly energizing hypoglycemic caffeine-based drink designed to reduce fatigue and improve performance
Control group Following the 10-minute warm-up participants will be presented with a mineral-based drink actually a ginger-flavored drink described as such Before continuing consume this mineral-based drink which the participant will consume before proceeding with the proposed exercise
At the end of the exercise 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 Upon completion a debriefing will be provided with an overall explanation of the theory and expected results Along with the final debriefing which reveals the deception used the drink has no actual fatigue-reducing properties participants will be asked to re-sign the informed consent form
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None