Evaluating the Impact of Perceived Control on Placebo Effectiveness: A Comparison Between Classic and Self-Administered Placebo Paradigms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Borg Rating of Perceived Exertion
研究概览
简要总结
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.
详细描述
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 participant's 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."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
The participants did not know which of the three groups they were assigned to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People who have a sports medical certificate
- •People who speak Italian
- •People who give their informed consent
排除标准
- •People who do not have a sports medical certificate
- •People who do not speak Italian
- •People who do not give their informed consent
研究组 & 干预措施
Active Placebo
Following the 10-minute warm-up, participants will be presented with a hypoglycemic energy drink (actually a ginger-flavored beverage) to be taken as needed, explicitly stating, "You have 10 ml of this particularly energizing, hypoglycemic, caffeine-based drink, which is designed to reduce fatigue and improve performance. You can decide when to take it." The researcher will note the time of consumption.
干预措施: Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drink (Other)
Passive Placebo
Following the 10-minute warm-up, they will be presented with a hypoglycemic energy drink (actually a ginger-flavored beverage) to be taken as needed, explicitly stating, "Before proceeding, consume this particularly energizing, hypoglycemic, caffeine-based drink, which is designed to reduce fatigue and improve performance."
干预措施: Neutral ginger-flavored drink (Other)
Control
Following the 10-minute warm-up, they will be presented with a mineral salt-based drink (actually a ginger-flavored beverage), described as such ("Before proceeding, consume this mineral salt-based drink"), which the participant will consume before continuing with the proposed exercise.
干预措施: Neutral ginger-flavored drink (Other)
结局指标
主要结局
Borg Rating of Perceived Exertion
时间窗: 2 hours
The Borg Rating of Perceived Exertion (RPE) scale is a subjective tool used to measure the perceived intensity of physical effort, fatigue and exertion during exercise. The scale ranges from 6 to 20, where 6 represents minimal effort (such as sitting) and 20 represents the maximal possible effort.
Socio-demographic variables
时间窗: 2 hours
Gender, age, smoking status, and number of cigarettes smoked per day. Additionally, factors such as alcohol use (frequency), physical activity (frequency and type), level of education, marital status.
Positive and Negative Affect Schedule
时间窗: 2 hours
The Positive and Negative Affect Schedule (PANAS) is a psychological tool developed by Watson, Clark, and Tellegen in 1988, designed to measure positive and negative affect. It comprises 20 items, with 10 items each for positive affect (PA) and negative affect (NA). The PA scale assesses the extent to which an individual feels enthusiastic, active, and alert, while the NA scale measures the degree of distress and aversive emotional states such as anger, guilt, and fear. Participants rate each emotion on a 1 to 5 scale, indicating the extent to which they have experienced these feelings over a specified time frame. High PA scores reflect elevated positive emotions, whereas high NA scores indicate elevated negative emotions.
次要结局
- Distance traveled(2 hours)
研究者
Eleonora Volpato
Clinical Professor
Fondazione Don Carlo Gnocchi Onlus