An interventional study of Cold Pressor Test and Negative Autobiographical Memory Recall in Stress and Acute Stress, sponsored by University of Pavia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by University of Pavia · Not applicable, Interventional, and Basic science
This study aims to investigate neurophysiological, autonomic, and subjective responses to different acute physical and emotional stress-inducing conditions using a within-subject repeated-measures design.
Participants will complete four experimental conditions: a resting-state baseline, a Cold Pressor Test, a negative autobiographical memory recall task, and an affective picture-viewing task using stimuli selected from the Nencki Affective Picture System (NAPS). The order of the experimental stress conditions will be randomized or counterbalanced to minimize potential order and carry-over effects.
Electroencephalographic (EEG) and autonomic activity will be recorded throughout the experimental session. Autonomic measures will include heart rate (HR), heart rate variability (HRV), electrodermal activity (EDA), and skin conductance responses (SCR). Subjective levels of stress, anxiety, and pain will be assessed using visual analogue scales (VAS).
Participants will also complete validated psychological measures assessing resilience, perceived stress, and state and trait anxiety, together with the Tower of London task as a behavioral measure of executive planning.
The primary objective is to characterize the modulation of EEG alpha-band activity during acute physical stress, with the main comparison focusing on the Cold Pressor Test relative to resting-state baseline. Secondary and exploratory objectives include comparing cortical, autonomic, and subjective responses across experimental conditions and investigating whether individual psychological characteristics and executive functioning are associated with differences in psychophysiological stress responses.
The study will employ a within-subject repeated-measures design to investigate neurophysiological, autonomic, subjective, and cognitive responses to different acute physical and emotional stress-inducing conditions.
Each participant will complete four experimental conditions within a single experimental session: (1) a resting-state baseline, (2) a Cold Pressor Test, (3) a negative autobiographical memory recall task, and (4) an affective picture-viewing task using stimuli selected from the Nencki Affective Picture System (NAPS). The order of the experimental stress conditions will be randomized or counterbalanced across participants to reduce systematic order, habituation, fatigue, and carry-over effects. Appropriate recovery periods will be introduced between conditions.
During the resting-state baseline, participants will remain seated and relaxed with their eyes closed for four minutes. This condition will provide a reference measure of spontaneous cortical and autonomic activity.
During the Cold Pressor Test, participants will immerse one hand in an ice-water bath and will be instructed to maintain the immersion for as long as tolerable, up to a maximum of three minutes. Participants will be allowed to withdraw their hand at any time if the stimulation becomes intolerable. Actual immersion duration will be recorded as an index of pain tolerance.
During the negative autobiographical memory recall condition, participants will be instructed to select a personally painful or distressing autobiographical memory and focus on its emotional and experiential aspects for three minutes while seated with their eyes closed. No specific autobiographical event will be suggested by the researcher.
During the affective picture-viewing condition, participants will view negative and neutral images selected from the NAPS. Each trial will consist of a fixation period followed by presentation of an affective or neutral image. The presentation order will be randomized.
Electroencephalographic (EEG) and autonomic activity will be recorded throughout the experimental session. Autonomic measures will include heart rate (HR), heart rate variability (HRV), electrodermal activity (EDA), and skin conductance responses (SCR). Particular attention will be given to EEG alpha-band activity over frontal, parietal, and frontoparietal regions.
Subjective ratings of stress, anxiety, and pain will be obtained using visual analogue scales (VAS) following the relevant experimental conditions. Participants will also complete validated psychological questionnaires assessing resilience, perceived stress using the 10-item Perceived Stress Scale (PSS-10), and state and trait anxiety using the State-Trait Anxiety Inventory (STAI-Y).
Executive functioning will be assessed using the 12-problem version of the Tower of London task. The task will be administered after the resting-state assessment and will provide a behavioral measure of executive planning and related higher-order cognitive processes.
The primary objective of the study is to characterize the modulation of EEG alpha-band activity associated with acute physical stress, with the main comparison focusing on the Cold Pressor Test relative to the resting-state baseline.
Secondary objectives include characterizing autonomic responses, including HRV, EDA, and SCR, and subjective stress, anxiety, and pain responses across the experimental conditions. Additional analyses will examine EEG activity across the different experimental conditions.
Exploratory analyses will investigate whether individual psychological characteristics, executive functioning, and pain tolerance are associated with differences in cortical, autonomic, and subjective responses to acute stress. Multivariate exploratory analyses may also be conducted to integrate EEG, autonomic, cognitive, and psychological measures and characterize individual patterns of psychophysiological stress response.
844 studies on the registry are indexed under Stress, Psychological; 136 are open to participants now.
This study's planned enrollment of 30 is below the median of 84 across 688 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →University of Pavia is the lead sponsor of 144 studies on the registry; 39 are open to participants now.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Clinically significant
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Participants will complete a single experimental session including a resting-state baseline, a Cold Pressor Test, a negative autobiographical memory recall task, and an affective picture-viewing task. EEG and autonomic activity will be continuously recorded throughout the experimental session. The order of the experimental stress conditions will be randomized or counterbalanced across participants, with appropriate recovery periods between conditions.
Behavioral: Cold Pressor Test · Behavioral: Negative Autobiographical Memory Recall · Behavioral: Affective Picture-Viewing Task
Participants will immerse one hand in an ice-water bath and will be instructed to maintain the immersion for as long as tolerable, up to a maximum of three minutes. Participants may withdraw their hand at any time if the stimulation becomes intolerable. The actual duration of hand immersion will be recorded as an index of pain tolerance. EEG and autonomic activity will be continuously recorded during the task.
Participants will be instructed to select a personally painful or distressing autobiographical memory and focus on its emotional and experiential aspects for three minutes while seated with their eyes closed. No specific autobiographical event will be suggested by the researcher. EEG and autonomic activity will be continuously recorded during the task.
Participants will view negative and neutral images selected from the Nencki Affective Picture System (NAPS). Each trial will consist of a 10-second fixation period followed by a 30-second image presentation. Images will be presented in randomized order while EEG and autonomic activity are continuously recorded.
Change in EEG alpha-band activity during the Cold Pressor Test compared with resting-state baseline
EEG alpha-band activity will be quantified from predefined scalp regions, with particular attention to frontal, parietal, and frontoparietal regions. The primary outcome will be the within-participant change in alpha-band EEG activity during the Cold Pressor Test relative to the resting-state baseline.
Time frame: Day 1. During the single experimental session: resting-state baseline (4 minutes) and Cold Pressor Test (up to 3 minutes).
EEG alpha/theta ratio across experimental conditions
The EEG alpha/theta power ratio will be calculated as the ratio between alpha-band and theta-band EEG power in predefined scalp regions and compared within participants across the resting-state baseline, Cold Pressor Test, negative autobiographical memory recall, and affective picture-viewing conditions. The alpha/theta ratio is a dimensionless measure.
Time frame: Day 1. During the single experimental session.
Heart rate variability across experimental conditions
Heart rate variability (HRV) will be derived from cardiac recordings and compared across the resting-state baseline, Cold Pressor Test, negative autobiographical memory recall, and affective picture-viewing conditions.
Time frame: Day 1. During the single experimental session
Electrodermal activity across experimental conditions
Electrodermal activity (EDA) will be continuously recorded throughout the experimental session as an index of sympathetic autonomic activation. EDA will be compared within participants across the resting-state baseline, Cold Pressor Test, negative autobiographical memory recall, and affective picture-viewing conditions.
Time frame: Day 1. During the single experimental session
Skin conductance responses across experimental conditions
Skin conductance responses (SCR) will be derived from electrodermal recordings obtained continuously during the experimental session. The number and frequency of measurable SCRs will be quantified and compared within participants across the resting-state baseline, Cold Pressor Test, negative autobiographical memory recall, and affective picture-viewing conditions. Higher values indicate a greater frequency of phasic electrodermal responses.
Time frame: Day 1. During the single experimental session
Subjective perceived stress across experimental conditions
Subjective perceived stress will be assessed using a Visual Analogue Scale for Stress (VAS-Stress), ranging from 0 to 100, where 0 indicates no perceived stress and 100 indicates the highest level of perceived stress imaginable. Higher scores indicate greater perceived stress. VAS-Stress scores will be compared within participants across the relevant experimental conditions.
Time frame: Day 1. Immediately following the relevant experimental conditions during the single experimental session.
Subjective anxiety across experimental conditions
Subjective anxiety will be assessed using a Visual Analogue Scale for Anxiety (VAS-Anxiety), ranging from 0 to 100, where 0 indicates no anxiety and 100 indicates the highest level of anxiety imaginable. Higher scores indicate greater subjective anxiety. VAS-Anxiety scores will be compared within participants across the relevant experimental conditions.
Time frame: Day 1. Immediately following the relevant experimental conditions during the single experimental session.
Subjective pain intensity following the Cold Pressor Test
Subjective pain intensity will be assessed using a Visual Analogue Scale for Pain (VAS-Pain), ranging from 0 to 100, where 0 indicates no pain and 100 indicates the worst pain imaginable. Higher scores indicate greater perceived pain intensity.
Time frame: Day 1. Immediately following the Cold Pressor Test during the single experimental session.
Pain tolerance during the Cold Pressor Test
Pain tolerance will be assessed as the duration of hand immersion in the ice-water bath, measured in seconds, ranging from 0 to 180 seconds. Higher values indicate greater pain tolerance. Participants may withdraw their hand at any time, and the Cold Pressor Test will be terminated after a maximum of 180 seconds.
Time frame: Day 1. During the Cold Pressor Test within the single experimental session.
Percentage of stimuli eliciting a skin conductance response during affective picture viewing
The percentage of affective picture-viewing trials eliciting a measurable skin conductance response (SCR) will be calculated as the number of trials associated with a measurable SCR divided by the total number of evaluable trials, multiplied by 100. Scores range from 0% to 100%, with higher values indicating a greater proportion of stimuli eliciting a measurable electrodermal response.
Time frame: Day 1. During the affective picture-viewing condition within the single experimental session.
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Started Aug 2026 (actual). Primary completion is estimated for Aug 2026, 0 months after the start.
Of 457 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 0 months is below that.
Counting every sponsor, half of 470 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
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