NCT07781670

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2026

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

14 days

First QC Date

August 7, 2026

Last Update Submit

August 20, 2026

Conditions

Keywords

Acute stressElectroencephalographyHeart rate variabilitySkin conductance responseCold Pressor TestEmotional stressPsychophysiologyresilience

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1. During the single experimental session: resting-state baseline (4 minutes) and Cold Pressor Test (up to 3 minutes).

Secondary Outcomes (9)

  • EEG alpha/theta ratio across experimental conditions

    Day 1. During the single experimental session.

  • Heart rate variability across experimental conditions

    Day 1. During the single experimental session

  • Electrodermal activity across experimental conditions

    Day 1. During the single experimental session

  • Skin conductance responses across experimental conditions

    Day 1. During the single experimental session

  • Subjective perceived stress across experimental conditions

    Day 1. Immediately following the relevant experimental conditions during the single experimental session.

  • +4 more secondary outcomes

Study Arms (1)

Experimental Stress Conditions

EXPERIMENTAL

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 TestBehavioral: Negative Autobiographical Memory RecallBehavioral: Affective Picture-Viewing Task

Interventions

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.

Experimental Stress Conditions

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.

Experimental Stress Conditions

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.

Experimental Stress Conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years.
  • Ability to understand the study procedures and provide written informed consent.
  • Sufficient knowledge of the Italian language to understand study instructions and complete the psychological assessments.

You may not qualify if:

  • History of major neurological disorders or other medical conditions that could significantly affect EEG or autonomic measurements.
  • Current severe psychiatric disorder that could interfere with participation in the experimental procedures.
  • Cardiovascular conditions for which exposure to the Cold Pressor Test may be contraindicated.
  • Medical conditions affecting peripheral circulation or sensitivity of the upper limbs that could interfere with or increase the risk associated with the Cold Pressor Test.
  • Current use of medications that may substantially affect autonomic or central nervous system activity, when considered clinically relevant to the study procedures.
  • Presence of wounds, injuries, or other conditions affecting the hand that would prevent safe completion of the Cold Pressor Test.
  • Inability to complete the experimental procedures or provide valid informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pavia

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Teresa Fazia, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants will undergo the same experimental procedures within 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. The order of the experimental stress conditions will be randomized or counterbalanced across participants to reduce potential order, habituation, fatigue, and carry-over effects. Appropriate recovery periods will be introduced between conditions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 24, 2026

Study Start

August 1, 2026

Primary Completion

August 15, 2026

Study Completion

August 15, 2026

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations