NCT07611422

Brief Summary

The study investigates whether repeated exposure to cold showers can improve the ability to cope with and respond to stress. In particular, it examines both the psychophysiological effects of cold showers and the role of expectations regarding their effectiveness. The research adopts a 2×2 experimental design with approximately 120 healthy adults, randomly assigned to either an experimental group or a control group, and further divided based on the presence or absence of information emphasizing the potential benefits of the intervention. The experimental group takes warm or lukewarm showers with a final 30-second exposure to cold water at least four times per week, while the control group takes only warm or lukewarm showers. In parallel, some participants receive positive information about the effectiveness of the intervention for stress management, while others receive no specific information. At baseline and at the end of the study, participants complete questionnaires assessing perceived stress, psychological well-being, and quality of life, along with a physiological measure and a cognitive stress task (Stroop test with heart rate monitoring). During the four-week intervention period, participants keep a daily diary recording shower habits and perceived stress levels.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
4mo left

Started May 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 Progress23%
May 2026Oct 2026

First Submitted

Initial submission to the registry

May 5, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

May 10, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 5, 2026

Last Update Submit

May 20, 2026

Conditions

Keywords

stresscold showerresilienceexpectationsplacebophysiological monitoring

Outcome Measures

Primary Outcomes (1)

  • Perceived stress

    Perceived stress will be assessed using the Perceived Stress Scale (PSS-10) to evaluate changes in perceived stress from baseline to the end of the study, including during exposure to the Stroop task. Total scores range from 0 to 40, with higher scores indicating greater perceived stress and therefore a worse outcome.

    4 weeks

Secondary Outcomes (1)

  • Heart rate variability

    4 weeks

Study Arms (4)

Cold shower + Neutral information

ACTIVE COMPARATOR

Participants will be asked to end their shower, at least four times per week, at home (or in other locations of their choice), with at least 30 seconds of cold water exposure, preferably very cold. No specific rationale will be provided to support this request.

Behavioral: No expectation regarding the exposure to cold water and/or to warm showers

Cold shower + Positive expectations

EXPERIMENTAL

Participants will be asked to end their shower, at least four times per week, at home (or in other locations of their choice), with at least 30 seconds of cold water exposure, preferably very cold. This request will be supported by an explanation regarding the potential role of cold showers in promoting resilience and reducing stress.

Behavioral: Positive expectation about the effects of cold and warm showers

Warm shower + Neutral information

ACTIVE COMPARATOR

Participants will be asked to take warm showers at least four times per week, at home or in other locations of their choice. No specific rationale will be provided to support this request.

Behavioral: No expectation regarding the exposure to cold water and/or to warm showers

Warm shower + Positive expectations

EXPERIMENTAL

Participants will be asked to take warm showers at least four times per week, at home or in other locations of their choice. This request will be supported by an explanation regarding the potential role of warm showers in promoting resilience and reducing stress.

Behavioral: Positive expectation about the effects of cold and warm showers

Interventions

Partecipants will be exposed to positive information about the effects of warm and cold showers using a 2x2 factorial design

Cold shower + Positive expectationsWarm shower + Positive expectations

Partecipants will be exposed neutral information about the effects of warm and cold showers using a 2x2 factorial design

Cold shower + Neutral informationWarm shower + Neutral information

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants will be eligible for the study if they meet the following criteria:
  • Age ≥ 18 years
  • Good general health status, self-reported and/or certified by a medical document (e.g., general medical certificate or sports medical clearance)
  • Willingness to participate for the full duration of the study (4 weeks)
  • Ability to understand and independently complete questionnaires and study diaries
  • Signed informed consent

You may not qualify if:

  • Participants will be excluded from the study if they present:
  • Uncompensated cardiovascular, neurological, or endocrine conditions considered relevant to stress or cold exposure tolerance
  • Medical conditions contraindicating cold exposure (e.g., Raynaud's phenomenon, cold urticaria, etc.)
  • Pregnancy
  • Use of medications that may interfere with stress responses (e.g., beta-blockers, anxiolytics, systemic corticosteroids)
  • Acute or unstable psychiatric disorders
  • Inability to comply with the experimental protocol or complete study materials
  • Concurrent participation in other studies involving stress or physiological regulation interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Cattolica del Sacro Cuore

Milan, Italy

RECRUITING

Central Study Contacts

Francesco Pagnini, Professor

CONTACT

Diletta Barbiani, Assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 28, 2026

Study Start

May 10, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

May 28, 2026

Record last verified: 2026-05

Locations