Healthy VolunteersS A SNCT07611422
Showers and Stress
A study testing Positive expectation about the effects of cold and warm showers and No expectation regarding the exposure to cold water and/or to warm showers in people with Healthy Volunteers, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Positive expectation about the effects of cold and warm showers and No expectation regarding the exposure to cold water and/or to warm showers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Università Cattolica del Sacro Cuore
Milan
Francesco Pagnini, PhD, +39 339 1942425, francesco.pagnini@unicatt.it
About this study
Official title: Effects of Repeated Cold Shower Exposure on Stress Response: A Psychophysiological Analysis With Expectancy Manipulation
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.
Read the detailed description
The study aims to explore the effect of repeated exposure to cold showers on the ability to respond positively to stressful stimuli. The psychophysiological effects of cold showers will be analyzed in combination with expectancy manipulation, which will be emphasized in only one of the two experimental conditions.
The study adopts a 2×2 factorial experimental design. The sample, consisting of approximately 120 healthy adults, will be randomly assigned to either an experimental group or a control group. Within each group, participants will be further subdivided based on the presence or absence of expectancy manipulation regarding the effectiveness of the intervention on stress management. In the experimental group, participants will be instructed to take warm or lukewarm showers at least four times per week at home, with the addition of a final 30-second exposure to cold water. The control group, on the other hand, will be asked to take only warm or lukewarm showers on a daily basis. The second factor considered is expectancy: one group will receive information designed to induce the expectation that this practice may improve stress management, while the other group will receive no specific information. At baseline assessment, participants will complete questionnaires aimed at evaluating psychological well-being, perceived stress, and quality of life. In addition, they will perform a Stroop task with restricted time limits, which is commonly used as a cognitive stressor, while wearing a heart rate monitoring device (Garmin Vivoactive 5). During the intervention phase, which will last four weeks, participants will keep a daily diary to track whether they performed the shower (cold/warm) and their levels of perceived stress. At the end of the intervention, the same measures administered at baseline will be collected again.
Methods and Instruments
The study involves the use of the following questionnaires:
- Demographic data (gender, age)
- Stress (Perceived Stress Scale, PSS-10)
- Resilience (Resilience Scale for Adults, RSA)
- Psychological well-being (Psychological General Well-Being Index, PGWBI-6) All questionnaires will be administered through the Qualtrics platform.
In addition, during the Stroop task, participants will wear a device (Garmin Vivoactive 5) to monitor physiological activation, assessed via heart rate. The psychophysiological data collection protocol includes a 5-minute resting baseline phase and a recording phase during the Stroop task. A visual analogue scale (VAS) measuring perceived stress will be administered both before and after the Stroop task. These assessments will be conducted both at baseline and at the end of the intervention period (i.e., 4 weeks after the initial assessment). During the intervention phase, participants will complete a daily paper diary, self-reported, including:
Time of the shower Approximate water temperature (hot, lukewarm, cold) For participants in the "cold shower" experimental group: compliance with the task (yes/no) Stress VAS ("today was a…" ranging from "very stressful" to "not stressful at all")
Research Procedure
Participants will be recruited through snowball sampling and word of mouth. The invitation will consist of a message such as: "take part in a study on the relationship between daily showering and well-being." After receiving detailed information about the study in person, those who agree to participate will sign an informed consent form. Participants will then be randomly assigned to one of four groups, in line with the 2×2 factorial design.
During the baseline data collection, participants will complete self-report questionnaires. They will then perform a Stroop task, used as a cognitive stressor, while heart rate will be recorded through a wearable device. Perceived stress will also be measured before and after the Stroop task in order to assess the task-induced stress response.
Depending on group allocation, participants will receive the following instructions:
Group 1 - 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.
Group 2 - 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.
Group 3 - 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.
Group 4 - 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.
The intervention phase will last four weeks, during which participants will keep a daily diary to monitor whether they completed the shower (cold/warm) and their levels of perceived stress.
At the end of the intervention, the same measures administered at baseline will be collected again. During the debriefing, the rationale and research design will be explained and, for Groups 3 and 4, informed consent will be requested again (to confirm or withdraw participation following disclosure of the deception).
Study Objectives
The main objective of the study is to investigate the effect of repeated exposure to cold showers on stress responses, assessed through both psychometric and physiological measures. In particular, the study aims to examine whether the inclusion of brief periods of cold water exposure within a daily routine can influence perceived stress levels, psychological well-being, and physiological responses to stress. A further objective is to explore the role of expectancy in the effectiveness of the intervention, by evaluating the extent to which the presence or absence of information about the beneficial effects of the assigned practice may modulate the observed psychological and physiological outcomes. To this end, the study will compare conditions with and without expectancy manipulation in both the experimental and the control groups.
- Conditions
- Healthy Volunteers
- Being tested
- Positive expectation about the effects of cold and warm showers, No expectation regarding the exposure to cold water and/or to warm showers
- Keywords
- stress, cold shower, resilience, expectations, placebo, physiological monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive expectation about the effects of cold and warm showersBehavioural
Partecipants will be exposed to positive information about the effects of warm and cold showers using a 2x2 factorial design
No expectation regarding the exposure to cold water and/or to warm showersBehavioural
Partecipants will be exposed neutral information about the effects of warm and cold showers using a 2x2 factorial design
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Positive expectation about the effects of cold and warm showers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
Heart rate variability
Change in heart rate while performing the the Stroop test at baseline and at follow-up.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start10 May 2026 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diletta Barbiani, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611422
- Sponsor's protocol ID
- PlaSHOWER_MtBlab
- Acronym
- S A S
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repeated Cold Shower Exposure on Stress Response: A Psychophysiological Analysis With Expectancy Manipulation
- ClinicalTrials.gov ID
- NCT07611422
- Acronym / sponsor ID
- S A S / PlaSHOWER_MtBlab
- Conditions
- Healthy Volunteers
- Keywords
- stress, cold shower, resilience, expectations, placebo, physiological monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study aims to explore the effect of repeated exposure to cold showers on the ability to respond positively to stressful stimuli. The psychophysiological effects of cold showers will be analyzed in combination with expectancy manipulation, which will be emphasized in only one of the two experimental conditions.
The study adopts a 2×2 factorial experimental design. The sample, consisting of approximately 120 healthy adults, will be randomly assigned to either an experimental group or a control group. Within each group, participants will be further subdivided based on the presence or absence of expectancy manipulation regarding the effectiveness of the intervention on stress management. In the experimental group, participants will be instructed to take warm or lukewarm showers at least four times per week at home, with the addition of a final 30-second exposure to cold water. The control group, on the other hand, will be asked to take only warm or lukewarm showers on a daily basis. The second factor considered is expectancy: one group will receive information designed to induce the expectation that this practice may improve stress management, while the other group will receive no specific information. At baseline assessment, participants will complete questionnaires aimed at evaluating psychological well-being, perceived stress, and quality of life. In addition, they will perform a Stroop task with restricted time limits, which is commonly used as a cognitive stressor, while wearing a heart rate monitoring device (Garmin Vivoactive 5). During the intervention phase, which will last four weeks, participants will keep a daily diary to track whether they performed the shower (cold/warm) and their levels of perceived stress. At the end of the intervention, the same measures administered at baseline will be collected again.
Methods and Instruments
The study involves the use of the following questionnaires:
- Demographic data (gender, age)
- Stress (Perceived Stress Scale, PSS-10)
- Resilience (Resilience Scale for Adults, RSA)
- Psychological well-being (Psychological General Well-Being Index, PGWBI-6) All questionnaires will be administered through the Qualtrics platform.
In addition, during the Stroop task, participants will wear a device (Garmin Vivoactive 5) to monitor physiological activation, assessed via heart rate. The psychophysiological data collection protocol includes a 5-minute resting baseline phase and a recording phase during the Stroop task. A visual analogue scale (VAS) measuring perceived stress will be administered both before and after the Stroop task. These assessments will be conducted both at baseline and at the end of the intervention period (i.e., 4 weeks after the initial assessment). During the intervention phase, participants will complete a daily paper diary, self-reported, including:
Time of the shower Approximate water temperature (hot, lukewarm, cold) For participants in the "cold shower" experimental group: compliance with the task (yes/no) Stress VAS ("today was a…" ranging from "very stressful" to "not stressful at all")
Research Procedure
Participants will be recruited through snowball sampling and word of mouth. The invitation will consist of a message such as: "take part in a study on the relationship between daily showering and well-being." After receiving detailed information about the study in person, those who agree to participate will sign an informed consent form. Participants will then be randomly assigned to one of four groups, in line with the 2×2 factorial design.
During the baseline data collection, participants will complete self-report questionnaires. They will then perform a Stroop task, used as a cognitive stressor, while heart rate will be recorded through a wearable device. Perceived stress will also be measured before and after the Stroop task in order to assess the task-induced stress response.
Depending on group allocation, participants will receive the following instructions:
Group 1 - 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.
Group 2 - 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.
Group 3 - 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.
Group 4 - 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.
The intervention phase will last four weeks, during which participants will keep a daily diary to monitor whether they completed the shower (cold/warm) and their levels of perceived stress.
At the end of the intervention, the same measures administered at baseline will be collected again. During the debriefing, the rationale and research design will be explained and, for Groups 3 and 4, informed consent will be requested again (to confirm or withdraw participation following disclosure of the deception).
Study Objectives
The main objective of the study is to investigate the effect of repeated exposure to cold showers on stress responses, assessed through both psychometric and physiological measures. In particular, the study aims to examine whether the inclusion of brief periods of cold water exposure within a daily routine can influence perceived stress levels, psychological well-being, and physiological responses to stress. A further objective is to explore the role of expectancy in the effectiveness of the intervention, by evaluating the extent to which the presence or absence of information about the beneficial effects of the assigned practice may modulate the observed psychological and physiological outcomes. To this end, the study will compare conditions with and without expectancy manipulation in both the experimental and the control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cold shower + Neutral information | Active comparator | Behavioral: No expectation regarding the exposure to cold water and/or to warm showersParticipants 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. |
| Cold shower + Positive expectations | Experimental | Behavioral: Positive expectation about the effects of cold and warm showersParticipants 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. |
| Warm shower + Neutral information | Active comparator | Behavioral: No expectation regarding the exposure to cold water and/or to warm showersParticipants 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. |
| Warm shower + Positive expectations | Experimental | Behavioral: Positive expectation about the effects of cold and warm showersParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive expectation about the effects of cold and warm showersPartecipants will be exposed to positive information about the effects of warm and cold showers using a 2x2 factorial design | Behavioural | Cold shower + Positive expectations, Warm shower + Positive expectations |
| No expectation regarding the exposure to cold water and/or to warm showersPartecipants will be exposed neutral information about the effects of warm and cold showers using a 2x2 factorial design | Behavioural | Cold shower + Neutral information, Warm shower + Neutral information |
Primary outcome
Perceived stress
Time frame: 4 weeks
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.
1 secondary outcome
Heart rate variability
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive expectation about the effects of cold and warm showers and No expectation regarding the exposure to cold water and/or to warm showers in people with Healthy Volunteers, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Pagnini, Professor (+39 3391942425, francesco.pagnini@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.