ClinicalTrials.gg
RecruitingNCT07611422S A SUpdated May 28, 2026

Showers and Stress

An interventional study of 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 Healthy Volunteers, sponsored by Catholic University of the Sacred Heart. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Catholic University of the Sacred Heart · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • stress
  • cold shower
  • resilience
  • expectations
  • placebo
  • physiological monitoring
03

In context

Lead sponsor

Catholic University of the Sacred Heart is the lead sponsor of 237 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

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 )
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Cold shower + Neutral information

    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

  • Experimental
    Cold shower + Positive expectations

    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

  • Active comparator
    Warm shower + Neutral information

    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

  • Experimental
    Warm shower + Positive expectations

    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

  • BehavioralPositive expectation about the effects of cold and warm showers

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

  • BehavioralNo expectation regarding the exposure to cold water and/or to warm showers

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

06

What researchers measure

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.

    Time frame: 4 weeks

Secondary outcomes

  1. Heart rate variability

    Change in heart rate while performing the the Stroop test at baseline and at follow-up.

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07611422
Responsible party
Diletta Barbiani (Assistant Professor, Catholic University of the Sacred Heart) — Principal investigator
First posted
May 28, 2026
Start date
May 10, 2026 (estimated)
Primary completion
Jul 15, 2026 (estimated)
Completion
Oct 15, 2026 (estimated)
Last update
May 28, 2026

Study contacts

Francesco Pagnini, Professor
Contact
francesco.pagnini@unicatt.it
+39 3391942425
Diletta Barbiani, Assistant professor
Contact
diletta.barbiani@unicatt.it
+39 3338059338

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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