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Recruiting NCT06908447

Cold Water and Decision-Making

No phase Interventional Behavior Stress Quality of Life Psychological Wellbeing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cold-water immersion, Warm-water immersion (Control).
Who it may be relevant to
Registry conditions: Behavior, Stress, Quality of Life, Psychological Wellbeing. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Voluntary Cold-Water Immersion Effects on Value-Based Choice

Overview

The behavioral within-subject cross-over design study "CoVa" aims to investigate the effect of a short-term full-body cold-water immersion vs. warm-water immersion control on value-based choice, psychological well-being, and peripheral physiology.

Detailed description

This randomized within-subject cross-over design behavioral study in cognitive neuroscience will employ an acute peripheral physiological intervention, i.e., a 10-minute full-body cold-water (10-16°C) immersion vs. a control condition (10 min @ 30- 36°C water) on two visits separated by approx. 30 days.

Forty eligible female and male participants will be subject to a head-out full-body cold-water immersion or a warm-water condition (control) on two visits. Participants will perform resting-state and task-based non-invasive electrophysiological recordings of the heart, pulse, respiration, skin conductance, and pupil, will undergo thermographic imaging, pre- and post-immersion blood sampling (4 time points), engage in two computer-based decision-making tasks (reinforcement learning task, risk decision-making task), a brief food choice task, and receive a battery of psychometric questionnaires. The visits are separated by approximately 30 days and do not differ in their timeline except for the primary intervention, i.e., cold vs warm-water immersion, and the medical screening on visit 1.

Interventions

  • Behavioral Cold-water immersion
    Single 10-minute acute full-body head-out single arm-out cold-water immersion at 10-16°C on the experimental day
  • Behavioral Warm-water immersion (Control)
    Single 10-minute acute full-body head-out single arm-out cold-water immersion at 30-36°C on the experimental day

Primary outcome measures

  • Risk propensity [Time frame: On day 1 and after 30 days]
  • Behavioral range adaptation [Time frame: On day 1 and after 30 days]
  • Food choice [Time frame: On day 1 and after 30 days]
  • Heart-rate variability [Time frame: On day 1 and after 30 days]
  • Heart rate [Time frame: On day 1 and after 30 days]
  • Respiration rate [Time frame: On day 1 and after 30 days]
  • Relative amplitude of the respiratory signal [Time frame: On day 1 and after 30 days]
  • Event-related skin conductance responses [Time frame: On day 1 and after 30 days]
  • Tonic skin conductance [Time frame: On day 1 and after 30 days]
  • Pupil dilation [Time frame: On day 1 and after 30 days]
Secondary outcome measures (8)
  • Trait autonomy questionnaire [Time frame: On day 1 and after 30 days]
  • Emotion regulation questionnaire [Time frame: On day 1 and after 30 days]
  • Causality orientation questionnaire [Time frame: On day 1 and after 30 days]
  • Delay discounting questionnaire [Time frame: On day 1 and after 30 days]
  • Interoceptive awareness questionnaire [Time frame: On day 1 and after 30 days]
  • Generalized self-efficacy questionnaire [Time frame: On day 1 and after 30 days]
  • Trait and state anxiety questionnaire [Time frame: On day 1 and after 30 days]
  • Well-being questionnaire [Time frame: On day 1 and after 30 days]

Eligibility criteria

Inclusion criteria

  • 18-40 years of age
  • Consent to participate
  • Fluency in German
  • Physically and mentally healthy
  • BMI 18-30 kg/m2
  • Normal day-night rhythm

Exclusion criteria

  • Raynaud syndrome
  • Cold urticaria
  • High resting heart rate (>160 beats per minute)
  • Acute infection
  • Diagnosed current or former illnesses of
  • Brain and mind
  • Heart and blood circulation
  • Gastrointestinal system
  • Endocrine system
  • Other serious past or present medical conditions
  • Wearing of medical devices (e.g., pacemaker)
  • Fear of blood, needles, or phlebotomy
  • Allergies to plasters, gels, and other medical equipment
  • Allergies to commercially available liquid meals (e.g., shakes, yfood Labs GmbH)
  • Recurrent intake of medication which affect metabolism
  • Regular nicotine consumption (e.g., vaping, cigarettes)
  • Excessive alcohol consumption (>14 servings/week)
  • Recent illegal drug consumption (within 2 weeks prior)
  • Strong mental or physical stress
  • Excessive exercise (>2 h high-intensity exercise/day)
  • Pregnancy or breastfeeding
  • Inability to wear skin-exposing swimwear, e.g., for religious reasons
  • Affinity for winter swimming, cryotherapy, breathwork (>3 times/year)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

Germany · 1 center
  • German Institute of Human Nutrition Potsdam-Rehbruecke — Nuthetal

Identifiers

NCT: NCT06908447 · CoVa · 01GP2210C

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗