NCT04130126

Brief Summary

Considering the beneficial individual and environmental effects, investigators set out to replicate the recent study on the effects of taking cold showers on sickness absence, illness days and subjective well-being and to assess both the acceptability of taking cold showers as well as its effects on sickness absence and illness days as well as well-being, sleep quality, skin and hair appearance for a period of 3 months in a population of healthy and volunteering participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 24, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
2 years until next milestone

Study Start

First participant enrolled

October 26, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

September 24, 2019

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change of sickness absence

    Sickness absence will be assessed at baseline and then monthly for 3 months. Participants are asked to retrospectively indicate the total number of days of absence from their work due to sickness. If participants indicate sickness absence over five days, they are asked for the reason.

    Assessed at baseline and then monthly for 3 months

  • Change in number of illness days

    Illness days will be assessed at baseline and then monthly for 3 months. Participants are asked to retrospectively indicate the number of days that they have had symptoms of illness, cold or flu during the last month. If participants indicate illness over five days, they are asked for the reason.

    Assessed at baseline and then monthly for 3 months

Secondary Outcomes (9)

  • World Health Organization (WHO) Five Well-Being Index

    Assessed at baseline and then monthly for 3 months

  • Questionnaire for positive aspects of well-being in adults

    Assessed at baseline and then monthly for 3 months

  • International Physical Activity Questionnaire

    Assessed at baseline and then monthly for 3 months

  • Pittsburgh Sleep Quality Index

    Assessed at baseline and then monthly for 3 months

  • Skin quality questionnaire

    Assessed at baseline and then monthly for 3 months

  • +4 more secondary outcomes

Study Arms (2)

Warm showers

NO INTERVENTION

Participants in the warm showers condition are instructed to continue their normal warm showers throughout the study

Cold showers

EXPERIMENTAL

Participants in the cold showers condition will be asked to take cold showers over a time period of 3 months

Behavioral: Taking cold showers

Interventions

Showering behaviour

Cold showers

Eligibility Criteria

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

You may qualify if:

  • healthy participants between 18 and 65 years of age
  • no cold shower taken on a regular basis by participants

You may not qualify if:

  • pregnant or lactating women
  • subjects with cardiac, pulmonary or any other severe disease by self-report.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel

Basel, Switzerland

Location

Study Officials

  • Jens Gaab, Prof. Dr.

    Faculty for Psychology at the University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2019

First Posted

October 17, 2019

Study Start

October 26, 2021

Primary Completion

March 17, 2023

Study Completion

December 31, 2023

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations