Mindset Interventions to Facilitate Taking Cold Showers

Psychological Clinical Trial

— MICS  

Official title:

Mindset Interventions to Facilitate Taking Cold Showers: A Randomized Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05497713
• Other study ID #: eknz2022-00952
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this trial is to determine whether mindsets sustain the feasibility of taking cold showers over a 3-month period. Secondary objectives are to determine potential effects on physical and mental well-being, sleep quality, skin and hair appearance, perceived illness, and related sickness absences from work.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 476
• Est. completion date: December 2024
• Est. primary completion date: February 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

The investigators will include

• healthy participants between 18 and 65 years of age,

• which do not take cold shower on a regular basis.

• As there are no known gender differences, participants of both female and male sex are included.

Exclusion Criteria:

The investigators will exclude

• pregnant or lactating women by self-report and

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

Related Conditions & MeSH terms

• Psychological

Intervention

Other:
• Mindsets
The primary objective of this trial is to determine whether mindsets sustain the feasibility of taking cold showers over a 3-month period.

Locations

Country	Name	City	State
Switzerland	University of Basel Faculty of Psychology Division for Clinical Psychology and Psychotherapy	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
Jens Gaab

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Showering behaviour concerning frequency (Baseline)	Participants will be asked how often they showered during the last week.	Baseline
Primary	Showering behaviour concerning duration (Baseline)	Participants will be asked how long they showered for during the last week.	Baseline
Primary	Showering behaviour concerning motivation (Baseline)	Participants will be asked their motivation for taking cold showers during the last week.	Baseline
Primary	Showering behaviour concerning frequency (Week 1)	Participants will be asked how often they showered during the last week.	Week 1
Primary	Showering behaviour concerning frequency (Week 2)	Participants will be asked how often they showered during the last week.	Week 2
Primary	Showering behaviour concerning frequency (Week 3)	Participants will be asked how often they showered during the last week.	Week 3
Primary	Showering behaviour concerning frequency (Week 4)	Participants will be asked how often they showered during the last week.	Week 4
Primary	Showering behaviour concerning frequency (Week 5)	Participants will be asked how often they showered during the last week.	Week 5
Primary	Showering behaviour concerning frequency (Week 6)	Participants will be asked how often they showered during the last week.	Week 6
Primary	Showering behaviour concerning frequency (Week 7)	Participants will be asked how often they showered during the last week.	Week 7
Primary	Showering behaviour concerning frequency (Week 8)	Participants will be asked how often they showered during the last week.	Week 8
Primary	Showering behaviour concerning frequency (Week 9)	Participants will be asked how often they showered during the last week.	Week 9
Primary	Showering behaviour concerning frequency (Week 10)	Participants will be asked how often they showered during the last week.	Week 10
Primary	Showering behaviour concerning frequency (Week 11)	Participants will be asked how often they showered during the last week.	Week 11
Primary	Showering behaviour concerning frequency (Week 12)	Participants will be asked how often they showered during the last week.	Week 12
Primary	Showering behaviour concerning duration (Week 1)	Participants will be asked how long they showered for during the last week.	Week 1
Primary	Showering behaviour concerning duration (Week 2)	Participants will be asked how long they showered for during the last week.	Week 2
Primary	Showering behaviour concerning duration (Week 3)	Participants will be asked how long they showered for during the last week.	Week 3
Primary	Showering behaviour concerning duration (Week 4)	Participants will be asked how long they showered for during the last week.	Week 4
Primary	Showering behaviour concerning duration (Week 5)	Participants will be asked how long they showered for during the last week.	Week 5
Primary	Showering behaviour concerning duration (Week 6)	Participants will be asked how long they showered for during the last week.	Week 6
Primary	Showering behaviour concerning duration (Week 7)	Participants will be asked how long they showered for during the last week.	Week 7
Primary	Showering behaviour concerning duration (Week 8)	Participants will be asked how long they showered for during the last week.	Week 8
Primary	Showering behaviour concerning duration (Week 9)	Participants will be asked how long they showered for during the last week.	Week 9
Primary	Showering behaviour concerning duration (Week 10)	Participants will be asked how long they showered for during the last week.	Week 10
Primary	Showering behaviour concerning duration (Week 11)	Participants will be asked how long they showered for during the last week.	Week 11
Primary	Showering behaviour concerning duration (Week 12)	Participants will be asked how long they showered for during the last week.	Week 12
Primary	Showering behaviour concerning motivation (Week 1)	Participants will be asked their motivation for taking cold showers during the last week.	Week 1
Primary	Showering behaviour concerning motivation (Week 2)	Participants will be asked their motivation for taking cold showers during the last week.	Week 2
Primary	Showering behaviour concerning motivation (Week 3)	Participants will be asked their motivation for taking cold showers during the last week.	Week 3
Primary	Showering behaviour concerning motivation (Week 4)	Participants will be asked their motivation for taking cold showers during the last week.	Week 4
Primary	Showering behaviour concerning motivation (Week 5)	Participants will be asked their motivation for taking cold showers during the last week.	Week 5
Primary	Showering behaviour concerning motivation (Week 6)	Participants will be asked their motivation for taking cold showers during the last week.	Week 6
Primary	Showering behaviour concerning motivation (Week 7)	Participants will be asked their motivation for taking cold showers during the last week.	Week 7
Primary	Showering behaviour concerning motivation (Week 8)	Participants will be asked their motivation for taking cold showers during the last week.	Week 8
Primary	Showering behaviour concerning motivation (Week 9)	Participants will be asked their motivation for taking cold showers during the last week.	Week 9
Primary	Showering behaviour concerning motivation (Week 10)	Participants will be asked their motivation for taking cold showers during the last week.	Week 10
Primary	Showering behaviour concerning motivation (Week 11)	Participants will be asked their motivation for taking cold showers during the last week.	Week 11
Primary	Showering behaviour concerning motivation (Week 12)	Participants will be asked their motivation for taking cold showers during the last week.	Week 12
Secondary	WHO Five Well-Being Index	The WHO-5 is a short questionnaire designed to measure well-being. The WHO-5 consists of five questions. The answers are given on a six-level scale (0 - 5, where 0 represents "No time at all" and 5 "All the time"). The raw value is obtained by adding the answers. The raw value ranges from 0 to 25, where 0 is the lowest quality of life and 25 is the highest quality of life. The percentage value of 0 -100 is obtained by multiplying by 4. The percentage value 0 denotes the worst state of health, 100 the best. The processing time is less than one minute. Example: In the last 4 weeks I was happy and in a good mood.	All secondary outcomes will be assessed at baseline and then monthly for 3 months.
Secondary	Questionnaire for positive aspects of well-being in adults	The FEW 16 is a psychological self-evaluation procedure for the assessment of positive aspects of well-being in adults. The FEW 16 consists of 16 questions, of which 4 questions each are assigned to one of the following four scales: Ability to work under pressure, vitality, enjoyment, inner peace. The answers are given on a 6-level scale (1 - 6, where 6 represents "Does not apply at all" and 1 "Is absolutely true"). The processing time is estimated at five to ten minutes by adding up the 16 items you get an overall result between 16 - 96, whereas a lower overall result shows a higher physical wellbeing. Example: There's hardly anything that can upset me.	All secondary outcomes will be assessed at baseline and then monthly for 3 months.
Secondary	International Physical Activity Questionnaire	The IPAQ is a short questionnaire designed to measure physical activity. The IPAQ consists of six questions, of which 3 questions each are assigned to one of the following two scales: Strong physical exertion and light physical exertion. Either you have to tick an answer or you will be asked for a time in hours and minutes per week. The processing time is estimated at three minutes. Example: If you are thinking about physical activities where you are at least a little out of breath, such as running, hiking, dancing, gardening or many sports, how many days a week do you do physical activities of this kind?	All secondary outcomes will be assessed at baseline and then monthly for 3 months.
Secondary	Pittsburgh Sleep Quality Index	The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. The questionnaire offers seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totalling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Example: How tired are you during the day?	All secondary outcomes will be assessed at baseline and then monthly for 3 months.
Secondary	Skin quality questionnaire	The SQQ is a short self-report questionnaire that assesses hand and skin quality. The measure consists of 4 items, whereas they measure appearance, intactness, moisture content and sensation on a 7-level scale (1-7), where higher scores denote a healthier quality of skin. The processing time is less than one minute each. Example: Appearance: Abnormal: redness, stains, rash. Normal: no redness, stains or rashes.	All secondary outcomes will be assessed at baseline and then monthly for 3 months.
Secondary	Sickness absence and illness days	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 and to indicate the number of days that they have had symptoms of illness, cold or flu during the last month. If participants indicate sickness absence or illness over five days, they are asked for the reason.	All secondary outcomes will be assessed at baseline and then monthly for 3 months.