- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06125639
Effects of Sauna Bathing on Sleep, Mood and Stress
November 4, 2023 updated by: University School of Physical Education, Krakow, Poland
Sauna bathing is a popular, low-cost, and easily accessible type of whole-body thermotherapy that has been used for social, religious, health, and hygienic reasons for thousands of years.
There is strong evidence to support the various physiological and psychological benefits of sauna bathing.
The positive effects of regular sauna use have been explained by a number of mechanisms of action, including increased cardiac output, reduced peripheral vascular resistance and other physiological changes in cardiovascular parameters such as decreased systolic and/or diastolic blood pressure.
Additionally, the psychological impact of sauna bathing may occur due to a combination of factors that include the release of endorphins, relaxation, placebo effects, and psychological and social interactions that likely occur around frequent sauna activity.
Taken together, it is possible that acute and regular sauna bathing may impact sleep quality.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Kraków, Poland, 31-571
- Recruiting
- University School of Physical Education in Cracow
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Contact:
- Anna Radon
- Phone Number: 48 12 6831142
- Email: anna.radon@awf.krakow.pl
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- good general health assessed by physician
- written consent to participate
Exclusion Criteria:
- medication or dietary supplements, which could potentially impact the study outcomes
- history of sleep or neurological disorders
- regular sauna use
- professional athlete
- shift worker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
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Experimental: Sauna Group
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Participants will take part in 9 evening sauna bathing session over the course of 3 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Sleep - Time in bed
Time Frame: 5 weeks
|
Total time spent in bed during the night assessed by sleep radar
|
5 weeks
|
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Objective Sleep - Sleep-onset latency
Time Frame: 5 weeks
|
The time it takes from when the participant intends to go to sleep and actually starts to sleep assessed by sleep radar
|
5 weeks
|
|
Objective Sleep - Total sleep time
Time Frame: 5 weeks
|
Total sleep time obtained from sleep onset to time at wake-up assessed by sleep radar
|
5 weeks
|
|
Objective Sleep - Light sleep
Time Frame: 5 weeks
|
Total amount of time in light sleep assessed by sleep radar
|
5 weeks
|
|
Objective Sleep - Deep sleep
Time Frame: 5 weeks
|
Total amount of time in deep sleep assessed by sleep radar
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5 weeks
|
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Objective Sleep - REM sleep
Time Frame: 5 weeks
|
Total amount of time in REM sleep assessed by sleep radar
|
5 weeks
|
|
Objective Sleep - Sleep efficiency
Time Frame: 5 weeks
|
The percentage of total sleep time to lights off and leaving bed assessed by sleep radar
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Sleep Quality assessed by Karolinska Sleep Diary
Time Frame: 5 weeks
|
5 weeks
|
|
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Stress level assessed by VAS scale
Time Frame: 5 weeks
|
VAS scale is a 11-item self-report measure for stress.
Answers range from 0 (no stress) to 10 (worst stress).
|
5 weeks
|
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Positive and Negative Affect Schedule (PANAS)
Time Frame: baseline, after 1,3,6,9 sauna bathing, after 5 weeks
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The PANAS is a 20-item self-report measure for positive and negative affect.
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baseline, after 1,3,6,9 sauna bathing, after 5 weeks
|
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Mood
Time Frame: baseline, after 1,3,6,9 sauna bathing, after 5 weeks
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Mood Adjective Check List (UMACL) will be used to assess mood (Mathews, Chamberlain & Jones, 1990, adapted to Polish by Ewa Goryńska, 2005).
UMACL measures mood in three dimensions of the core affect: Tense Arousal (minimum value: 9, maximum value: 36), Energetic Arousal (minimum value: 10, maximum value: 40), and Hedonic Tone (minimum value: 10, maximum value: 40), with higher scores representing higher levels of the mood dimensions.
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baseline, after 1,3,6,9 sauna bathing, after 5 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
November 4, 2023
First Submitted That Met QC Criteria
November 4, 2023
First Posted (Estimated)
November 9, 2023
Study Record Updates
Last Update Posted (Estimated)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 4, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- AWF_SKN_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.